semaglutide: package leaflet

1.
What Kayshild is and what it is used for

Kayshild is a medicine that contains the active substance semaglutide. It is used in combination with diet and exercise to treat adults with metabolic dysfunction-associated steatohepatitis (MASH). It is used in adults who have moderate to advanced liver fibrosis (scarring) without cirrhosis (severe, irreversible scarring). MASH is a condition where fat builds up in the liver, which can result in inflammation, liver damage and development of scar tissue.

The active substance in Kayshild, semaglutide, is similar to a natural hormone called glucagon-like peptide-1 (GLP-1). In the liver it reduces liver damage, likely due to improvements in metabolic factors, such as weight loss, improved blood sugar and lipid levels and lessening of inflammation.

2.
What you need to know before you use Kayshild

Do not use Kayshild
- if you are allergic to semaglutide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Kayshild.

The use of Kayshild is not recommended if you:
- have type 1 diabetes,
- have severely reduced kidney function,
- have moderately or severely reduced liver function and MASH,
- have severe heart failure,
- have diabetic eye disease (retinopathy).

There is little experience with Kayshild in patients:
- of 75 years and older,
- with moderately or severely reduced liver function,
- with inflammatory bowel disease,
- with MASH and a body mass index (BMI) of less than 25 kg/m2 (or a BMI less than 23 kg/m2 for Asian people).

Please consult your doctor if one of the above applies to you.

If you know that you are due to have surgery where you will be under anaesthesia (sleeping), please tell your doctor that you are taking Kayshild.

- Dehydration
During treatment with Kayshild, you may feel sick (nausea) or be sick (vomiting), or have diarrhoea. These side effects can cause dehydration (loss of fluids). It is important that you drink enough fluids to prevent dehydration. This is especially important if you have kidney problems. Talk to your doctor if you have any questions or concerns.

- Inflammation of the pancreas
If you have severe and ongoing pain in the stomach area (see section 4) – see a doctor straight away as this could be a sign of inflamed pancreas (acute pancreatitis).

- People with type 2 diabetes
Kayshild cannot be used as a substitute for insulin. Do not use Kayshild in combination with other medicines that contain GLP-1 receptor agonists (such as liraglutide, dulaglutide, exenatide or lixisenatide).

- Low blood sugar (hypoglycaemia)
Taking a sulfonylurea or an insulin with Kayshild might increase the risk of getting low blood sugar levels (hypoglycaemia). Please see section 4 for the warning signs of low blood sugar levels. Your doctor may ask you to test your blood sugar levels. This will help your doctor decide if the dose of the sulfonylurea or insulin needs to be changed to reduce the risk of low blood sugar.

- Diabetic eye disease (retinopathy)
If you have diabetic eye disease and are using insulin, this medicine may lead to a worsening of your vision, and this may require treatment. Fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disease. If you have diabetic eye disease and experience eye problems while taking this medicine, talk to your doctor.

- Sudden changes to your eyesight
If you notice a sudden loss of vision or rapidly worsening eyesight during treatment with this medicine, immediately contact your doctor for advice. This may be caused by a very rare side effect called non-arteritic anterior ischaemic optic neuropathy (NAION) (see section 4: ‘Serious side effects’). Your doctor may refer you for an eye examination and you may have to stop treatment with this medicine.

- Patients with delayed stomach emptying (gastroparesis)
If you have slow (delayed) stomach emptying (called gastroparesis), use of Kayshild may lead to serious or severe gastrointestinal adverse events. Talk to your doctor before using Kayshild.

Children and adolescents
The safety and efficacy of Kayshild in children and adolescents below 18 years of age have not been studied and Kayshild is not recommended for use in this population.

Other medicines and Kayshild
Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.

In particular, tell your doctor, pharmacist or nurse if you are using medicines containing the following:
- Warfarin or other similar medicines taken by mouth to reduce blood clotting (oral anti- coagulants). When you start treatment with e.g. warfarin or similar medicines, frequent blood testing to determine the ability of your blood to clot may be required.

Pregnancy and breast-feeding
This medicine should not be used during pregnancy, as it is not known if it may affect your unborn child. Therefore, it is recommended to use contraception while using this medicine. If you wish to become pregnant, you should stop using this medicine at least two months in advance. If you become or are pregnant, think you may be pregnant or are planning to have a baby when using this medicine, talk to your doctor straight away, as your treatment will need to be stopped.

Do not use this medicine if you are breast-feeding, as it is unknown if it passes into breast milk.

Driving and using machines
Kayshild is unlikely to affect your ability to drive and use machines. Some patients may feel dizzy when taking Kayshild mainly during the first 4 months of treatment (see section 4). If you feel dizzy, be extra careful while driving or using machines. If you need any further information, talk to your doctor, pharmacist or nurse.

People with type 2 diabetes
If you use this medicine in combination with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur which may reduce your ability to concentrate. Avoid driving or using machines if you get any signs of low blood sugar. See section 2, ‘Warnings and precautions’ for information on increased risk of low blood sugar and section 4 for the warning signs of low blood sugar. Talk to your doctor for further information.

Kayshild contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.

3.
How to use Kayshild

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much to use
The recommended dose is 2.4 mg once weekly.
Your treatment will start at a low dose, which will be gradually increased over 16 weeks of treatment.
- When you first start using Kayshild, the starting dose is 0.25 mg once weekly.
- Your doctor will instruct you to gradually increase your dose every 4 weeks until you reach the recommended dose of 2.4 mg once weekly.
- Once you reach the recommended dose of 2.4 mg, do not increase this dose further.
- In case you are feeling very bothered by sickness (nausea) or by being sick (vomiting) talk with your doctor about delaying dose escalation or lowering to the previous dose until symptoms have improved.

Usually, you will be told to follow the table below.

Dose escalation
Weekly dose
Week 1–4
0.25 mg
Week 5–8
0.5 mg
Week 9–12
1 mg
Week 13–16
1.7 mg
From week 17
2.4 mg

Your doctor will assess your treatment on a regular basis.

How Kayshild is given
Kayshild is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or muscle.
- The best places to give the injection are the front of your upper arm, upper legs or stomach.
- Before you use the pen for the first time, your doctor, pharmacist or nurse will show you how to use it.

Detailed instructions on how to use the pen are on the other side of this leaflet.

People with type 2 diabetes
Tell your doctor if you have type 2 diabetes. Your doctor may adjust the dose of your diabetes medicines to prevent you from getting low blood sugar.

When to use Kayshild
- You should use this medicine once a week and if possible, on the same day each week.
- You can give yourself the injection at any time of the day – regardless of meals.

If necessary, you can change the day of your weekly injection of this medicine as long as it has been at least 3 days since your last injection. After selecting a new dosing day, continue with once a week dosing.

If you use more Kayshild than you should
Talk to your doctor straight away. You may get side effects such as feeling sick (nausea), being sick (vomiting) or have diarrhoea, which may cause dehydration (loss of fluids).

If you forget to use Kayshild
If you forgot to inject a dose and:
- it is 5 days or less since you should have used Kayshild, use it as soon as you remember. Then inject your next dose as usual on your scheduled day.
- it is more than 5 days since you should have used Kayshild, skip the missed dose. Then inject your next dose as usual on your next scheduled day.
Do not use a double dose to make up for a forgotten dose.

If you stop using Kayshild
Do not stop using this medicine without talking to your doctor.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.
Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Common (may affect up to 1 in 10 people)
- Complications of diabetic eye disease (diabetic retinopathy). If you have diabetes you should inform your doctor if you experience eye problems, such as changes in vision, during treatment with this medicine.

Uncommon (may affect up to 1 in 100 people)
- Inflamed pancreas (acute pancreatitis). Signs of inflamed pancreas may include severe and long- lasting pain in your stomach, the pain may move to your back. You should see your doctor immediately if you experience such symptoms.

Rare (may affect up to 1 in 1 000 people)
- Severe allergic reactions (anaphylactic reactions, angioedema). You should seek immediate medical help and inform your doctor straight away if you get symptoms such as breathing difficulty, swelling, light-headedness, fast heartbeat, sweating and loss of consciousness or rapid swelling under the skin in areas such as the face, throat, arms and legs, which can be life threatening if throat swelling blocks the airway.

Very rare (may affect up to 1 in 10 000 people)
- A medical condition of the eye called non-arteritic anterior ischaemic optic neuropathy (NAION), which may cause loss of vision to one of your eyes without any pain. You should immediately contact your doctor if you notice sudden or gradually worsening eyesight (see section 2: ‘Sudden changes to your eyesight’).

Not known (frequency cannot be estimated from the available data)
- Bowel obstruction. A severe form of constipation with additional symptoms such as stomach ache, bloating, vomiting etc.

Other side effects

Very common (may affect more than 1 in 10 people)
- headache
- feeling sick (nausea)
- being sick (vomiting)
- diarrhoea
- constipation
- stomach pain
- feeling weak or tired

– these are mainly seen during dose escalation and usually go away over time.

Common (may affect up to 1 in 10 people)
- feeling dizzy
- upset stomach or indigestion
- burping
- gas (flatulence)
- bloating of the stomach
- inflamed stomach (‘gastritis’) – the signs include stomach-ache, feeling sick (nausea) or being sick (vomiting)
- reflux or heartburn – also called ‘gastro-oesophageal reflux disease’
- gallstones
- hair loss
- injection site reactions
- change in skin sensation
- a delay in the emptying of the stomach
- increase of pancreatic enzymes (such as lipase) shown in blood tests
- inflammation of the stomach and gut (gastroenteritis)
- low blood pressure
- change in the way food or drink tastes
- low blood sugar (hypoglycaemia) in patients with type 2 diabetes.

The warning signs of low blood sugar may come on suddenly. They can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking.
Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs.
Low blood sugar is more likely to happen if you also take a sulfonylurea or insulin. Your doctor may reduce your dose of these medicines before you start using this medicine.

Uncommon (may affect up to 1 in 100 people)
- fast heartbeat
- increase of pancreatic enzymes (such as amylase) shown in blood tests
- feeling dizzy or lightheaded on standing or sitting up because of a drop in blood pressure.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.
How to store Kayshild

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pen and carton after ‘EXP’. The expiry date refers to the last day of that month.

Before opening
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Keep away from the cooling element.

During use
- You can keep the pen for 6 weeks when stored at a temperature below 30 °C or in a refrigerator (2 °C – 8 °C) away from the cooling element. Do not freeze Kayshild and do not use it if it has been frozen.
- When you are not using the pen, keep the pen cap on in order to protect from light.

Do not use this medicine if you notice that the solution is not clear and colourless.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.
Contents of the pack and other information

What Kayshild contains
- The active substance is semaglutide.

Kayshild 0.25 mg solution for injection
Each pre-filled pen contains 1 mg semaglutide in 1.5 mL (0.68 mg/mL).

Kayshild 0.5 mg solution for injection
Each pre-filled pen contains 2 mg semaglutide in 3 mL (0.68 mg/mL).

Kayshild 1 mg solution for injection
Each pre-filled pen contains 4 mg semaglutide in 3 mL (1.34 mg/mL).

Kayshild 1.7 mg solution for injection
Each pre-filled pen contains 6.8 mg semaglutide in 3 mL (2.27 mg/mL).

Kayshild 2.4 mg solution for injection
Each pre-filled pen contains 9.6 mg of semaglutide in 3 mL (3.2 mg/mL).

• The other ingredients are disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid/sodium hydroxide (for pH adjustment), water for injections. See also section 2 ‘Kayshild contains sodium’ for information on sodium.

What Kayshild looks like and contents of the pack
Kayshild is a clear and colourless solution for injection in a pre-filled pen.

Each pre-filled pen contains four (4) doses. After having injected the 4 doses, there might still be solution left in the pen despite having administered correctly. Any solution left is insufficient for a dose and the pen should be disposed of.

Pack size: 1 pre-filled pen and 4 disposable NovoFine Plus needles.

Marketing Authorisation Holder
Novo Nordisk A/S
Novo Alle 1
DK-2880 Bagsvaerd
Denmark

Manufacturer
Novo Nordisk A/S
Novo Alle 1
DK-2880 Bagsvaerd
Denmark

Novo Nordisk Production SAS
45, Avenue d’Orléans
28000 Chartres
France

This leaflet was last revised in

This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine.
The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

Instructions on how to use Kayshild
Before you begin using your once-weekly Kayshild pen, always read these instructions carefully, and talk to your doctor, nurse or pharmacist about how to inject Kayshild correctly.
Kayshild pen is a dial-a-dose pen that contains four of your prescribed doses of Kayshild, corresponding to four times of once-weekly use.
Please use the table inside the lid of the carton to keep track of how many injections you have taken and how many doses remain in your pen.
Kayshild comes in five different pen variants, each containing one of the following prescribed doses of semaglutide:
0.25 mg
0.5 mg
1 mg
1.7 mg
2.4 mg

Always start by checking your pen label to make sure that it contains your prescribed dose of Kayshild.
Your pen is designed to be used with 30G, 31G, and 32G disposable needles up to a length of 8 mm.
The pack contains:
- Kayshild pen
- 4 NovoFine Plus needles
- Package leaflet
Kayshild pen (example)
Please note: Your pen may differ in size and your pen label may differ in colour from the example shown in the pictures.
These instructions apply to all Kayshild pens.
Pen cap
Pen window
Dose counter
Dose pointer
Dose selector
Dose button
Expiry date
(EXP) on back of pen label
EXP/
Batch:
Kayshild

Outer needle cap
Inner needle cap
Needle
Paper tab
NovoFine Plus needle (example)

1. Prepare your pen with a new needle

Check the name and dose of your pen to make sure that it contains your prescribed dose of Kayshild.
Pull off the pen cap.
(See figure A).
A
Check that the solution in your pen is clear and colourless.
Look through the pen window. If Kayshild looks cloudy or coloured, do not use the pen.
(See figure B).
B
Always use a new needle for each injection.

Take a needle when you are ready to take your injection. Check the paper tab and the outer needle cap for damages. If you see any damage, this could affect sterility. Dispose of it and use a new needle.

Tear off the paper tab.
(See figure C).
C
Push the needle straight onto the pen. Turn until it is on tight.
(See figure D).
D

The needle is covered by two caps. You must remove both caps. If you forget to remove both caps you will not inject any Kayshild.
Pull off the outer needle cap and keep it for later. You will need it to safely remove the needle from the pen after the injection.
Pull off the inner needle cap and dispose of it. A drop of
Kayshild may appear at the needle tip. You must still check the
Kayshild flow if you use a new pen for the first time. See ‘Check the flow with each new pen’.
Never use a bent or damaged needle. For more information about needle handling, see ‘About your needles’ below these instructions.
(See figure E).
E

Check the flow with each new pen
If your Kayshild pen is already in use, go to ‘2 Set your dose’.
Only check the Kayshild flow before your first injection with each new pen.
Turn the dose selector until you see the flow check symbol
(
).
(See figure F).
F

Make sure that the flow check symbol lines up with the dose pointer.
(See figure G).
G
Check the flow
Hold the pen with the needle pointing up.
Press and hold in the dose button until the dose counter returns to
.
The must line up with the dose pointer.
A drop of Kayshild should appear at the needle tip. This drop indicates that your pen is ready for use.
If a drop does not appear, check the flow again. This should only be done twice.
If there is still no drop, change the needle and check the flow once more.

Do not use the pen if a drop of Kayshild still does not appear.
(See figure H).
H

2. Set your dose

Turn the dose selector until the dose counter stops, and it shows your prescribed dose.
(See figure I).

I
The dashed line ( ) in the dose counter will guide you to your dose.
The dose selector clicks differently when turned forward, backwards or past your dose. You will hear a ‘click’ every time you turn the dose selector. Do not set the dose by counting the number of clicks you hear.
(See figure J).
J
Dashed line
When your prescribed dose lines up with the dose pointer, you have selected your dose. In this picture, the dose 0.25 mg is shown as an example.
If the dose counter stops before you reach your prescribed dose, see the section ‘Do you have enough Kayshild?’ below these instructions.
(See figure K).
K
Example:
0.25 mg selected

Choose your injection site
Choose upper arms, upper legs or stomach (keep a 5 cm distance from your belly button).
You may inject in the same body area each week, but make sure it is not in the same spot as used the last time.
Upper arms
Stomach
Upper legs
3. Inject your dose
Insert the needle into your skin.
Make sure you can see the dose counter. Do not cover it with your fingers. This could interrupt the injection.
(See figure L).
L
Press and hold down the dose button until the dose counter shows
.
(See figure M).
Keep pressing the dose button with the needle in your skin and slowly count to 6. The must line up with the dose pointer. You may hear or feel a click when the dose counter returns to .
(See figure N).
M

N
Count slowly
1-2-3-4-5-6
Remove the needle from your skin. If the needle is removed earlier, a stream of Kayshild may come from the needle tip and the full dose will not be delivered. If blood appears at the injection site, press lightly on the area to stop the bleeding.
You may see a drop of Kayshild at the needle tip after injecting.
This is normal and does not affect your dose.
(See figure O).
O
4. After your injection
Lead the needle tip into the outer needle cap on a flat surface without touching the needle or the outer needle cap.
Once the needle is covered, carefully push the outer needle cap completely on.
(See figure P).
P

Unscrew the needle and dispose of it carefully as instructed by your doctor, nurse, pharmacist or local authorities.
Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.
Always dispose of the needle immediately after each injection to prevent blocked needles, contamination, infection and inaccurate dosing. Never store your pen with the needle attached.
(See figure Q).
Q
Put the pen cap on your pen after each use to protect Kayshild from light.
(See figure R).
R

When the pen is empty, dispose of the pen without a needle on as instructed by your doctor, nurse, pharmacist or local authorities.
The pen cap and the empty carton can be disposed of in your household waste.
About your needles

How to identify a blocked or damaged needle
- If does not appear in the dose counter after continuously pressing the dose button, you may have used a blocked or damaged needle.
- In this case, you have not received any Kayshild – even though the dose counter has moved from the original dose that you have set.
How to handle a blocked needle
Change the needle as instructed in ‘1. Prepare your pen with a new needle’ and go to ‘2. Set your dose’.
Caring for your pen
Treat your pen with care. Rough handling or misuse may cause inaccurate dosing.
If this happens, you might not get the intended effect of Kayshild.
- See the back of this leaflet to read the storage conditions for your pen.
- Do not inject Kayshild that has been exposed to direct sunlight.
- Do not subject Kayshild to frost and never inject Kayshild that has been frozen. Dispose of the pen.
- Do not drop your pen or knock it against hard surfaces.
- Do not try to refill your pen. Once empty, it must be disposed of.
- Do not try to repair your pen or pull it apart.
- Do not expose your pen to dust, dirt or liquid.
- Do not wash, soak or lubricate your pen. It may be cleaned with a mild detergent on a moistened cloth.

Do you have enough Kayshild?
If the dose counter stops before you reach your prescribed dose, there is not enough Kayshild left for a full dose. Dispose of the pen and use a new Kayshild pen.
Important information
- Only inject one dose of Kayshild once weekly. If you do not use your Kayshild as prescribed, you may not get the intended effect of this medicine.
- If you use more than one type of injectable medicine, it is very important to check the name and dose of your pen label before use.
- Do not use this pen without help if you have poor eyesight and cannot follow these instructions.
Get help from a person with good eyesight who is trained to use the Kayshild pen.
- Always keep pen and needles out of sight and reach of others, especially children.
- Never share your pen or your needles with other people.
- Needles are for single use only. Never reuse your needles as it may lead to blocked needles, contamination, infection and inaccurate dosing.
- Caregivers must be very careful when handling used needles to prevent accidental needle stick injuries and infection.

ANNEX IV
CONCLUSIONS ON THE GRANTING OF THE CONDITIONAL MARKETING
AUTHORISATION PRESENTED BY THE EUROPEAN MEDICINES AGENCY

Conclusions presented by the European Medicines Agency on:
- Conditional marketing authorisation
The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the conditional marketing authorisation as further explained in the European Public Assessment Report.

Ozempic contains the active substance semaglutide. It helps your body reduce your blood sugar level only when blood sugar is too high and can help prevent heart disease in patients with type 2 diabetes mellitus (T2DM). It also helps to slow down deterioration of kidney function in patients with T2DM by a mechanism beyond blood glucose lowering.

Ozempic is used to treat adults (aged 18 years and older) with T2DM when diet and exercise is not enough:
- on its own – when you cannot use metformin (another diabetes medicine) or
- with other medicines for diabetes – when they are not enough to control your blood sugar levels.
These may be medicines you take by mouth or inject such as insulin.

It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or nurse.

Do not use Ozempic
- if you are allergic to semaglutide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using this medicine.

This medicine is not the same as insulin and you should not use it if:
- you develop diabetic ketoacidosis – a complication of diabetes with high blood sugar, breathing difficulty, confusion, excessive thirst, a sweet smell to the breath or a sweet or metallic taste in the mouth.

Ozempic is not an insulin and should therefore not be used as a substitute for insulin.
If you know that you are due to have surgery where you will be under anesthesia (sleeping), please tell your doctor that you are taking Ozempic.

Stomach and gut problems and dehydration

During treatment with this medicine, you may feel sick (nausea) or be sick (vomiting), or have diarrhoea. These side effects can cause dehydration (loss of fluids). It is important that you drink plenty of fluids to prevent dehydration. This is especially important if you have kidney problems. Talk to your doctor if you have any questions or concerns.

Severe and on-going stomach pain which could be due to acute pancreatitis

If you have severe and on-going pain in the stomach area – see a doctor straight away as this could be a sign of acute pancreatitis (inflamed pancreas). Please see section 4 for the warning signs of inflamed pancreas.

Low blood sugar (hypoglycaemia)

Combining a sulfonylurea or an insulin with this medicine might increase the risk of getting low blood sugar levels (hypoglycaemia). Please see section 4 for the warning signs of low blood sugar levels.
Your doctor may ask you to test your blood sugar levels. This will help your doctor decide if the dose of the sulfonylurea or insulin needs to be changed to reduce the risk of low blood sugar.

Diabetic eye disease (retinopathy)

If you have diabetic eye disease and are using insulin, this medicine may lead to a worsening of your vision, and this may require treatment. Tell your doctor if you have diabetic eye disease or if you experience eye problems during treatment with this medicine. In case you have potentially unstable diabetic eye disease, it is not recommended that you use Ozempic 2 mg.

Sudden changes to your eyesight

If you notice a sudden loss of vision or rapidly worsening eyesight during treatment with this medicine, immediately contact your doctor for advice. This may be caused by a very rare side effect called non- arteritic anterior ischaemic optic neuropathy (NAION) (See section 4: Serious side effects). Your doctor may refer you for an eye examination and you may have to stop treatment with this medicine.

Patients with delayed stomach emptying (gastroparesis)

If you have slow (delayed) stomach emptying (called gastroparesis), use of Ozempic® may lead to serious or severe gastrointestinal adverse events. Talk to your doctor before using Ozempic®.

Children and adolescents
This medicine is not recommended in children and adolescents aged under 18 years as the safety and efficacy in this age group have not yet been established.

Other medicines and Ozempic
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including herbal medicines or other medicines you bought without a prescription.

In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the following:
- Warfarin or other similar medicines taken by mouth to reduce blood clotting (oral anti- coagulants). You may need frequent blood tests to check how quickly your blood clots.
- If you are using insulin, your doctor will tell you how to reduce the dose of insulin and will recommend you to monitor your blood sugar more frequently, in order to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin).

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you might be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

This medicine should not be used during pregnancy, as it is not known if it affects an unborn baby.
Therefore, use of contraception is recommended while using this medicine. If you wish to become pregnant, discuss how to change your treatment with your doctor as you should stop using this medicine at least 2 months in advance. If you become pregnant while using this medicine, talk to your doctor right away, as your treatment will need to be changed.

Do not use this medicine if you are breast-feeding, as it is unknown if it passes into breast milk.

Driving and using machines
Ozempic is unlikely to affect your ability to drive and use machines. If you use this medicine in combination with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur which may reduce your ability to concentrate. Do not drive or use machines if you get any signs of low blood sugar. See section 2, ‘Warnings and precautions’ for information on increased risk of low blood sugar and section 4 for the warning signs of low blood sugar. Talk to your doctor for further information.

Sodium content
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much to use
- The starting dose is 0.25 mg once a week for four weeks.
- After four weeks your doctor will increase your dose to 0.5 mg once a week.
- Your doctor may increase your dose to 1 mg once a week if your blood sugar is not controlled well enough with a dose of 0.5 mg once a week.
- Your doctor may increase your dose to 2 mg once a week if your blood sugar is not controlled well enough with a dose of 1 mg once a week.

Do not change your dose unless your doctor has told you to.

How Ozempic is given
Ozempic is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or muscle.
- The best places to give the injection are the front of your thighs, the front of your waist (abdomen), or your upper arm.
- Before you use the pen for the first time, your doctor or nurse will show you how to use it.
Detailed instructions for use are on the other side of this package leaflet.

When to use Ozempic
- You should use this medicine once a week on the same day each week if possible.
- You can give yourself the injection at any time of the day – regardless of meals.

To help you remember to inject this medicine once a week only, it is recommended to note the chosen weekday (e.g. Wednesday) on the carton and to write the date on the carton every time you have injected it.

If necessary you can change the day of your weekly injection of this medicine as long as it has been at least 3 days since your last injection of it. After selecting a new dosing day, continue with once a week dosing.

If you use more Ozempic than you should
If you use more Ozempic than you should, talk to your doctor straight away. You may get side effects such as feeling sick (nausea).

If you forget to use Ozempic
If you forgot to inject a dose and:
- it is 5 days or less since you should have used Ozempic, use it as soon as you remember. Then inject your next dose as usual on your scheduled day.
- it is more than 5 days since you should have used Ozempic, skip the missed dose. Then inject your next dose as usual on your scheduled day.
Do not use a double dose to make up for a forgotten dose.

If you stop using Ozempic
Do not stop using this medicine without talking to your doctor. If you stop using it, your blood sugar levels may increase.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Common (may affect up to 1 in 10 people)
- Complications of diabetic eye disease (retinopathy) – you should tell your doctor if you get eye problems, such as changes in vision, during treatment with this medicine.

Uncommon (may affect up to 1 in 100 people)
- Inflamed pancreas (acute pancreatitis) which could cause severe pain in the stomach and back which does not go away. You should see a doctor immediately if you experience such symptoms.

Rare (may affect up to 1 in 1 000 people)
- Severe allergic reactions (anaphylactic reactions, angioedema). You must get immediate medical help and inform your doctor straight away if you get symptoms such as breathing problems, swelling of face, lips, tongue and/or throat with difficulty swallowing and a fast heartbeat.

Very Rare (may affect up to 1 in 10 000 people)
• A medical condition of the eye called non-arteritic anterior ischaemic optic neuropathy (NAION), which may cause loss of vision to one of your eyes without any pain. You should immediately contact your doctor if you notice sudden or gradually worsening eyesight (see section 2: “Sudden changes to your eyesight”).

Not known (frequency cannot be estimated from the available data)
• Bowel obstruction. A severe form of constipation with additional symptoms such as stomach ache, bloating, vomiting etc.

Other side effects

Very common (may affect more than 1 in 10 people)
- Feeling sick (nausea) – this usually goes away over time
- Diarrhoea – this usually goes away over time
- Low blood sugar (hypoglycaemia) when this medicine is used with medicines that contain a sulfonylurea or insulin.

Common (may affect up to 1 in 10 people)
- Being sick (vomiting)
- Low blood sugar (hypoglycaemia) when this medicine is used with oral diabetes medicine other than sulfonylurea or insulin.

The warning signs of low blood sugar may come on suddenly. They can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking.
Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs.
Low blood sugar is more likely to happen if you also take a sulfonylurea or insulin. Your doctor may reduce your dose of these medicines before you start using this medicine.

• Indigestion
• Inflamed stomach (‘gastritis’) – the signs include stomach ache, feeling sick (nausea) or being sick (vomiting)
• Reflux or heartburn – also called ‘gastro-esophageal reflux disease’ (GERD)
• Stomach pain
• Bloating of the stomach
• Constipation
• Burping
• Gall stones
• Dizziness
• Tiredness
• Weight loss
• Less appetite
• Gas (flatulence)
• Increase of pancreatic enzymes (such as lipase and amylase)
• Headache.

Uncommon (may affect up to 1 in 100 people)
- Change in the way food or drink tastes
- Fast pulse
- Injection site reactions – such as bruising, pain, irritation, itching and rash
- Allergic reactions like rash, itching or hives
- A delay in the emptying of the stomach.

Not known (frequency cannot be estimated from the available data)
- Change in skin sensation.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the pen label and carton after ’EXP’.
The expiry date refers to the last day of that month.

Before opening:

Store in a refrigerator (2 °C–8 °C). Do not freeze. Keep away from the cooling element. Keep the pen cap on in order to protect from light.

After first opening:

• You can keep the pen for 6 weeks when stored at a temperature below 30 °C or in a refrigerator (2 °C–8 °C) away from the cooling element. Do not freeze Ozempic and do not use it if it has been frozen.
• When you are not using the pen, keep the pen cap on in order to protect from light.

Do not use this medicine if you notice that the solution is not clear and colourless or almost colourless.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Ozempic contains
- The active substance is semaglutide. One ml solution for injection contains 1.34 mg semaglutide. One pre-filled pen contains 2 mg semaglutide in 1.5 ml solution. Each dose contains 0.25 mg of semaglutide in 0.19 ml.
- The other ingredients are: disodium phosphate dihydrate, propylene glycol, phenol, water for injections, sodium hydroxide/hydrochloric acid (for pH adjustment). See also section 2, ‘Sodium content’.

What Ozempic looks like and contents of the pack
Ozempic is a clear and colourless or almost colourless solution for injection in a pre-filled pen.
Each pre-filled pen contains 1.5 ml of solution, delivering 4 doses of 0.25 mg.

Ozempic 0.25 mg solution for injection is available in the following pack size:
1 pen and 4 disposable NovoFine Plus needles.

Marketing Authorisation Holder
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

Novo Nordisk Production SAS
45, Avenue d’Orléans
28000 Chartres
France

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.

Instructions for use

Ozempic 0.25 mg solution for injection in pre-filled pen semaglutide

Instructions on how to use Ozempic 0.25 mg solution for injection in pre-filled pen

Please read these instructions carefully before using your
Ozempic pre-filled pen.
Talk to your doctor, nurse or pharmacist about how to inject
Ozempic correctly.
Only use the medicine in this pen as prescribed.
Start by checking your pen to make sure that it contains
Ozempic 0.25 mg, then look at the illustrations below to get to know the different parts of your pen and needle.
If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help.
Get help from a person with good eyesight who knows how to use the Ozempic pre-filled pen.
Your pen is a pre-filled dial-a-dose pen. It contains 2 mg of semaglutide, and you can only select doses of 0.25 mg. One unused pen contains four doses of 0.25 mg. After having injected the four doses, there will still be solution left in the pen.
The pen should be disposed of.

Use the table inside the lid of the carton to keep track of how many injections you have taken and when you took the injections.

Your pen is designed to be used with 30G, 31G, and 32G disposable needles up to a length of 8 mm.
NovoFine Plus needles are included in the pack.

Ozempic pre-filled pen and needle (example)
Pen cap
Outer needle cap
Inner needle cap
Needle
Paper tab
Pen window
Pen label
Dose counter
Dose pointer
Dose selector
Dose button
Flow check symbol

Important information
Pay special attention to these notes, as they are important for safe use of the pen.
1. Prepare your pen with a new needle
- Check the name and coloured label of your pen, to make sure that it contains Ozempic 0.25 mg. This is especially important if you take more than one type of injectable medicine. Using the wrong medicine could be harmful to your health.
- Pull off the pen cap.
A

- Check that the solution in your pen is clear and colourless. Look through the pen window. If the solution looks cloudy or coloured, do not use the pen.
B
- Take a new needle.
Check the paper tab and the outer needle cap for damages that could affect sterility. If any damage is seen use a new needle.
- Tear off the paper tab.
C
Make sure to attach the needle correctly.

- Push the needle straight onto the pen.
- Turn until it is on tight.
D
The needle is covered by two caps. You must remove both caps. If you forget to remove both caps, you will not inject any solution.

- Pull off the outer needle cap and keep it for later. You will need it after the injection, to safely remove the needle from the pen.
E

• Pull off the inner needle cap and throw it away. If you try to put it back on, you may accidentally stick yourself with the needle.

A drop of solution may appear at the needle tip. This is normal, but you must still check the flow, if you use a new pen for the first time. See step 2 ‘Check the flow with each new pen’.
Do not attach a new needle to your pen until you are ready to take your injection.
F

Always use a new needle for each injection.

This may prevent blocked needles, contamination, infection and inaccurate dosing.

Never use a bent or damaged needle.
2. Check the flow with each new pen
- If your pen is already in use, go to step 3 ‘Select your dose’. Only check the flow before your first injection with each new pen.

- Turn the dose selector to the flow check symbol (
) right past ‘0’. Make sure the flow check symbol lines up with the pointer.
A
Flow check symbol selected

• Hold the pen with the needle pointing up.

Press and hold in the dose button until the dose counter returns to ‘0’. The ‘0’ must line up with the dose pointer.

A drop of solution should appear at the needle tip.
B
A small drop may remain at the needle tip, but it will not be injected.
If no drop appears, repeat step 2 ‘Check the flow with each new pen’ up to 6 times. If there is still no drop, change the needle and repeat step 2 ‘Check the flow with each new pen’ once more.
Dispose of the pen and use a new one if a drop of solution still does not appear.

Always make sure that a drop appears at the needle tip before you use a new pen for the first time.
This makes sure that the solution flows.

If no drop appears, you will not inject any medicine, even though the dose counter may move. This may indicate a blocked or damaged needle.

If you do not check the flow before your first injection with each new pen, you may not get the prescribed dose and the intended effect of Ozempic.
3. Select your dose
- Turn the dose selector to select 0.25 mg.

Keep turning until the dose counter stops and shows
0.25 mg.

A
0.25 mg selected
Only the dose counter and dose pointer will show that 0.25 mg has been selected.
You can only select 0.25 mg per dose.
The dose selector clicks differently when turned forwards, backwards or past 0.25 mg. Do not count the pen clicks.

Always use the dose counter and the dose pointer to see that 0.25 mg has been selected before injecting this medicine.

Do not count the pen clicks.

Only doses of 0.25 mg must be selected with the dose selector. 0.25 mg must line up precisely with the dose pointer to ensure that you get a correct dose.
4. Inject your dose
- Insert the needle into your skin as your doctor or nurse has shown you.
- Make sure you can see the dose counter. Do not cover it with your fingers. This could interrupt the injection.
A

• Press and hold down the dose button. Watch as the dose counter returns to ‘0’. The ‘0’ must line up with the dose pointer. You may then hear or feel a click.

- Continue pressing the dose button while keeping the needle in your skin.
B
- Count slowly to 6, while keeping the dose button pressed.
- If the needle is removed earlier, you may see a stream of solution coming from the needle tip. If so, the full dose will not be delivered.
C
1-2-3-4-5-6
Count slowly:
- Remove the needle from your skin. You can then release the dose button.
If blood appears at the injection site, press lightly.
D
You may see a drop of solution at the needle tip after injecting. This is normal and does not affect your dose.

Always watch the dose counter to know how many mg you inject. Hold the dose button down until the dose counter returns to ‘0’.

How to identify a blocked or damaged needle
- If ‘0’ does not appear in the dose counter after continuously pressing the dose button, you may have used a blocked or damaged needle.
- In this case, you have not received any medicine – even though the dose counter has moved from the original dose that you have set.

How to handle a blocked needle

Change the needle as described in step 5 ‘After your injection’ and repeat all steps starting with step 1 ‘Prepare your pen with a new needle’. Make sure you select the full dose you need.

Never touch the dose counter when you inject. This can interrupt the injection.
5. After your injection
Always dispose of the needle after each injection to ensure convenient injections and prevent blocked needles.
If the needle is blocked, you will not inject any medicine.

- Lead the needle tip into the outer needle cap on a flat surface without touching the needle or the outer needle cap.
A

- Once the needle is covered, carefully push the outer needle cap completely on.
- Unscrew the needle and dispose of it carefully as instructed by your doctor, nurse, pharmacist or local authorities.
B

- Put the pen cap on your pen after each use to protect the solution from light.
C
When the pen is to be disposed of, do it without a needle on as instructed by your doctor, nurse, pharmacist or local authorities.

Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.

Always remove the needle from your pen immediately after each injection.

This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.

Further important information
- Always keep your pen and needles out of the sight and reach of others, especially children.
- Never share your pen or your needles with other people.
- Caregivers must be very careful when handling used needles to prevent needle injury and cross- infection.
Caring for your pen
Treat your pen with care. Rough handling or misuse may cause inaccurate dosing. If this happens you might not get the intended effect of this medicine.
- Do not leave the pen in a car or another place where it can get too hot or too cold.
- Do not inject Ozempic which has been frozen. If you do that, you might not get the intended effect of this medicine.
- Do not inject Ozempic which has been exposed to direct sunlight. If you do that, you might not get the intended effect of this medicine.
- Do not expose your pen to dust, dirt or liquid.
- Do not wash, soak or lubricate your pen. It may be cleaned with a mild detergent on a moistened cloth.
- Do not drop your pen or knock it against hard surfaces. If you drop it or suspect a problem, attach a new needle and check the flow before you inject.
- Do not try to refill your pen.
- Do not try to repair your pen or pull it apart.

Ozempic contains the active substance semaglutide. It helps your body reduce your blood sugar level only when blood sugar is too high and can help prevent heart disease in patients with type 2 diabetes mellitus (T2DM). It also helps to slow down deterioration of kidney function in patients with T2DM by a mechanism beyond blood glucose lowering.

Ozempic is used to treat adults (aged 18 years and older) with T2DM when diet and exercise is not enough:
- on its own – when you cannot use metformin (another diabetes medicine) or
- with other medicines for diabetes – when they are not enough to control your blood sugar levels.
These may be medicines you take by mouth or inject such as insulin.

It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or nurse.

Do not use Ozempic
- if you are allergic to semaglutide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using this medicine.

This medicine is not the same as insulin and you should not use it if:
- you develop diabetic ketoacidosis – a complication of diabetes with high blood sugar, breathing difficulty, confusion, excessive thirst, a sweet smell to the breath or a sweet or metallic taste in the mouth.

Ozempic is not an insulin and should therefore not be used as a substitute for insulin.
If you know that you are due to have surgery where you will be under anesthesia (sleeping), please tell your doctor that you are taking Ozempic.

Stomach and gut problems and dehydration

During treatment with this medicine, you may feel sick (nausea) or be sick (vomiting), or have diarrhoea. These side effects can cause dehydration (loss of fluids). It is important that you drink plenty of fluids to prevent dehydration. This is especially important if you have kidney problems. Talk to your doctor if you have any questions or concerns.

Severe and on-going stomach pain which could be due to acute pancreatitis

If you have severe and on-going pain in the stomach area – see a doctor straight away as this could be a sign of acute pancreatitis (inflamed pancreas). Please see section 4 for the warning signs of inflamed pancreas.

Low blood sugar (hypoglycaemia)

Combining a sulfonylurea or an insulin with this medicine might increase the risk of getting low blood sugar levels (hypoglycaemia). Please see section 4 for the warning signs of low blood sugar levels.
Your doctor may ask you to test your blood sugar levels. This will help your doctor decide if the dose of the sulfonylurea or insulin needs to be changed to reduce the risk of low blood sugar.

Diabetic eye disease (retinopathy)

If you have diabetic eye disease and are using insulin, this medicine may lead to a worsening of your vision, and this may require treatment. Tell your doctor if you have diabetic eye disease or if you experience eye problems during treatment with this medicine. In case you have potentially unstable diabetic eye disease, it is not recommended that you use Ozempic 2 mg.

Sudden changes to your eyesight

If you notice a sudden loss of vision or rapidly worsening eyesight during treatment with this medicine, immediately contact your doctor for advice. This may be caused by a very rare side effect called non- arteritic anterior ischaemic optic neuropathy (NAION) (See section 4: Serious side effects). Your doctor may refer you for an eye examination and you may have to stop treatment with this medicine.

Patients with delayed stomach emptying (gastroparesis)

If you have slow (delayed) stomach emptying (called gastroparesis), use of Ozempic® may lead to serious or severe gastrointestinal adverse events. Talk to your doctor before using Ozempic®.

Children and adolescents
This medicine is not recommended in children and adolescents aged under 18 years as the safety and efficacy in this age group have not yet been established.

Other medicines and Ozempic
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including herbal medicines or other medicines you bought without a prescription.

In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the following:
- Warfarin or other similar medicines taken by mouth to reduce blood clotting (oral anti- coagulants). You may need frequent blood tests to check how quickly your blood clots.
- If you are using insulin, your doctor will tell you how to reduce the dose of insulin and will recommend you to monitor your blood sugar more frequently, in order to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin).

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you might be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

This medicine should not be used during pregnancy, as it is not known if it affects an unborn baby.
Therefore, use of contraception is recommended while using this medicine. If you wish to become pregnant, discuss how to change your treatment with your doctor as you should stop using this medicine at least 2 months in advance. If you become pregnant while using this medicine, talk to your doctor right away, as your treatment will need to be changed.

Do not use this medicine if you are breast-feeding, as it is unknown if it passes into breast milk.

Driving and using machines
Ozempic is unlikely to affect your ability to drive and use machines. If you use this medicine in combination with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur which may reduce your ability to concentrate. Do not drive or use machines if you get any signs of low blood sugar. See section 2, ‘Warnings and precautions’ for information on increased risk of low blood sugar and section 4 for the warning signs of low blood sugar. Talk to your doctor for further information.

Sodium content
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much to use
- The starting dose is 0.25 mg once a week for four weeks.
- After four weeks your doctor will increase your dose to 0.5 mg once a week.
- Your doctor may increase your dose to 1 mg once a week if your blood sugar is not controlled well enough with a dose of 0.5 mg once a week.
- Your doctor may increase your dose to 2 mg once a week if your blood sugar is not controlled well enough with a dose of 1 mg once a week.

Do not change your dose unless your doctor has told you to.

How Ozempic is given
Ozempic is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or muscle.
- The best places to give the injection are the front of your thighs, the front of your waist (abdomen), or your upper arm.
- Before you use the pen for the first time, your doctor or nurse will show you how to use it.
Detailed instructions for use are on the other side of this package leaflet.

When to use Ozempic
- You should use this medicine once a week on the same day each week if possible.
- You can give yourself the injection at any time of the day – regardless of meals.

To help you remember to inject this medicine once a week only, it is recommended to note the chosen weekday (e.g. Wednesday) on the carton and to write the date on the carton every time you have injected it.

If necessary you can change the day of your weekly injection of this medicine as long as it has been at least 3 days since your last injection of it. After selecting a new dosing day, continue with once a week dosing.

If you use more Ozempic than you should
If you use more Ozempic than you should, talk to your doctor straight away. You may get side effects such as feeling sick (nausea).

If you forget to use Ozempic
If you forgot to inject a dose and:
- it is 5 days or less since you should have used Ozempic, use it as soon as you remember. Then inject your next dose as usual on your scheduled day.
- it is more than 5 days since you should have used Ozempic, skip the missed dose. Then inject your next dose as usual on your scheduled day.
Do not use a double dose to make up for a forgotten dose.

If you stop using Ozempic
Do not stop using this medicine without talking to your doctor. If you stop using it, your blood sugar levels may increase.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Common (may affect up to 1 in 10 people)
- Complications of diabetic eye disease (retinopathy) – you should tell your doctor if you get eye problems, such as changes in vision, during treatment with this medicine.

Uncommon (may affect up to 1 in 100 people)
- Inflamed pancreas (acute pancreatitis) which could cause severe pain in the stomach and back which does not go away. You should see a doctor immediately if you experience such symptoms.

Rare (may affect up to 1 in 1 000 people)
- Severe allergic reactions (anaphylactic reactions, angioedema). You must get immediate medical help and inform your doctor straight away if you get symptoms such as breathing problems, swelling of face, lips, tongue and/or throat with difficulty swallowing and a fast heartbeat.

Very Rare (may affect up to 1 in 10 000 people)
• A medical condition of the eye called non-arteritic anterior ischaemic optic neuropathy (NAION), which may cause loss of vision to one of your eyes without any pain. You should immediately contact your doctor if you notice sudden or gradually worsening eyesight (see section 2: “Sudden changes to your eyesight”).

Not known (frequency cannot be estimated from the available data)
- Bowel obstruction. A severe form of constipation with additional symptoms such as stomach ache, bloating, vomiting etc.

Other side effects

Very common (may affect more than 1 in 10 people)
- Feeling sick (nausea) – this usually goes away over time
- Diarrhoea – this usually goes away over time
- Low blood sugar (hypoglycaemia) when this medicine is used with medicines that contain a sulfonylurea or insulin.

Common (may affect up to 1 in 10 people)
- Being sick (vomiting)
- Low blood sugar (hypoglycaemia) when this medicine is used with oral diabetes medicine other than sulfonylurea or insulin.

The warning signs of low blood sugar may come on suddenly. They can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking.
Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs.
Low blood sugar is more likely to happen if you also take a sulfonylurea or insulin. Your doctor may reduce your dose of these medicines before you start using this medicine.

• Indigestion
• Inflamed stomach (‘gastritis’) – the signs include stomach ache, feeling sick (nausea) or being sick (vomiting)
• Reflux or heartburn – also called ‘gastro-esophageal reflux disease’ (GERD)
• Stomach pain
• Bloating of the stomach
• Constipation
• Burping
• Gall stones
• Dizziness
• Tiredness
• Weight loss
• Less appetite
• Gas (flatulence)
• Increase of pancreatic enzymes (such as lipase and amylase)
• Headache.

Uncommon (may affect up to 1 in 100 people)
- Change in the way food or drink tastes
- Fast pulse
- Injection site reactions – such as bruising, pain, irritation, itching and rash
- Allergic reactions like rash, itching or hives
- A delay in the emptying of the stomach.

Not known (frequency cannot be estimated from the available data)
- Change in skin sensation.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the pen label and carton after ’EXP’.
The expiry date refers to the last day of that month.

Before opening:

Store in a refrigerator (2 °C–8 °C). Do not freeze. Keep away from the cooling element. Keep the pen cap on in order to protect from light.

After first opening:

Ozempic 0.5 mg (4 dose pen)
- You can keep the pen for 6 weeks when stored at a temperature below 30 °C or in a refrigerator (2 °C–8 °C) away from the cooling element. Do not freeze Ozempic and do not use it if it has been frozen.

Ozempic 0.5 mg (8 dose pen)
- You can keep the pen for 8 weeks when stored at a temperature below 30 °C or in a refrigerator (2 °C–8 °C) away from the cooling element. Do not freeze Ozempic and do not use it if it has been frozen.

• When you are not using the pen, keep the pen cap on in order to protect from light.

Do not use this medicine if you notice that the solution is not clear and colourless or almost colourless.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Ozempic contains
- The active substance is semaglutide.
- Ozempic 4 dose pens
- 1.5 ml: One ml solution for injection contains 1.34 mg semaglutide. One pre-filled pen contains 2 mg semaglutide in 1.5 ml solution. Each dose contains 0.5 mg of semaglutide in 0.37 ml.
- 3 ml: One ml solution for injection contains 0.68 mg semaglutide. One pre-filled pen contains 2 mg semaglutide in 3 ml solution. Each dose contains 0.5 mg of semaglutide in 0.74 ml.

• Ozempic 8 dose pen

• 3 ml: One ml solution for injection contains 1.34 mg semaglutide. One pre-filled pen contains 4 mg semaglutide in 3 ml solution. Each dose contains 0.5 mg of semaglutide in 0.37 ml.
• The other ingredients are: disodium phosphate dihydrate, propylene glycol, phenol, water for injections, sodium hydroxide/hydrochloric acid (for pH adjustment). See also section 2, ‘Sodium content’.

What Ozempic looks like and contents of the pack
Ozempic is a clear and colourless or almost colourless solution for injection in a pre-filled pen.
1.5 ml: Each pre-filled pen contains 1.5 ml of solution, delivering 4 doses of 0.5 mg.
3 ml: Each pre-filled pen contains 3 ml of solution, delivering 4 doses of 0.5 mg.
3 ml: Each pre-filled pen contains 3 ml of solution, delivering 8 doses of 0.5 mg.

Ozempic 0.5 mg solution for injection is available in the following pack sizes:
1 pen and 4 disposable NovoFine Plus needles.
1 pen and 8 disposable NovoFine Plus needles.
3 pens and 12 disposable NovoFine Plus needles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

Novo Nordisk Production SAS
45, Avenue d’Orléans
28000 Chartres
France

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.

Instructions for use

Ozempic 0.5 mg solution for injection in pre-filled pen delivering 4 doses semaglutide

Instructions on how to use Ozempic 0.5 mg solution for injection in pre-filled pen

Please read these instructions carefully before using your
Ozempic pre-filled pen. Talk to your doctor, nurse or pharmacist about how to inject Ozempic correctly.
Start by checking your pen to make sure that it contains
Ozempic 0.5 mg, then look at the illustrations below to get to know the different parts of your pen and needle.
If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help.
Get help from a person with good eyesight who knows how to use the Ozempic pre-filled pen.
Your pen is a pre-filled dial-a-dose pen. It contains 2 mg of semaglutide, and you can only select doses of 0.5 mg. One unused pen contains four doses of 0.5 mg.

Use the table inside the lid of the carton to keep track of how many injections you have taken and when you took the injections.

Your pen is designed to be used with 30G, 31G, and 32G disposable needles up to a length of 8 mm.
NovoFine Plus needles are included in the pack.

Please note: Your pen may differ in size from the pen shown in the picture. These instructions apply to all Ozempic 0.5 mg pens.
Ozempic pre-filled pen and needle (example)
Pen cap
Outer needle cap
Inner needle cap
Needle
Paper tab
Pen window
Pen label
Dose counter
Dose pointer
Dose selector
Dose button
Flow check symbol

Important information
Pay special attention to these notes, as they are important for safe use of the pen.
1. Prepare your pen with a new needle
- Check the name and coloured label of your pen, to make sure that it contains Ozempic 0.5 mg. This is especially important if you take more than one type of injectable medicine. Using the wrong medicine could be harmful to your health.
- Pull off the pen cap.
A

- Check that the solution in your pen is clear and colourless. Look through the pen window. If the solution looks cloudy or coloured, do not use the pen.
B
- Take a new needle.
Check the paper tab and the outer needle cap for damages that could affect sterility. If any damage is seen use a new needle.
- Tear off the paper tab.
C
Make sure to attach the needle correctly.

- Push the needle straight onto the pen.
- Turn until it is on tight.
D
The needle is covered by two caps. You must remove both caps. If you forget to remove both caps, you will not inject any solution.

- Pull off the outer needle cap and keep it for later. You will need it after the injection, to safely remove the needle from the pen.
E

• Pull off the inner needle cap and throw it away. If you try to put it back on, you may accidentally stick yourself with the needle.

A drop of solution may appear at the needle tip. This is normal, but you must still check the flow, if you use a new pen for the first time. See step 2 ‘Check the flow with each new pen’.
Do not attach a new needle to your pen until you are ready to take your injection.
F

Always use a new needle for each injection.

This may prevent blocked needles, contamination, infection and inaccurate dosing.

Never use a bent or damaged needle.
2. Check the flow with each new pen
- If your pen is already in use, go to step 3 ‘Select your dose’. Only check the flow before your first injection with each new pen.

- Turn the dose selector to the flow check symbol (
) right past ‘0’. Make sure the flow check symbol lines up with the pointer.
A
Flow check symbol selected

• Hold the pen with the needle pointing up.

Press and hold in the dose button until the dose counter returns to ‘0’. The ‘0’ must line up with the dose pointer.

A drop of solution should appear at the needle tip.
B
A small drop may remain at the needle tip, but it will not be injected.
If no drop appears, repeat step 2 ‘Check the flow with each new pen’ up to 6 times. If there is still no drop, change the needle and repeat step 2 ‘Check the flow with each new pen’ once more.
Dispose of the pen and use a new one if a drop of solution still does not appear.

Always make sure that a drop appears at the needle tip before you use a new pen for the first time.
This makes sure that the solution flows.

If no drop appears, you will not inject any medicine, even though the dose counter may move. This may indicate a blocked or damaged needle.

If you do not check the flow before your first injection with each new pen, you may not get the prescribed dose and the intended effect of Ozempic.
3. Select your dose
- Turn the dose selector to select 0.5 mg.

Keep turning until the dose counter stops and shows
0.5 mg.

0.5 mg selected
A
Only the dose counter and dose pointer will show that 0.5 mg has been selected.
You can only select 0.5 mg per dose. When your pen contains less than 0.5 mg, the dose counter stops before 0.5 is shown.
The dose selector clicks differently when turned forwards, backwards or past 0.5 mg. Do not count the pen clicks.

Always use the dose counter and the dose pointer to see that 0.5 mg has been selected before injecting this medicine.

Do not count the pen clicks.

Only doses of 0.5 mg must be selected with the dose selector. 0.5 mg must line up precisely with the dose pointer to ensure that you get a correct dose.
How much solution is left
- To see how much solution is left, use the dose counter:
Turn the dose selector until the dose counter stops.
If it shows 0.5, at least 0.5 mg is left in your pen.
If the dose counter stops before 0.5 mg, there is not enough solution left for a full dose of 0.5 mg.
A
Dose counter stopped:
0.5 mg left

If there is not enough solution left in your pen for a full dose, do not use it. Use a new Ozempic pen.
4. Inject your dose

- Insert the needle into your skin as your doctor or nurse has shown you.
- Make sure you can see the dose counter. Do not cover it with your fingers. This could interrupt the injection.
A
- Press and hold down the dose button. Watch as the dose counter returns to ‘0’. The ‘0’ must line up with the dose pointer. You may then hear or feel a click.

- Continue pressing the dose button while keeping the needle in your skin.
B
- Count slowly to 6, while keeping the dose button pressed.
- If the needle is removed earlier, you may see a stream of solution coming from the needle tip. If so, the full dose will not be delivered.
C
1-2-3-4-5-6
Count slowly:
- Remove the needle from your skin. You can then release the dose button.
If blood appears at the injection site, press lightly.
D
You may see a drop of solution at the needle tip after injecting. This is normal and does not affect your dose.

Always watch the dose counter to know how many mg you inject. Hold the dose button down until the dose counter returns to ‘0’.

How to identify a blocked or damaged needle
- If ‘0’ does not appear in the dose counter after continuously pressing the dose button, you may have used a blocked or damaged needle.
- In this case, you have not received any medicine – even though the dose counter has moved from the original dose that you have set.

How to handle a blocked needle

Change the needle as described in step 5 ‘After your injection’ and repeat all steps starting with step 1 ‘Prepare your pen with a new needle’. Make sure you select the full dose you need.

Never touch the dose counter when you inject. This can interrupt the injection.
5. After your injection
Always dispose of the needle after each injection to ensure convenient injections and prevent blocked needles. If the needle is blocked, you will not inject any medicine.

- Lead the needle tip into the outer needle cap on a flat surface without touching the needle or the outer needle cap.
A

- Once the needle is covered, carefully push the outer needle cap completely on.
- Unscrew the needle and dispose of it carefully as instructed by your doctor, nurse, pharmacist or local authorities.
B
- Put the pen cap on your pen after each use to protect the solution from light.
C
When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist or local authorities.

Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.

Always remove the needle from your pen immediately after each injection.

This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.

Further important information
- Always keep your pen and needles out of the sight and reach of others, especially children.
- Never share your pen or your needles with other people.
- Caregivers must be very careful when handling used needles to prevent needle injury and cross- infection.
Caring for your pen
Treat your pen with care. Rough handling or misuse may cause inaccurate dosing. If this happens you might not get the intended effect of this medicine.
- Do not leave the pen in a car or another place where it can get too hot or too cold.
- Do not inject Ozempic which has been frozen. If you do that, you might not get the intended effect of this medicine.
- Do not inject Ozempic which has been exposed to direct sunlight. If you do that, you might not get the intended effect of this medicine.
- Do not expose your pen to dust, dirt or liquid.
- Do not wash, soak or lubricate your pen. It may be cleaned with a mild detergent on a moistened cloth.
- Do not drop your pen or knock it against hard surfaces. If you drop it or suspect a problem, attach a new needle and check the flow before you inject.
- Do not try to refill your pen. Once empty, it must be disposed of.
- Do not try to repair your pen or pull it apart.

Instructions for use

Ozempic 0.5 mg solution for injection in pre-filled pen delivering 8 doses semaglutide

Instructions on how to use Ozempic 0.5 mg solution for injection in pre-filled pen Please read these instructions carefully before using your Ozempic pre-filled pen. Talk to your doctor, nurse or pharmacist about how to inject Ozempic correctly.
Start by checking your pen to make sure that it contains
Ozempic 0.5 mg, then look at the illustrations below to get to know the different parts of your pen and needle.
If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help.
Get help from a person with good eyesight who knows how to use the Ozempic pre-filled pen.
Your pen is a pre-filled dial-a-dose pen. It contains 4 mg of semaglutide, and you can only select doses of 0.5 mg. One unused pen contains eight doses of 0.5 mg.

After having injected the intended doses, there will still be solution left in the pen. The pen should be disposed of.

Use the table inside the lid of the carton to keep track of how many injections you have taken and when you took the injections.

Your pen is designed to be used with 30G, 31G, and 32G disposable needles up to a length of 8 mm.
NovoFine Plus needles are included in the pack.

Ozempic pre-filled pen and needle (example)
Pen cap
Outer needle cap
Inner needle cap
Needle
Paper tab
Pen window
Pen label
Dose counter
Dose pointer
Dose selector
Dose button
Flow check symbol
Important information
Pay special attention to these notes, as they are important for safe use of the pen.
1. Prepare your pen with a new needle

- Check the name and coloured label of your pen, to make sure that it contains Ozempic 0.5 mg. This is especially important if you take more than one type of injectable medicine. Using the wrong medicine could be harmful to your health.
- Pull off the pen cap.
A
- Check that the solution in your pen is clear and colourless. Look through the pen window. If the solution looks cloudy or coloured, do not use the pen.
B
- Take a new needle.
Check the paper tab and the outer needle cap for damages that could affect sterility. If any damage is seen use a new needle.
- Tear off the paper tab.

C

Make sure to attach the needle correctly.

- Push the needle straight onto the pen.
- Turn until it is on tight.
D

The needle is covered by two caps. You must remove both caps. If you forget to remove both caps, you will not inject any solution.

- Pull off the outer needle cap and keep it for later. You will need it after the injection, to safely remove the needle from the pen.
E

• Pull off the inner needle cap and throw it away. If you try to put it back on, you may accidentally stick yourself with the needle.

A drop of solution may appear at the needle tip. This is normal, but you must still check the flow, if you use a new pen for the first time. See step 2 ‘Check the flow with each new pen’.
Do not attach a new needle to your pen until you are ready to take your injection.
F

Always use a new needle for each injection.

This may prevent blocked needles, contamination, infection and inaccurate dosing.
Never use a bent or damaged needle.
2. Check the flow with each new pen
- If your pen is already in use, go to step 3 ‘Select your dose’. Only check the flow before your first injection with each new pen.

- Turn the dose selector to the flow check symbol (
) right past ‘0’. Make sure the flow check symbol lines up with the pointer.
A
Flow check symbol selected

• Hold the pen with the needle pointing up.

Press and hold in the dose button until the dose counter returns to ‘0’. The ‘0’ must line up with the dose pointer.

A drop of solution should appear at the needle tip.
B
A small drop may remain at the needle tip, but it will not be injected.
If no drop appears, repeat step 2 ‘Check the flow with each new pen’ up to 6 times. If there is still no drop, change the needle and repeat step 2 ‘Check the flow with each new pen’ once more.
Dispose of the pen and use a new one if a drop of solution still does not appear.
Always make sure that a drop appears at the needle tip before you use a new pen for the first time.
This makes sure that the solution flows.

If no drop appears, you will not inject any medicine, even though the dose counter may move. This may indicate a blocked or damaged needle.

If you do not check the flow before your first injection with each new pen, you may not get the prescribed dose and the intended effect of Ozempic.
3. Select your dose
- Turn the dose selector to select 0.5 mg.

Keep turning until the dose counter stops and shows
0.5 mg.
0.5 mg selected
A
Only the dose counter and dose pointer will show that 0.5 mg has been selected.
You can only select 0.5 mg per dose. When your pen contains less than 0.5 mg, the dose counter stops before 0.5 is shown.
The dose selector clicks differently when turned forwards, backwards or past 0.5 mg. Do not count the pen clicks.
Always use the dose counter and the dose pointer to see that 0.5 mg has been selected before injecting this medicine.

Do not count the pen clicks.

Only doses of 0.5 mg must be selected with the dose selector. 0.5 mg must line up precisely with the dose pointer to ensure that you get a correct dose.
How much solution is left
- To see how much solution is left, use the dose counter:
Turn the dose selector until the dose counter stops.

If it shows 0.5, at least 0.5 mg is left in your pen.

If the dose counter stops before 0.5 mg, there is not enough solution left for a full dose of 0.5 mg.
A
Dose counter stopped:
0.5 mg left
If there is not enough solution left in your pen for a full dose, do not use it. Use a new Ozempic pen.

4. Inject your dose
- Insert the needle into your skin as your doctor or nurse has shown you.
- Make sure you can see the dose counter. Do not cover it with your fingers. This could interrupt the injection.
A
- Press and hold down the dose button. Watch as the dose counter returns to ‘0’. The ‘0’ must line up with the dose pointer. You may then hear or feel a click.

- Continue pressing the dose button while keeping the needle in your skin.
B
- Count slowly to 6, while keeping the dose button pressed.

- If the needle is removed earlier, you may see a stream of solution coming from the needle tip. If so, the full dose will not be delivered.
C
1-2-3-4-5-6
Count slowly:
- Remove the needle from your skin. You can then release the dose button.
If blood appears at the injection site, press lightly.
D

You may see a drop of solution at the needle tip after injecting. This is normal and does not affect your dose.
Always watch the dose counter to know how many mg you inject. Hold the dose button down until the dose counter returns to ‘0’.

How to identify a blocked or damaged needle
- If ‘0’ does not appear in the dose counter after continuously pressing the dose button, you may have used a blocked or damaged needle.
- In this case, you have not received any medicine – even though the dose counter has moved from the original dose that you have set.

How to handle a blocked needle

Change the needle as described in step 5 ‘After your injection’ and repeat all steps starting with step 1 ‘Prepare your pen with a new needle’. Make sure you select the full dose you need.

Never touch the dose counter when you inject. This can interrupt the injection.
5. After your injection

Always dispose of the needle after each injection to ensure convenient injections and prevent blocked needles.
If the needle is blocked, you will not inject any medicine.

- Lead the needle tip into the outer needle cap on a flat surface without touching the needle or the outer needle cap.
A

- Once the needle is covered, carefully push the outer needle cap completely on.
- Unscrew the needle and dispose of it carefully as instructed by your doctor, nurse, pharmacist or local authorities.
B
- Put the pen cap on your pen after each use to protect the solution from light.
C
When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist or local authorities.
Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.
Always remove the needle from your pen immediately after each injection.

This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.
Further important information
- Always keep your pen and needles out of the sight and reach of others, especially children.
- Never share your pen or your needles with other people.
- Caregivers must be very careful when handling used needles to prevent needle injury and cross- infection.
Caring for your pen
Treat your pen with care. Rough handling or misuse may cause inaccurate dosing. If this happens you might not get the intended effect of this medicine.
- Do not leave the pen in a car or another place where it can get too hot or too cold.
- Do not inject Ozempic which has been frozen. If you do that, you might not get the intended effect of this medicine.
- Do not inject Ozempic which has been exposed to direct sunlight. If you do that, you might not get the intended effect of this medicine.
- Do not expose your pen to dust, dirt or liquid.
- Do not wash, soak or lubricate your pen. It may be cleaned with a mild detergent on a moistened cloth.
- Do not drop your pen or knock it against hard surfaces. If you drop it or suspect a problem, attach a new needle and check the flow before you inject.
- Do not try to refill your pen. Once empty, it must be disposed of.
- Do not try to repair your pen or pull it apart.

Ozempic contains the active substance semaglutide. It helps your body reduce your blood sugar level only when blood sugar is too high and can help prevent heart disease in patients with type 2 diabetes mellitus (T2DM). It also helps to slow down deterioration of kidney function in patients with T2DM by a mechanism beyond blood glucose lowering.

Ozempic is used to treat adults (aged 18 years and older) with T2DM when diet and exercise is not enough:
- on its own – when you cannot use metformin (another diabetes medicine) or
- with other medicines for diabetes – when they are not enough to control your blood sugar levels.
These may be medicines you take by mouth or inject such as insulin.

It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or nurse.

Do not use Ozempic
- if you are allergic to semaglutide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using this medicine.

This medicine is not the same as insulin and you should not use it if:
- you develop diabetic ketoacidosis – a complication of diabetes with high blood sugar, breathing difficulty, confusion, excessive thirst, a sweet smell to the breath or a sweet or metallic taste in the mouth.

Ozempic is not an insulin and should therefore not be used as a substitute for insulin.
If you know that you are due to have surgery where you will be under anesthesia (sleeping), please tell your doctor that you are taking Ozempic.

Stomach and gut problems and dehydration

During treatment with this medicine, you may feel sick (nausea) or be sick (vomiting), or have diarrhoea. These side effects can cause dehydration (loss of fluids). It is important that you drink plenty of fluids to prevent dehydration. This is especially important if you have kidney problems. Talk to your doctor if you have any questions or concerns.

Severe and on-going stomach pain which could be due to acute pancreatitis

If you have severe and on-going pain in the stomach area – see a doctor straight away as this could be a sign of acute pancreatitis (inflamed pancreas). Please see section 4 for the warning signs of inflamed pancreas.

Low blood sugar (hypoglycaemia)

Combining a sulfonylurea or an insulin with this medicine might increase the risk of getting low blood sugar levels (hypoglycaemia). Please see section 4 for the warning signs of low blood sugar levels.
Your doctor may ask you to test your blood sugar levels. This will help your doctor decide if the dose of the sulfonylurea or insulin needs to be changed to reduce the risk of low blood sugar.

Diabetic eye disease (retinopathy)

If you have diabetic eye disease and are using insulin, this medicine may lead to a worsening of your vision, and this may require treatment. Tell your doctor if you have diabetic eye disease or if you experience eye problems during treatment with this medicine. In case you have potentially unstable diabetic eye disease, it is not recommended that you use Ozempic 2 mg.

Sudden changes to your eyesight

If you notice a sudden loss of vision or rapidly worsening eyesight during treatment with this medicine, immediately contact your doctor for advice. This may be caused by a very rare side effect called non- arteritic anterior ischaemic optic neuropathy (NAION) (See section 4: Serious side effects). Your doctor may refer you for an eye examination and you may have to stop treatment with this medicine.

Patients with delayed stomach emptying (gastroparesis)

If you have slow (delayed) stomach emptying (called gastroparesis), use of Ozempic® may lead to serious or severe gastrointestinal adverse events. Talk to your doctor before using Ozempic®.

Children and adolescents
This medicine is not recommended in children and adolescents aged under 18 years as the safety and efficacy in this age group have not yet been established.

Other medicines and Ozempic
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including herbal medicines or other medicines you bought without a prescription.

In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the following:
- Warfarin or other similar medicines taken by mouth to reduce blood clotting (oral anti- coagulants). You may need frequent blood tests to check how quickly your blood clots.
- If you are using insulin, your doctor will tell you how to reduce the dose of insulin and will recommend you to monitor your blood sugar more frequently, in order to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin).

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you might be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

This medicine should not be used during pregnancy, as it is not known if it affects an unborn baby.
Therefore, use of contraception is recommended while using this medicine. If you wish to become pregnant, discuss how to change your treatment with your doctor as you should stop using this medicine at least 2 months in advance. If you become pregnant while using this medicine, talk to your doctor right away, as your treatment will need to be changed.

Do not use this medicine if you are breast-feeding, as it is unknown if it passes into breast milk.

Driving and using machines
Ozempic is unlikely to affect your ability to drive and use machines. If you use this medicine in combination with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur which may reduce your ability to concentrate. Do not drive or use machines if you get any signs of low blood sugar. See section 2, ‘Warnings and precautions’ for information on increased risk of low blood sugar and section 4 for the warning signs of low blood sugar. Talk to your doctor for further information.

Sodium content
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much to use
- The starting dose is 0.25 mg once a week for four weeks.
- After four weeks your doctor will increase your dose to 0.5 mg once a week.
- Your doctor may increase your dose to 1 mg once a week if your blood sugar is not controlled well enough with a dose of 0.5 mg once a week.
- Your doctor may increase your dose to 2 mg once a week if your blood sugar is not controlled well enough with a dose of 1 mg once a week.

Do not change your dose unless your doctor has told you to.

How Ozempic is given
Ozempic is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or muscle.
- The best places to give the injection are the front of your thighs, the front of your waist (abdomen), or your upper arm.
- Before you use the pen for the first time, your doctor or nurse will show you how to use it.
Detailed instructions for use are on the other side of this package leaflet.

When to use Ozempic
- You should use this medicine once a week on the same day each week if possible.
- You can give yourself the injection at any time of the day – regardless of meals.

To help you remember to inject this medicine once a week only, it is recommended to note the chosen weekday (e.g. Wednesday) on the carton and to write the date on the carton every time you have injected it.

If necessary you can change the day of your weekly injection of this medicine as long as it has been at least 3 days since your last injection of it. After selecting a new dosing day, continue with once a week dosing.

If you use more Ozempic than you should
If you use more Ozempic than you should, talk to your doctor straight away. You may get side effects such as feeling sick (nausea).

If you forget to use Ozempic
If you forgot to inject a dose and:
- it is 5 days or less since you should have used Ozempic, use it as soon as you remember. Then inject your next dose as usual on your scheduled day.
- it is more than 5 days since you should have used Ozempic, skip the missed dose. Then inject your next dose as usual on your scheduled day.
Do not use a double dose to make up for a forgotten dose.

If you stop using Ozempic
Do not stop using this medicine without talking to your doctor. If you stop using it, your blood sugar levels may increase.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Common (may affect up to 1 in 10 people)
- Complications of diabetic eye disease (retinopathy) – you should tell your doctor if you get eye problems, such as changes in vision, during treatment with this medicine.

Uncommon (may affect up to 1 in 100 people)
- Inflamed pancreas (acute pancreatitis) which could cause severe pain in the stomach and back which does not go away. You should see a doctor immediately if you experience such symptoms.

Rare (may affect up to 1 in 1 000 people)
- Severe allergic reactions (anaphylactic reactions, angioedema). You must get immediate medical help and inform your doctor straight away if you get symptoms such as breathing problems, swelling of face, lips, tongue and/or throat with difficulty swallowing and a fast heartbeat.

Very Rare (may affect up to 1 in 10 000 people)
• A medical condition of the eye called non-arteritic anterior ischaemic optic neuropathy (NAION), which may cause loss of vision to one of your eyes without any pain. You should immediately contact your doctor if you notice sudden or gradually worsening eyesight (see section 2: “Sudden changes to your eyesight”.

Not known (frequency cannot be estimated from the available data)
- Bowel obstruction. A severe form of constipation with additional symptoms such as stomach ache, bloating, vomiting etc.

Other side effects

Very common (may affect more than 1 in 10 people)
- Feeling sick (nausea) – this usually goes away over time
- Diarrhoea – this usually goes away over time
- Low blood sugar (hypoglycaemia) when this medicine is used with medicines that contain a sulfonylurea or insulin.

Common (may affect up to 1 in 10 people)
- Being sick (vomiting)
- Low blood sugar (hypoglycaemia) when this medicine is used with oral diabetes medicine other than sulfonylurea or insulin.

The warning signs of low blood sugar may come on suddenly. They can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking.
Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs.
Low blood sugar is more likely to happen if you also take a sulfonylurea or insulin. Your doctor may reduce your dose of these medicines before you start using this medicine.

• Indigestion
• Inflamed stomach (‘gastritis’) – the signs include stomach ache, feeling sick (nausea) or being sick (vomiting)
• Reflux or heartburn – also called ‘gastro-esophageal reflux disease’ (GERD)
• Stomach pain
• Bloating of the stomach
• Constipation
• Burping
• Gall stones
• Dizziness
• Tiredness
• Weight loss
• Less appetite
• Gas (flatulence)
• Increase of pancreatic enzymes (such as lipase and amylase)
• Headache.

Uncommon (may affect up to 1 in 100 people)
- Change in the way food or drink tastes
- Fast pulse
- Injection site reactions – such as bruising, pain, irritation, itching and rash
- Allergic reactions like rash, itching or hives
• A delay in the emptying of the stomach.

Not known (frequency cannot be estimated from the available data)
- Change in skin sensation.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the pen label and carton after ’EXP’.
The expiry date refers to the last day of that month.

Before opening:

Store in a refrigerator (2 °C–8 °C). Do not freeze. Keep away from the cooling element. Keep the pen cap on in order to protect from light.

After first opening:

Ozempic 1 mg (4 dose pen)
- You can keep the pen for 6 weeks when stored at a temperature below 30 °C or in a refrigerator (2 °C–8 °C) away from the cooling element. Do not freeze Ozempic and do not use it if it has been frozen.

Ozempic 1 mg (8 dose pen)
- You can keep the pen for 8 weeks when stored at a temperature below 30 °C or in a refrigerator (2 °C–8 °C) away from the cooling element. Do not freeze Ozempic and do not use it if it has been frozen.

• When you are not using the pen, keep the pen cap on in order to protect from light.

Do not use this medicine if you notice that the solution is not clear and colourless or almost colourless.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Ozempic contains
- The active substance is semaglutide.
- Ozempic 4 dose pen

• One ml solution for injection contains 1.34 mg semaglutide. One pre-filled pen contains 4 mg semaglutide in 3 ml solution. Each dose contains 1 mg of semaglutide in 0.74 ml.
• Ozempic 8 dose pen

• One ml solution for injection contains 2.68 mg semaglutide. One pre-filled pen contains 8 mg semaglutide in 3 ml solution. Each dose contains 1 mg of semaglutide in 0.37 ml.
• The other ingredients are: disodium phosphate dihydrate, propylene glycol, phenol, water for injections, sodium hydroxide/hydrochloric acid (for pH adjustment). See also section 2, ‘Sodium content’.

What Ozempic looks like and contents of the pack
Ozempic is a clear and colourless or almost colourless solution for injection in a pre-filled pen.
Each pre-filled pen contains 3 ml solution, delivering 4 doses of 1 mg.
Each pre-filled pen contains 3 ml of solution, delivering 8 doses of 1 mg.

Ozempic 1 mg solution for injection is available in the following pack sizes:
1 pen and 4 disposable NovoFine Plus needles.
1 pen and 8 disposable NovoFine Plus needles.
3 pens and 12 disposable NovoFine Plus needles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

Novo Nordisk Production SAS
45, Avenue d’Orléans
28000 Chartres
France

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.

Instructions for use

Ozempic 1 mg solution for injection in pre-filled pen delivering 4 doses semaglutide

Instructions on how to use Ozempic 1 mg solution for injection in pre-filled pen Please read these instructions carefully before using your Ozempic pre-filled pen.
Talk to your doctor, nurse or pharmacist about how to inject
Ozempic correctly.
Start by checking your pen to make sure that it contains
Ozempic 1 mg, then look at the illustrations below to get to know the different parts of your pen and needle.
If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help.
Get help from a person with good eyesight who knows how to use the Ozempic pre-filled pen.
Your pen is a pre-filled dial-a-dose pen. It contains 4 mg of semaglutide, and you can only select doses of 1 mg. One unused pen contains four doses of 1 mg.

Use the table inside the lid of the carton to keep track of how many injections you have taken and when you took the injections.

Your pen is designed to be used with 30G, 31G, and 32G disposable needles up to a length of 8 mm.
NovoFine Plus needles are included in the pack.
Ozempic pre-filled pen and needle (example)
Pen cap
Outer needle cap
Inner needle cap
Needle
Paper tab
Pen window
Pen label
Dose counter
Dose pointer
Dose selector
Dose button
Flow check symbol

Important information
Pay special attention to these notes, as they are important for safe use of the pen.
1. Prepare your pen with a new needle

- Check the name and coloured label of your pen, to make sure that it contains Ozempic 1 mg. This is especially important if you take more than one type of injectable medicine. Using the wrong medicine could be harmful to your health.
- Pull off the pen cap.
A
- Check that the solution in your pen is clear and colourless. Look through the pen window. If the solution looks cloudy or coloured, do not use the pen.
B
- Take a new needle.
Check the paper tab and the outer needle cap for damages that could affect sterility. If any damage is seen use a new needle.
- Tear off the paper tab.
C
Make sure to attach the needle correctly.

- Push the needle straight onto the pen.
- Turn until it is on tight.
D
The needle is covered by two caps. You must remove both caps. If you forget to remove both caps, you will not inject any solution.

- Pull off the outer needle cap and keep it for later. You will need it after the injection, to safely remove the needle from the pen.
E

• Pull off the inner needle cap and throw it away. If you try to put it back on, you may accidentally stick yourself with the needle.

A drop of solution may appear at the needle tip. This is normal, but you must still check the flow, if you use a new pen for the first time. See step 2 ‘Check the flow with each new pen’.
Do not attach a new needle to your pen until you are ready to take your injection.
F

Always use a new needle for each injection.

This may prevent blocked needles, contamination, infection and inaccurate dosing.

Never use a bent or damaged needle.
2. Check the flow with each new pen
- If your pen is already in use, go to step 3 ‘Select your dose’. Only check the flow before your first injection with each new pen.

- Turn the dose selector to the flow check symbol (
) right past ‘0’. Make sure the flow check symbol lines up with the pointer.
A
Flow check symbol selected

- Hold the pen with the needle pointing up.
Press and hold in the dose button until the dose counter returns to ‘0’. The ‘0’ must line up with the dose pointer.

A drop of solution should appear at the needle tip.
B
A small drop may remain at the needle tip, but it will not be injected.
If no drop appears, repeat step 2 ‘Check the flow with each new pen’ up to 6 times. If there is still no drop, change the needle and repeat step 2 ‘Check the flow with each new pen’ once more.
Dispose of the pen and use a new one if a drop of solution still does not appear.

Always make sure that a drop appears at the needle tip before you use a new pen for the first time.
This makes sure that the solution flows.
If no drop appears, you will not inject any medicine, even though the dose counter may move. This may indicate a blocked or damaged needle.
If you do not check the flow before your first injection with each new pen, you may not get the prescribed dose and the intended effect of Ozempic.
3. Select your dose
- Turn the dose selector to select 1 mg.

Keep turning until the dose counter stops and shows 1 mg.
1 mg selected
A
Only the dose counter and dose pointer will show that 1 mg has been selected.
You can only select 1 mg per dose. When your pen contains less than 1 mg, the dose counter stops before 1 is shown.
The dose selector clicks differently when turned forwards, backwards or past 1 mg. Do not count the pen clicks.
Always use the dose counter and the dose pointer to see that 1 mg has been selected before injecting this medicine.
Do not count the pen clicks
Only doses of 1 mg must be selected with the dose selector. 1 mg must line up precisely with the dose pointer to ensure that you get a correct dose.

How much solution is left
- To see how much solution is left, use the dose counter:
Turn the dose selector until the dose counter stops.

If it shows 1, at least 1 mg is left in your pen.
If the dose counter stops before 1 mg, there is not enough solution left for a full dose of 1 mg.
A
Dose counter stopped:
1 mg left

If there is not enough solution left in your pen for a full dose, do not use it. Use a new Ozempic pen.

4. Inject your dose
- Insert the needle into your skin as your doctor or nurse has shown you.
- Make sure you can see the dose counter. Do not cover it with your fingers. This could interrupt the injection.
A
- Press and hold down the dose button. Watch as the dose counter returns to ‘0’. The ‘0’ must line up with the dose pointer. You may then hear or feel a click.

- Continue pressing the dose button while keeping the needle in your skin.
B
- Count slowly to 6, while keeping the dose button pressed.
- If the needle is removed earlier, you may see a stream of solution coming from the needle tip. If so, the full dose will not be delivered.
C
1-2-3-4-5-6
Count slowly:
- Remove the needle from your skin. You can then release the dose button.
If blood appears at the injection site, press lightly.
D
You may see a drop of solution at the needle tip after injecting. This is normal and does not affect your dose.

Always watch the dose counter to know how many mg you inject. Hold the dose button down until the dose counter returns to ‘0’.

How to identify a blocked or damaged needle
- If ‘0’ does not appear in the dose counter after continuously pressing the dose button, you may have used a blocked or damaged needle.
- In this case, you have not received any medicine – even though the dose counter has moved from the original dose that you have set.

How to handle a blocked needle
Change the needle as described in step 5 ‘After your injection’ and repeat all steps starting with step 1 ‘Prepare your pen with a new needle’. Make sure you select the full dose you need.

Never touch the dose counter when you inject. This can interrupt the injection.
5. After your injection
Always dispose of the needle after each injection to ensure convenient injections and prevent blocked needles.
If the needle is blocked, you will not inject any medicine.

- Lead the needle tip into the outer needle cap on a flat surface without touching the needle or the outer needle cap.
A

- Once the needle is covered, carefully push the outer needle cap completely on.
- Unscrew the needle and dispose of it carefully as instructed by your doctor, nurse, pharmacist or local authorities.
B
- Put the pen cap on your pen after each use to protect the solution from light.
C

When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist or local authorities.

Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.

Always remove the needle from your pen immediately after each injection.

This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.

Further important information
- Always keep your pen and needles out of the sight and reach of others, especially children.
- Never share your pen or your needles with other people.
- Caregivers must be very careful when handling used needles to prevent needle injury and cross- infection.
Caring for your pen
Treat your pen with care. Rough handling or misuse may cause inaccurate dosing. If this happens you might not get the intended effect of this medicine.
- Do not leave the pen in a car or another place where it can get too hot or too cold.
- Do not inject Ozempic which has been frozen. If you do that, you might not get the intended effect of this medicine.
- Do not inject Ozempic which has been exposed to direct sunlight. If you do that, you might not get the intended effect of this medicine.
- Do not expose your pen to dust, dirt or liquid.
- Do not wash, soak or lubricate your pen. It may be cleaned with a mild detergent on a moistened cloth.
- Do not drop your pen or knock it against hard surfaces. If you drop it or suspect a problem, attach a new needle and check the flow before you inject.
- Do not try to refill your pen. Once empty, it must be disposed of.
- Do not try to repair your pen or pull it apart.

Instructions for use

Ozempic 1 mg solution for injection in pre-filled pen delivering 8 doses semaglutide

Instructions on how to use Ozempic 1 mg solution for injection in pre-filled pen Please read these instructions carefully before using your Ozempic pre-filled pen. Talk to your doctor, nurse or pharmacist about how to inject Ozempic correctly.
Start by checking your pen to make sure that it contains
Ozempic 1 mg, then look at the illustrations below to get to know the different parts of your pen and needle.
If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help.
Get help from a person with good eyesight who knows how to use the Ozempic pre-filled pen.

Your pen is a pre-filled dial-a-dose pen. It contains 8 mg of semaglutide, and you can only select doses of 1 mg. One unused pen contains eight doses of 1 mg.

After having injected the intended doses, there will still be solution left in the pen. The pen should be disposed of.

Use the table inside the lid of the carton to keep track of how many injections you have taken and when you took the injections.

Your pen is designed to be used with 30G, 31G, and 32G disposable needles up to a length of 8 mm.
NovoFine Plus needles are included in the pack.

Ozempic pre-filled pen and needle (example)
Pen cap
Outer needle cap
Inner needle cap
Needle
Paper tab
Pen window
Pen label
Dose counter
Dose pointer
Dose selector
Dose button
Flow check symbol

Important information
Pay special attention to these notes, as they are important for safe use of the pen.
1. Prepare your pen with a new needle

- Check the name and coloured label of your pen, to make sure that it contains Ozempic 1 mg. This is especially important if you take more than one type of injectable medicine. Using the wrong medicine could be harmful to your health.
- Pull off the pen cap.
A
- Check that the solution in your pen is clear and colourless. Look through the pen window. If the solution looks cloudy or coloured, do not use the pen.
B
- Take a new needle.
Check the paper tab and the outer needle cap for damages that could affect sterility. If any damage is seen use a new needle.
- Tear off the paper tab.

C

Make sure to attach the needle correctly.

- Push the needle straight onto the pen.
- Turn until it is on tight.
D

The needle is covered by two caps. You must remove both caps. If you forget to remove both caps, you will not inject any solution.

- Pull off the outer needle cap and keep it for later. You will need it after the injection, to safely remove the needle from the pen.
E

• Pull off the inner needle cap and throw it away. If you try to put it back on, you may accidentally stick yourself with the needle.

A drop of solution may appear at the needle tip. This is normal, but you must still check the flow, if you use a new pen for the first time. See step 2 ‘Check the flow with each new pen’.
Do not attach a new needle to your pen until you are ready to take your injection.
F

Always use a new needle for each injection.

This may prevent blocked needles, contamination, infection and inaccurate dosing.

Never use a bent or damaged needle.
2. Check the flow with each new pen
- If your pen is already in use, go to step 3 ‘Select your dose’. Only check the flow before your first injection with each new pen.

- Turn the dose selector to the flow check symbol (
) right past ‘0’. Make sure the flow check symbol lines up with the pointer.
A
Flow check symbol selected

• Hold the pen with the needle pointing up.

Press and hold in the dose button until the dose counter returns to ‘0’. The ‘0’ must line up with the dose pointer.

A drop of solution should appear at the needle tip.
B
A small drop may remain at the needle tip, but it will not be injected.
If no drop appears, repeat step 2 ‘Check the flow with each new pen’ up to 6 times. If there is still no drop, change the needle and repeat step 2 ‘Check the flow with each new pen’ once more.
Dispose of the pen and use a new one if a drop of solution still does not appear.

Always make sure that a drop appears at the needle tip before you use a new pen for the first time.
This makes sure that the solution flows.

If no drop appears, you will not inject any medicine even though the dose counter may move. This may indicate a blocked or damaged needle.

If you do not check the flow before your first injection with each new pen, you may not get the prescribed dose and the intended effect of Ozempic.
3. Select your dose
- Turn the dose selector to select 1 mg.

Keep turning until the dose counter stops and shows 1 mg.
1 mg selected
A
Only the dose counter and dose pointer will show that 1 mg has been selected.
You can only select 1 mg per dose. When your pen contains less than 1 mg, the dose counter stops before 1 is shown.
The dose selector clicks differently when turned forwards, backwards or past 1 mg. Do not count the pen clicks.

Always use the dose counter and the dose pointer to see that 1 mg has been selected before injecting this medicine.

Do not count the pen clicks.

Only doses of 1 mg must be selected with the dose selector. 1 mg must line up precisely with the dose pointer to ensure that you get a correct dose.
How much solution is left
- To see how much solution is left, use the dose counter:
Turn the dose selector until the dose counter stops.

If it shows 1, at least 1 mg is left in your pen.

If the dose counter stops before 1 mg, there is not enough solution left for a full dose of 1 mg.
A
Dose counter stopped:
1 mg left

If there is not enough solution left in your pen for a full dose, do not use it. Use a new Ozempic pen.
4. Inject your dose

- Insert the needle into your skin as your doctor or nurse has shown you.
- Make sure you can see the dose counter. Do not cover it with your fingers. This could interrupt the injection.
A
- Press and hold down the dose button. Watch as the dose counter returns to ‘0’. The ‘0’ must line up with the dose pointer. You may then hear or feel a click.

- Continue pressing the dose button while keeping the needle in your skin.
B
- Count slowly to 6, while keeping the dose button pressed.

- If the needle is removed earlier, you may see a stream of solution coming from the needle tip. If so, the full dose will not be delivered.
C
1-2-3-4-5-6
Count slowly:

• Remove the needle from your skin. You can then release the dose button.

If blood appears at the injection site, press lightly.
D
You may see a drop of solution at the needle tip after injecting. This is normal and does not affect your dose.

Always watch the dose counter to know how many mg you inject. Hold the dose button down until the dose counter returns to ‘0’.

How to identify a blocked or damaged needle
- If ‘0’ does not appear in the dose counter after continuously pressing the dose button, you may have used a blocked or damaged needle.
- In this case, you have not received any medicine – even though the dose counter has moved from the original dose that you have set.

How to handle a blocked needle

Change the needle as described in step 5 ‘After your injection’ and repeat all steps starting with step 1 ‘Prepare your pen with a new needle’. Make sure you select the full dose you need.

Never touch the dose counter when you inject. This can interrupt the injection.
5. After your injection

Always dispose of the needle after each injection to ensure convenient injections and prevent blocked needles.
If the needle is blocked, you will not inject any medicine.

- Lead the needle tip into the outer needle cap on a flat surface without touching the needle or the outer needle cap.
A

- Once the needle is covered, carefully push the outer needle cap completely on.
- Unscrew the needle and dispose of it carefully as instructed by your doctor, nurse, pharmacist or local authorities.
B
- Put the pen cap on your pen after each use to protect the solution from light.
C

When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist or local authorities.

Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.

Always remove the needle from your pen immediately after each injection.

This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.

Further important information
- Always keep your pen and needles out of the sight and reach of others, especially children.
- Never share your pen or your needles with other people.
- Caregivers must be very careful when handling used needles to prevent needle injury and cross- infection.
Caring for your pen
Treat your pen with care. Rough handling or misuse may cause inaccurate dosing. If this happens you might not get the intended effect of this medicine.
- Do not leave the pen in a car or another place where it can get too hot or too cold.
- Do not inject Ozempic which has been frozen. If you do that, you might not get the intended effect of this medicine.
- Do not inject Ozempic which has been exposed to direct sunlight. If you do that, you might not get the intended effect of this medicine.
- Do not expose your pen to dust, dirt or liquid.
- Do not wash, soak or lubricate your pen. It may be cleaned with a mild detergent on a moistened cloth.
- Do not drop your pen or knock it against hard surfaces. If you drop it or suspect a problem, attach a new needle and check the flow before you inject.
- Do not try to refill your pen. Once empty, it must be disposed of.
- Do not try to repair your pen or pull it apart.

Ozempic contains the active substance semaglutide. It helps your body reduce your blood sugar level only when blood sugar is too high and can help prevent heart disease in patients with type 2 diabetes mellitus (T2DM). It also helps to slow down deterioration of kidney function in patients with T2DM by a mechanism beyond blood glucose lowering.

Ozempic is used to treat adults (aged 18 years and older) with T2DM when diet and exercise is not enough:
- on its own – when you cannot use metformin (another diabetes medicine) or
- with other medicines for diabetes – when they are not enough to control your blood sugar levels.
These may be medicines you take by mouth or inject such as insulin.

It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or nurse.

Do not use Ozempic
- if you are allergic to semaglutide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using this medicine.

This medicine is not the same as insulin and you should not use it if:
- you develop diabetic ketoacidosis – a complication of diabetes with high blood sugar, breathing difficulty, confusion, excessive thirst, a sweet smell to the breath or a sweet or metallic taste in the mouth.

Ozempic is not an insulin and should therefore not be used as a substitute for insulin.
If you know that you are due to have surgery where you will be under anesthesia (sleeping), please tell your doctor that you are taking Ozempic.

Stomach and gut problems and dehydration

During treatment with this medicine, you may feel sick (nausea) or be sick (vomiting), or have diarrhoea. These side effects can cause dehydration (loss of fluids). It is important that you drink plenty of fluids to prevent dehydration. This is especially important if you have kidney problems. Talk to your doctor if you have any questions or concerns.

Severe and on-going stomach pain which could be due to acute pancreatitis

If you have severe and on-going pain in the stomach area – see a doctor straight away as this could be a sign of acute pancreatitis (inflamed pancreas). Please see section 4 for the warning signs of inflamed pancreas.

Low blood sugar (hypoglycaemia)

Combining a sulfonylurea or an insulin with this medicine might increase the risk of getting low blood sugar levels (hypoglycaemia). Please see section 4 for the warning signs of low blood sugar levels.
Your doctor may ask you to test your blood sugar levels. This will help your doctor decide if the dose of the sulfonylurea or insulin needs to be changed to reduce the risk of low blood sugar.

Diabetic eye disease (retinopathy)

If you have diabetic eye disease and are using insulin, this medicine may lead to a worsening of your vision, and this may require treatment. Tell your doctor if you have diabetic eye disease or if you experience eye problems during treatment with this medicine. In case you have potentially unstable diabetic eye disease, it is not recommended that you use Ozempic 2 mg.

Sudden changes to your eyesight
If you notice a sudden loss of vision or rapidly worsening eyesight during treatment with this medicine, immediately contact your doctor for advice. This may be caused by a very rare side effect called non- arteritic anterior ischaemic optic neuropathy (NAION) (See section 4: Serious side effects). Your doctor may refer you for an eye examination and you may have to stop treatment with this medicine.

Patients with delayed stomach emptying (gastroparesis)

If you have slow (delayed) stomach emptying (called gastroparesis), use of Ozempic® may lead to serious or severe gastrointestinal adverse events. Talk to your doctor before using Ozempic®.

Children and adolescents
This medicine is not recommended in children and adolescents aged under 18 years as the safety and efficacy in this age group have not yet been established.

Other medicines and Ozempic
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including herbal medicines or other medicines you bought without a prescription.

In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the following:
- Warfarin or other similar medicines taken by mouth to reduce blood clotting (oral anti- coagulants). You may need frequent blood tests to check how quickly your blood clots.

• If you are using insulin, your doctor will tell you how to reduce the dose of insulin and will recommend you to monitor your blood sugar more frequently, in order to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin).

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you might be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

This medicine should not be used during pregnancy, as it is not known if it affects an unborn baby.
Therefore, use of contraception it recommended while using this medicine. If you wish to become pregnant, discuss how to change your treatment with your doctor as you should stop using this medicine at least 2 months in advance. If you become pregnant while using this medicine, talk to your doctor right away, as your treatment will need to be changed.

Do not use this medicine if you are breast-feeding, as it is unknown if it passes into breast milk.

Driving and using machines
Ozempic is unlikely to affect your ability to drive and use machines. If you use this medicine in combination with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur which may reduce your ability to concentrate. Do not drive or use machines if you get any signs of low blood sugar. See section 2, ‘Warnings and precautions’ for information on increased risk of low blood sugar and section 4 for the warning signs of low blood sugar. Talk to your doctor for further information.

Sodium content
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much to use
- The starting dose is 0.25 mg once a week for four weeks.
- After four weeks your doctor will increase your dose to 0.5 mg once a week.
- Your doctor may increase your dose to 1 mg once a week if your blood sugar is not controlled well enough with a dose of 0.5 mg once a week.
- Your doctor may increase your dose to 2 mg once a week if your blood sugar is not controlled well enough with a dose of 1 mg once a week.

Do not change your dose unless your doctor has told you to.

How Ozempic is given
Ozempic is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or muscle.
- The best places to give the injection are the front of your thighs, the front of your waist (abdomen), or your upper arm.
- Before you use the pen for the first time, your doctor or nurse will show you how to use it.
Detailed instructions for use are on the other side of this package leaflet.

When to use Ozempic
- You should use this medicine once a week on the same day each week if possible.
- You can give yourself the injection at any time of the day – regardless of meals.

To help you remember to inject this medicine once a week only, it is recommended to note the chosen weekday (e.g. Wednesday) on the carton and to write the date on the carton every time you have injected it.

If necessary you can change the day of your weekly injection of this medicine as long as it has been at least 3 days since your last injection of it. After selecting a new dosing day, continue with once a week dosing.

If you use more Ozempic than you should
If you use more Ozempic than you should, talk to your doctor straight away. You may get side effects such as feeling sick (nausea).

If you forget to use Ozempic
If you forgot to inject a dose and:
- it is 5 days or less since you should have used Ozempic, use it as soon as you remember. Then inject your next dose as usual on your scheduled day.
- it is more than 5 days since you should have used Ozempic, skip the missed dose. Then inject your next dose as usual on your scheduled day.
Do not use a double dose to make up for a forgotten dose.

If you stop using Ozempic
Do not stop using this medicine without talking to your doctor. If you stop using it, your blood sugar levels may increase.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Common (may affect up to 1 in 10 people)
- Complications of diabetic eye disease (retinopathy) – you should tell your doctor if you get eye problems, such as changes in vision, during treatment with this medicine.

Uncommon (may affect up to 1 in 100 people)
- Inflamed pancreas (acute pancreatitis) which could cause severe pain in the stomach and back which does not go away. You should see a doctor immediately if you experience such symptoms.

Rare (may affect up to 1 in 1 000 people)
- Severe allergic reactions (anaphylactic reactions, angioedema). You must get immediate medical help and inform your doctor straight away if you get symptoms such as breathing problems, swelling of face, lips, tongue and/or throat with difficulty swallowing and a fast heartbeat.

Very Rare (may affect up to 1 in 10 000 people)
• A medical condition of the eye called non-arteritic anterior ischaemic optic neuropathy (NAION), which may cause loss of vision to one of your eyes without any pain. You should immediately contact your doctor if you notice sudden or gradually worsening eyesight (see section 2: “Sudden changes to your eyesight”.

Not known (frequency cannot be estimated from the available data)
- Bowel obstruction. A severe form of constipation with additional symptoms such as stomach ache, bloating, vomiting etc.

Other side effects

Very common (may affect more than 1 in 10 people)
- Feeling sick (nausea) – this usually goes away over time
- Diarrhoea – this usually goes away over time
- Low blood sugar (hypoglycaemia) when this medicine is used with medicines that contain a sulfonylurea or insulin.

Common (may affect up to 1 in 10 people)
- Being sick (vomiting)
- Low blood sugar (hypoglycaemia) when this medicine is used with oral diabetes medicine other than sulfonylurea or insulin.

The warning signs of low blood sugar may come on suddenly. They can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking.
Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs.
Low blood sugar is more likely to happen if you also take a sulfonylurea or insulin. Your doctor may reduce your dose of these medicines before you start using this medicine.

• Indigestion
• Inflamed stomach (‘gastritis’) – the signs include stomach ache, feeling sick (nausea) or being sick (vomiting)
• Reflux or heartburn – also called ‘gastro-esophageal reflux disease’ (GERD)
• Stomach pain
• Bloating of the stomach
• Constipation
• Burping
• Gall stones
• Dizziness
• Tiredness
• Weight loss
• Less appetite
• Gas (flatulence)
• Increase of pancreatic enzymes (such as lipase and amylase)
• Headache.

Uncommon (may affect up to 1 in 100 people)
- Change in the way food or drink tastes
- Fast pulse
- Injection site reactions – such as bruising, pain, irritation, itching and rash
- Allergic reactions like rash, itching or hives
- A delay in the emptying of the stomach.

Not known (frequency cannot be estimated from the available data)
- Change in skin sensation.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting

system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the pen label and carton after ’EXP’.
The expiry date refers to the last day of that month.

Before opening:

Store in a refrigerator (2 °C–8 °C). Do not freeze. Keep away from the cooling element. Keep the pen cap on in order to protect from light.

After first opening:

• You can keep the pen for 6 weeks when stored at a temperature below 30 °C or in a refrigerator (2 °C–8 °C) away from the cooling element. Do not freeze Ozempic and do not use it if it has been frozen.
• When you are not using the pen, keep the pen cap on in order to protect from light.

Do not use this medicine if you notice that the solution is not clear and colourless or almost colourless.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Ozempic contains
- The active substance is semaglutide. One ml solution for injection contains 2.68 mg semaglutide. One pre-filled pen contains 8 mg semaglutide in 3 ml solution. Each dose contains 2 mg of semaglutide in 0.74 ml.
- The other ingredients are: disodium phosphate dihydrate, propylene glycol, phenol, water for injections, sodium hydroxide/hydrochloric acid (for pH adjustment). See also section 2, ‘Sodium content’.

What Ozempic looks like and contents of the pack
Ozempic is a clear and colourless or almost colourless solution for injection in a pre-filled pen.
Each pre-filled pen contains 3 ml solution, delivering 4 doses of 2 mg.

Ozempic 2 mg solution for injection is available in the following pack sizes:
1 pen and 4 disposable NovoFine Plus needles.
3 pens and 12 disposable NovoFine Plus needles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.

Instructions for use

Ozempic 2 mg solution for injection in pre-filled pen semaglutide

Instructions on how to use Ozempic 2 mg solution for injection in pre-filled pen Please read these instructions carefully before using your Ozempic pre-filled pen. Talk to your doctor, nurse or pharmacist about how to inject Ozempic correctly.

Start by checking your pen to make sure that it contains
Ozempic 2 mg, then look at the illustrations below to get to know the different parts of your pen and needle.
If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help.
Get help from a person with good eyesight who knows how to use the Ozempic pre-filled pen.
Your pen is a pre-filled dial-a-dose pen. It contains 8 mg of semaglutide, and you can only select doses of 2 mg. One unused pen contains four doses of 2 mg.

Use the table inside the lid of the carton to keep track of how many injections you have taken and when you took the injections.

Your pen is designed to be used with 30G, 31G, and 32G disposable needles up to a length of 8 mm.
NovoFine Plus needles are included in the pack.

Ozempic pre-filled pen and needle (example)
Pen cap
Outer needle cap
Inner needle cap
Needle
Paper tab
Pen window
Pen label
Dose counter
Dose pointer
Dose selector
Dose button
Flow check symbol

Important information
Pay special attention to these notes, as they are important for safe use of the pen.
1. Prepare your pen with a new needle

- Check the name and coloured label of your pen, to make sure that it contains Ozempic 2 mg. This is especially important if you take more than one type of injectable medicine. Using the wrong medicine could be harmful to your health.
- Pull off the pen cap.
A
- Check that the solution in your pen is clear and colourless. Look through the pen window. If the solution looks cloudy or coloured, do not use the pen.
B
- Take a new needle.
Check the paper tab and the outer needle cap for damages that could affect sterility. If any damage is seen use a new needle.
- Tear off the paper tab.

C

Make sure to attach the needle correctly.

- Push the needle straight onto the pen.
- Turn until it is on tight.
D
The needle is covered by two caps. You must remove both caps. If you forget to remove both caps, you will not inject any solution.

- Pull off the outer needle cap and keep it for later. You will need it after the injection, to safely remove the needle from the pen.
E

• Pull off the inner needle cap and throw it away. If you try to put it back on, you may accidentally stick yourself with the needle.

A drop of solution may appear at the needle tip. This is normal, but you must still check the flow, if you use a new pen for the first time. See step 2 ‘Check the flow with each new pen’.
Do not attach a new needle to your pen until you are ready to take your injection.
F

Always use a new needle for each injection.

This may prevent blocked needles, contamination, infection and inaccurate dosing.

Never use a bent or damaged needle.
2. Check the flow with each new pen
- If your pen is already in use, go to step 3 ‘Select your dose’. Only check the flow before your first injection with each new pen.
- Turn the dose selector to the flow check symbol (
) right past ‘0’. Make sure the flow check symbol lines up with the pointer.
A
Flow check symbol selected

• Hold the pen with the needle pointing up.

Press and hold in the dose button until the dose counter returns to ‘0’. The ‘0’ must line up with the dose pointer.

A drop of solution should appear at the needle tip.
B
A small drop may remain at the needle tip, but it will not be injected.
If no drop appears, repeat step 2 ‘Check the flow with each new pen’ up to 6 times. If there is still no drop, change the needle and repeat step 2 ‘Check the flow with each new pen’ once more.
Dispose of the pen and use a new one if a drop of solution still does not appear.

Always make sure that a drop appears at the needle tip before you use a new pen for the first time.
This makes sure that the solution flows.

If no drop appears, you will not inject any medicine, even though the dose counter may move. This may indicate a blocked or damaged needle.

If you do not check the flow before your first injection with each new pen, you may not get the prescribed dose and the intended effect of Ozempic.
3. Select your dose
- Turn the dose selector to select 2 mg.

Keep turning until the dose counter stops and shows 2 mg.
2 mg selected
A
Only the dose counter and dose pointer will show that 2 mg has been selected.
You can only select 2 mg per dose. When your pen contains less than 2 mg, the dose counter stops before 2 is shown.
The dose selector clicks differently when turned forwards, backwards or past 2 mg. Do not count the pen clicks.

Always use the dose counter and the dose pointer to see that 2 mg has been selected before injecting this medicine.

Do not count the pen clicks.

Only doses of 2 mg must be selected with the dose selector. 2 mg must line up precisely with the dose pointer to ensure that you get a correct dose.
How much solution is left
- To see how much solution is left, use the dose counter:
Turn the dose selector until the dose counter stops.

If it shows 2, at least 2 mg is left in your pen.

If the dose counter stops before 2 mg, there is not enough solution left for a full dose of 2 mg.
A
Dose counter stopped:
2 mg left

If there is not enough solution left in your pen for a full dose, do not use it. Use a new Ozempic pen.

4. Inject your dose
- Insert the needle into your skin as your doctor or nurse has shown you.
- Make sure you can see the dose counter. Do not cover it with your fingers. This could interrupt the injection.
A
- Press and hold down the dose button. Watch as the dose counter returns to ‘0’. The ‘0’ must line up with the dose pointer. You may then hear or feel a click.

- Continue pressing the dose button while keeping the needle in your skin.
B

• Count slowly to 6, while keeping the dose button pressed.

- If the needle is removed earlier, you may see a stream of solution coming from the needle tip. If so, the full dose will not be delivered.
C
1-2-3-4-5-6
Count slowly:
- Remove the needle from your skin. You can then release the dose button.
If blood appears at the injection site, press lightly.
D

You may see a drop of solution at the needle tip after injecting. This is normal and does not affect your dose.

Always watch the dose counter to know how many mg you inject. Hold the dose button down until the dose counter returns to ‘0’.

How to identify a blocked or damaged needle
- If ‘0’ does not appear in the dose counter after continuously pressing the dose button, you may have used a blocked or damaged needle.
- In this case, you have not received any medicine – even though the dose counter has moved from the original dose that you have set.

How to handle a blocked needle

Change the needle as described in step 5 ‘After your injection’ and repeat all steps starting with step 1 ‘Prepare your pen with a new needle’. Make sure you select the full dose you need.

Never touch the dose counter when you inject. This can interrupt the injection.
5. After your injection
Always dispose of the needle after each injection to ensure convenient injections and prevent blocked needles. If the needle is blocked, you will not inject any medicine.

- Lead the needle tip into the outer needle cap on a flat surface without touching the needle or the outer needle cap.
A

- Once the needle is covered, carefully push the outer needle cap completely on.
- Unscrew the needle and dispose of it carefully as instructed by your doctor, nurse, pharmacist or local authorities.
B
- Put the pen cap on your pen after each use to protect the solution from light.
C
When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist or local authorities.

Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.

Always remove the needle from your pen immediately after each injection.

This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.

Further important information
- Always keep your pen and needles out of the sight and reach of others, especially children.
- Never share your pen or your needles with other people.
- Caregivers must be very careful when handling used needles to prevent needle injury and cross- infection.
Caring for your pen
Treat your pen with care. Rough handling or misuse may cause inaccurate dosing. If this happens you might not get the intended effect of this medicine.
- Do not leave the pen in a car or another place where it can get too hot or too cold.
- Do not inject Ozempic which has been frozen. If you do that, you might not get the intended effect of this medicine.
- Do not inject Ozempic which has been exposed to direct sunlight. If you do that, you might not get the intended effect of this medicine.
- Do not expose your pen to dust, dirt or liquid.
- Do not wash, soak or lubricate your pen. It may be cleaned with a mild detergent on a moistened cloth.
- Do not drop your pen or knock it against hard surfaces. If you drop it or suspect a problem, attach a new needle and check the flow before you inject.
- Do not try to refill your pen. Once empty, it must be disposed of.
- Do not try to repair your pen or pull it apart.

• Open the carton.
• Gently take out one syringe by holding the glass barrel.
• Check the syringe label. Confirm you have the dose prescribed by your doctor.

Do not hold or touch the syringe by the plunger rod or needle cap.

Keep the needle cap on, until you are ready to inject.

Medicine
EXP MM-YYYY

• Look through the glass barrel. Only use the syringe if the medicine appears as described in section 5 on the other side of this leaflet.

The expiry date can be found on the back side of the syringe label.

It is normal to see air bubbles. Do not try to remove bubbles.

Do not use the syringe if it appears to have been used, dropped, damaged or broken.

Stomach area or thighs
Back of upper arm
(only with help from someone else)

Inject under the skin of your:
• Stomach area (abdomen) at least 5 cm from the belly button.
• Thighs.
⸰ Back of upper arm (only with help from someone else).

Your doctor will help you choose the injection site that is best for you.

Avoid using the exact same spot as the last time you injected.

Inject your dose

• Pull the needle cap straight off and dispose of it.

You might see drops of medicine from the needle tip. This is normal and does not affect your dose.
Continue with your injection right away.
Do not put the needle cap back on the syringe, to avoid needle stick injuries.

• Gently make a skinfold and fully insert the syringe needle at a 45-degree angle.

You will reach under the skin and not the muscle.

• With a slow and constant pressure, push the plunger rod all the way in until the plunger stops.

When the plunger is at the bottom and the syringe is empty your dose is complete.

7. Remove your syringe

• Remove the needle at a 45-degree angle.

If blood appears at the injection site, press lightly on the area to stop the bleeding, without rubbing.

Dispose of your syringe
Be careful when handling used needles. Dispose of your syringe right away. Find disposal information in section 5 on the other side of this leaflet.

Rybelsus contains the active substance semaglutide. It is a medicine that is used to lower blood sugar levels.

Rybelsus is used to treat adults (aged 18 years and older) with type 2 diabetes when diet and exercise is not enough:
- on its own - when you cannot use metformin (another diabetes medicine) or
- with other medicines for diabetes - when the other medicines are not enough to control your blood sugar levels. These may be medicines you take by mouth or inject such as insulin.

It is important that you continue with your diet and exercise plan as agreed with your doctor, pharmacist or nurse.

What is type 2 diabetes?
Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body makes does not lower your blood sugar the way it should. In some cases, your body can produce too much blood sugar. If your blood sugar increases and remains high over a long period of time, this can lead to harmful effects such as heart problems, kidney disease, eye disorders and poor circulation in your limbs. That is why it is important to keep your blood sugar levels within a normal range.

Do not take Rybelsus
- if you are allergic to semaglutide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Rybelsus.

Traceability
In order to improve the traceability of biological medicinal products, record the name and the lot number (included on the outer cartons and blister) of the medicine you are taking and provide this information when reporting any side effects.

General
This medicine is not the same as insulin and you should not use it if:
- you develop diabetic ketoacidosis. This is a complication of diabetes with high blood sugar, breathing difficulty, confusion, excessive thirst, a sweet smell to the breath or a sweet or metallic taste in the mouth.

If you know that you are due to have surgery where you will be under anaesthesia (sleeping), please tell your doctor that you are taking Rybelsus.

Stomach and gut problems and dehydration
During treatment with this medicine, you may feel sick (nausea) or be sick (vomiting), or have diarrhoea. These side effects can cause dehydration (loss of fluids). It is important that you drink enough fluids to prevent dehydration. This is especially important if you have kidney problems. Talk to your doctor if you have any questions or concerns.

Severe and on-going stomach pain which could be due to an inflamed pancreas
If you have severe and on-going pain in the stomach area - see a doctor straight away as this could be a sign of inflamed pancreas (acute pancreatitis).

Low blood sugar (hypoglycaemia)
Taking a sulfonylurea medicine or insulin with Rybelsus might increase the risk of getting low blood sugar (hypoglycaemia). See section 4 for the warning signs of low blood sugar levels.

Your doctor may ask you to test your blood sugar levels. This will help to decide if the dose of the sulfonylurea or insulin needs to be changed to reduce the risk of low blood sugar.

Diabetic eye disease (retinopathy)
Fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disease.
If you have diabetic eye disease and get eye problems while taking this medicine, talk to your doctor.

Treatment response
If the treatment response with semaglutide is lower than expected, this may be due to low absorption caused by variability in absorption and low absolute bioavailability. You should follow the instructions given in section 3 for optimal effect of semaglutide.

Sudden changes to your eyesight
If you notice a sudden loss of vision or rapidly worsening eyesight during treatment with this medicine, immediately contact your doctor for advice. This may be caused by a very rare side effect called non- arteritic anterior ischaemic optic neuropathy (NAION) (See section 4: Serious side effects). Your doctor may refer you for an eye examination and you may have to stop treatment with this medicine.

Patients with delayed stomach emptying (gastroparesis)
If you have slow (delayed) stomach emptying (called gastroparesis), use of Rybelsus may lead to serious or severe gastrointestinal adverse events. Talk to your doctor before using Rybelsus.

Children and adolescents
This medicine is not recommended in children and adolescents aged under 18 years as the safety and efficacy in this age group have not been established.

Other medicines and Rybelsus
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the following:
- Levothyroxine which is used for thyroid disease. This is because your doctor may need to check your thyroid levels if you are taking Rybelsus together with levothyroxine.
- Warfarin or similar medicines taken by mouth to reduce blood clotting (oral anti-coagulants).
You may need frequent blood tests to check how quickly your blood clots.
- If you are using insulin, your doctor will tell you how to reduce the dose of insulin and will recommend you monitor your blood sugar more frequently, in order to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to breakdown glucose because there is not enough insulin).

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

This medicine should not be used during pregnancy, as it is not known if it affects your unborn baby.
Therefore, you have to use contraception while taking this medicine. If you wish to become pregnant, discuss how to change your treatment with your doctor as you should stop using this medicine at least 2 months in advance. If you become pregnant while using this medicine, talk to your doctor straight away, as your treatment will need to be changed.

Do not use this medicine if you are breast-feeding. The medicine passes into breast milk, and it is not known how it affects your baby.

Driving and using machines
Rybelsus is unlikely to affect your ability to drive and use machines.

Some patients may feel dizzy when taking Rybelsus. If you feel dizzy, be extra careful while driving or using machines. Talk to your doctor for the further information.

If you use this medicine in combination with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur which may reduce your ability to concentrate. Do not drive or use machines if you get any signs of low blood sugar. See section 2, ‘Warning and precautions’ for information on increased risk of low blood sugar and section 4 for the warning signs of low blood sugar. Talk to your doctor for further information.

Rybelsus contains sodium
Rybelsus 1.5 mg, 4 mg and 9 mg tablets: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Rybelsus 25 mg and 50 mg tablets: This medicine contains 23 mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to 1% of the recommended maximum daily dietary intake of sodium for an adult.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much to take

• The starting dose is one 1.5 mg tablet once a day for one month.
• After one month, your doctor will increase your dose to one 4 mg tablet once a day.
• Your doctor will instruct you to stay on a dose for minimum one month before increasing to a higher dose.
• Your doctor may step-wise increase your dose to one 9 mg, 25 mg or 50 mg tablet once a day if needed.
• Your doctor will prescribe the strength that is right for you. Do not change your dose unless your doctor has told you so.
• Rybelsus should always be taken as one tablet per day. You should not take two tablets to get the effect of a higher dose.

Taking this medicine
- Take your Rybelsus tablet on an empty stomach after a recommended fasting period of at least 8 hours.
- Swallow your Rybelsus tablet whole with a sip of water (up to 120 mL). Do not split, crush or chew the tablet, as it is not known if it affects absorption of semaglutide.
- After taking your Rybelsus tablet wait at least 30 minutes before eating, drinking or taking other oral medicines. Waiting less than 30 minutes lowers the absorption of semaglutide.

If you take more Rybelsus than you should
If you take more Rybelsus than you should, talk to your doctor straight away. You may get side effects such as feeling sick (nausea).

If you forget to take Rybelsus
If you forget to take a dose, skip the missed dose and just take your normal dose the next day.

If you stop taking Rybelsus
Do not stop using this medicine without talking to your doctor. If you stop using it, your blood sugar levels may increase.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Common (may affect up to 1 in 10 people)
- Complications of diabetic eye disease (retinopathy). You should tell your doctor if you get eye problems, such as changes in vision, during treatment with this medicine.

Rare (may affect up to 1 in 1 000 people)
- Serious allergic reactions (anaphylactic reactions). You must get immediate medical help and inform your doctor straight away if you get symptoms such as breathing problems, swelling of face and throat, wheezing, fast heartbeat, pale and cold skin, feeling dizzy or weak.
- Inflamed pancreas (acute pancreatitis) which could cause severe pain in the stomach and back which does not go away. You should see a doctor immediately if you experience such symptoms.

Very Rare (may affect up to 1 in 10 000 people)
- A medical condition of the eye called non-arteritic anterior ischaemic optic neuropathy (NAION), which may cause loss of vision to one of your eyes without any pain. You should immediately

contact your doctor if you notice sudden or gradually worsening eyesight (see section 2: “Sudden changes to your eyesight”)

Not known (frequency cannot be estimated from the available data)
- Bowel obstruction. A severe form of constipation with additional symptoms such as stomach ache, bloating, vomiting etc.

Other side effects

Very common (may affect more than 1 in 10 people)
- Low blood sugar (hypoglycaemia) when this medicine is used with medicines that contain a sulfonylurea or insulin. Your doctor may reduce your dose of these medicines before you start using this medicine.
- Feeling sick (nausea) - this usually goes away over time
- Diarrhoea - this usually goes away over time.

The warning signs of low blood sugar may come on suddenly. They can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking.
Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs.

Common (may affect up to 1 in 10 people)
- Low blood sugar (hypoglycaemia) when this medicine is used with oral diabetes medicine other than sulfonylurea or insulin
- Less appetite
- Feeling dizzy
- Being sick (vomiting) - this usually goes away over time and may happen more often when increasing your dose to 25 mg and 50 mg
- Stomach pain
- Bloating of the stomach
- Constipation
- Upset stomach or indigestion
- Inflamed stomach (‘gastritis’) - the signs include stomach ache, feeling sick (nausea) or being sick (vomiting)
- Reflux or heartburn - also called ‘gastro-esophageal reflux disease’
- Gas (flatulence)
- Tiredness
- Increase of pancreatic enzymes (such as lipase and amylase) shown in blood tests
- Changed skin sensation - this usually goes away over time and may happen more frequently with 25 mg and 50 mg than 1.5 mg, 4 mg and 9 mg
- Headache.

Uncommon (may affect up to 1 in 100 people)
- Allergic reactions like rash, itching or hives
- Change in the way food or drink tastes
- Fast pulse
- Burping
- A delay in the emptying of the stomach
- Gallstones
- Weight loss.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting

system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after ‘EXP’.
The expiry date refers to the last day of that month.

Store in the original package in order to protect from light and moisture.
This medicine does not require any special temperature storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Rybelsus contains
- The active substance is semaglutide. Each tablet contains 1.5, 4, 9, 25 or 50 mg semaglutide.
- The other ingredients are salcaprozate sodium, magnesium stearate. See also section 2, ‘Rybelsus contains sodium’.

What Rybelsus looks like and contents of the pack

Rybelsus 1.5 mg tablets are white to light yellow and round (6.5 mm in diameter). They have ‘1.5’ on one side and ‘novo’ on the other side.
Rybelsus 4 mg tablets are white to light yellow and round (6.5 mm in diameter). They have ‘4’ on one side and ‘novo’ on the other side.
Rybelsus 9 mg tablets are white to light yellow and round (6.5 mm in diameter). They have ‘9’ on one side and ‘novo’ on the other side.
Rybelsus 25 mg tablets are white to light yellow and oval shaped (6.8 mm × 12 mm). They have ‘25’ on one side and ‘novo’ on the other side.
Rybelsus 50 mg tablets are white to light yellow and oval shaped (6.8 mm × 12 mm). They have ‘50’ on one side and ‘novo’ on the other side.

The 1.5 mg, 4 mg, 9 mg, 25 mg and 50 mg tablets are available in alu/alu blister cards in pack sizes of 10, 30, 60, 90 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

This leaflet was last revised in

Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu/

Rybelsus contains the active substance semaglutide. It is a medicine that is used to lower blood sugar levels.

Rybelsus is used to treat adults (aged 18 years and older) with type 2 diabetes when diet and exercise is not enough:
- on its own - when you cannot use metformin (another diabetes medicine) or
- with other medicines for diabetes - when the other medicines are not enough to control your blood sugar levels. These may be medicines you take by mouth or inject such as insulin.

It is important that you continue with your diet and exercise plan as agreed with your doctor, pharmacist or nurse.

What is type 2 diabetes?
Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body makes does not lower your blood sugar the way it should. In some cases, your body can produce too much blood sugar. If your blood sugar increases and remains high over a long period of time, this can lead to harmful effects such as heart problems, kidney disease, eye disorders and poor circulation in your limbs. That is why it is important to keep your blood sugar levels within a normal range.

Do not take Rybelsus
- if you are allergic to semaglutide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Rybelsus.

Traceability
In order to improve the traceability of biological medicinal products, record the name and the lot number (included on the outer cartons and blister) of the medicine you are taking and provide this information when reporting any side effects.

General
This medicine is not the same as insulin and you should not use it if:
- you develop diabetic ketoacidosis. This is a complication of diabetes with high blood sugar, breathing difficulty, confusion, excessive thirst, a sweet smell to the breath or a sweet or metallic taste in the mouth.

If you know that you are due to have surgery where you will be under anaesthesia (sleeping), please tell your doctor that you are taking Rybelsus.

Stomach and gut problems and dehydration
During treatment with this medicine, you may feel sick (nausea) or be sick (vomiting), or have diarrhoea. These side effects can cause dehydration (loss of fluids). It is important that you drink enough fluids to prevent dehydration. This is especially important if you have kidney problems. Talk to your doctor if you have any questions or concerns.

Severe and on-going stomach pain which could be due to an inflamed pancreas
If you have severe and on-going pain in the stomach area - see a doctor straight away as this could be a sign of inflamed pancreas (acute pancreatitis).

Low blood sugar (hypoglycaemia)
Taking a sulfonylurea medicine or insulin with Rybelsus might increase the risk of getting low blood sugar (hypoglycaemia). See section 4 for the warning signs of low blood sugar levels.

Your doctor may ask you to test your blood sugar levels. This will help to decide if the dose of the sulfonylurea or insulin needs to be changed to reduce the risk of low blood sugar.

Diabetic eye disease (retinopathy)
Fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disease.
If you have diabetic eye disease and get eye problems while taking this medicine, talk to your doctor.

Treatment response
If the treatment response with semaglutide is lower than expected, this may be due to low absorption caused by variability in absorption and low absolute bioavailability. You should follow the instructions given in section 3 for optimal effect of semaglutide.

Sudden changes to your eyesight
If you notice a sudden loss of vision or rapidly worsening eyesight during treatment with this medicine, immediately contact your doctor for advice. This may be caused by a very rare side effect called non- arteritic anterior ischaemic optic neuropathy (NAION) (See section 4: Serious side effects). Your doctor may refer you for an eye examination and you may have to stop treatment with this medicine.

Patients with delayed stomach emptying (gastroparesis)
If you have slow (delayed) stomach emptying (called gastroparesis), use of Rybelsus may lead to serious or severe gastrointestinal adverse events. Talk to your doctor before using Rybelsus.

Children and adolescents
This medicine is not recommended in children and adolescents aged under 18 years as the safety and efficacy in this age group have not been established.

Other medicines and Rybelsus
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the following:
- Levothyroxine which is used for thyroid disease. This is because your doctor may need to check your thyroid levels if you are taking Rybelsus together with levothyroxine.
- Warfarin or similar medicines taken by mouth to reduce blood clotting (oral anti-coagulants).
You may need frequent blood tests to check how quickly your blood clots.
- If you are using insulin, your doctor will tell you how to reduce the dose of insulin and will recommend you monitor your blood sugar more frequently, in order to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to breakdown glucose because there is not enough insulin).

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

This medicine should not be used during pregnancy, as it is not known if it affects your unborn baby.
Therefore, you have to use contraception while taking this medicine. If you wish to become pregnant, discuss how to change your treatment with your doctor as you should stop using this medicine at least 2 months in advance. If you become pregnant while using this medicine, talk to your doctor straight away, as your treatment will need to be changed.

Do not use this medicine if you are breast-feeding. The medicine passes into breast milk, and it is not known how it affects your baby.

Driving and using machines
Rybelsus is unlikely to affect your ability to drive and use machines.

Some patients may feel dizzy when taking Rybelsus. If you feel dizzy, be extra careful while driving or using machines. Talk to your doctor for the further information.

If you use this medicine in combination with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur which may reduce your ability to concentrate. Do not drive or use machines if you get any signs of low blood sugar. See section 2, ‘Warning and precautions’ for information on increased risk of low blood sugar and section 4 for the warning signs of low blood sugar. Talk to your doctor for further information.

Rybelsus contains sodium
This medicine contains 23 mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to 1% of the recommended maximum daily dietary intake of sodium for an adult.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much to take
- The starting dose is one 3 mg tablet once a day for one month.
- After one month, your doctor will increase your dose to one 7 mg tablet once a day.
- Your doctor will instruct you to stay on a dose for minimum one month before increasing to a higher dose.

• Your doctor may step-wise increase your dose to one 14 mg, 25 mg or 50 mg tablet once a day if needed.
• Your doctor will prescribe the strength that is right for you. Do not change your dose unless your doctor has told you so.
• Rybelsus should always be taken as one tablet per day. You should not take two tablets to get the effect of a higher dose.

Taking this medicine
- Take your Rybelsus tablet on an empty stomach after a recommended fasting period of at least 8 hours.
- Swallow your Rybelsus tablet whole with a sip of water (up to 120 mL). Do not split, crush or chew the tablet, as it is not known if it affects absorption of semaglutide.
- After taking your Rybelsus tablet wait at least 30 minutes before eating, drinking or taking other oral medicines. Waiting less than 30 minutes lowers the absorption of semaglutide.

If you take more Rybelsus than you should
If you take more Rybelsus than you should, talk to your doctor straight away. You may get side effects such as feeling sick (nausea).

If you forget to take Rybelsus
If you forget to take a dose, skip the missed dose and just take your normal dose the next day.

If you stop taking Rybelsus
Do not stop using this medicine without talking to your doctor. If you stop using it, your blood sugar levels may increase.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Common (may affect up to 1 in 10 people)
- Complications of diabetic eye disease (retinopathy). You should tell your doctor if you get eye problems, such as changes in vision, during treatment with this medicine.

Rare (may affect up to 1 in 1 000 people)
- Serious allergic reactions (anaphylactic reactions). You must get immediate medical help and inform your doctor straight away if you get symptoms such as breathing problems, swelling of face and throat, wheezing, fast heartbeat, pale and cold skin, feeling dizzy or weak.
- Inflamed pancreas (acute pancreatitis) which could cause severe pain in the stomach and back which does not go away. You should see a doctor immediately if you experience such symptoms.

Very Rare (may affect up to 1 in 10 000 people)
- A medical condition of the eye called non-arteritic anterior ischaemic optic neuropathy (NAION), which may cause loss of vision to one of your eyes without any pain. You should immediately contact your doctor if you notice sudden or gradually worsening eyesight (see section 2: “Sudden changes to your eyesight”)

Not known (frequency cannot be estimated from the available data)
- Bowel obstruction. A severe form of constipation with additional symptoms such as stomach ache, bloating, vomiting etc.

Other side effects

Very common (may affect more than 1 in 10 people)
- Low blood sugar (hypoglycaemia) when this medicine is used with medicines that contain a sulfonylurea or insulin. Your doctor may reduce your dose of these medicines before you start using this medicine.
- Feeling sick (nausea) - this usually goes away over time
- Diarrhoea - this usually goes away over time.

The warning signs of low blood sugar may come on suddenly. They can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking.
Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs.

Common (may affect up to 1 in 10 people)
- Low blood sugar (hypoglycaemia) when this medicine is used with oral diabetes medicine other than sulfonylurea or insulin
- Less appetite
- Feeling dizzy
- Being sick (vomiting) - this usually goes away over time and may happen more often when increasing your dose to 25 mg and 50 mg
- Stomach pain
- Bloating of the stomach
- Constipation
- Upset stomach or indigestion
- Inflamed stomach (‘gastritis’) - the signs include stomach ache, feeling sick (nausea) or being sick (vomiting)
- Reflux or heartburn - also called ‘gastro-esophageal reflux disease’
- Gas (flatulence)
- Tiredness
- Increase of pancreatic enzymes (such as lipase and amylase) shown in blood tests
- Changed skin sensation - this usually goes away over time and may happen more frequently with 25 mg and 50 mg than 3 mg, 7 mg and 14 mg
- Headache.

Uncommon (may affect up to 1 in 100 people)
- Allergic reactions like rash, itching or hives
- Change in the way food or drink tastes
- Fast pulse
- Burping
- A delay in the emptying of the stomach
- Gallstones
- Weight loss.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after ‘EXP’.
The expiry date refers to the last day of that month.

Store in the original package in order to protect from light and moisture.
This medicine does not require any special temperature storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Rybelsus contains
- The active substance is semaglutide. Each tablet contains 3, 7, 14, 25 or 50 mg semaglutide.
- The other ingredients in the 3 mg, 7 mg and 14 mg tablets are salcaprozate sodium, povidone K90, cellulose microcrystalline, magnesium stearate. See also section 2, ‘Rybelsus contains sodium’.
- The other ingredients in the 25 mg and 50 mg tablets are salcaprozate sodium and magnesium stearate. See also section 2, ‘Rybelsus contains sodium’.

What Rybelsus looks like and contents of the pack
Rybelsus 3 mg tablets are white to light yellow and oval shaped (7.5 mm x 13.5 mm). They have ‘3’ on one side and ‘novo’ on the other side.
Rybelsus 7 mg tablets are white to light yellow and oval shaped (7.5 mm x 13.5 mm). They have ‘7’ on one side and ‘novo’ on the other side.
Rybelsus 14 mg tablets are white to light yellow and oval shaped (7.5 mm x 13.5 mm). They have ‘14’ on one side and ‘novo’ on the other side.
Rybelsus 25 mg tablets are white to light yellow and oval shaped (6.8 mm × 12 mm). They have ‘25’ on one side and ‘novo’ on the other side.
Rybelsus 50 mg tablets are white to light yellow and oval shaped (6.8 mm × 12 mm). They have ‘50’ on one side and ‘novo’ on the other side.

The 3 mg, 7 mg, 14 mg, 25 mg and 50 mg tablets are available in alu/alu blister cards in pack sizes of 10, 30, 60, 90 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

This leaflet was last revised in

Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu/

1.
What Wegovy is and what it is used for

What Wegovy is
Wegovy is a medicine for weight loss and weight maintenance that contains the active substance semaglutide. It is similar to a natural hormone called glucagon-like peptide-1 (GLP-1) that is released from the intestine after a meal. It works by acting on targets (receptors) in the brain that control your appetite, causing you to feel fuller and less hungry and experience less craving for food. This will help you eat less food and reduce your body weight. Wegovy can also help prevent heart disease. In the liver it reduces liver damage, likely due to improvements in metabolic factors, such as weight loss, improved blood sugar and lipid levels and lessening of inflammation.

What Wegovy is used for
Wegovy is used together with diet and physical activity for weight loss and to help keep the weight under control. It is used in adults, who have
- a BMI of 30 kg/m² or greater (obesity) or
- a BMI of at least 27 kg/m² but less than 30 kg/m² (overweight) who have weight-related health problems (such as diabetes, high blood pressure, abnormal levels of fats in the blood, breathing problems during sleep called ‘obstructive sleep apnoea’ or a history of heart attack, stroke or blood vessel problems).

BMI (Body Mass Index) is a measure of your weight in relation to your height.

Wegovy is used together with diet and physical activity for weight management in adolescents aged 12 years and above, who have
- obesity and
- body weight > 60 kg.

As an adolescent patient, you should only continue using Wegovy if you have lost at least 5% of your BMI after 12 weeks on the 2.4 mg dose or maximum tolerated dose (see section 3). Consult your doctor before you continue.

2.
What you need to know before you use Wegovy

Do not use Wegovy
- if you are allergic to semaglutide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Wegovy.

The use of Wegovy is not recommended if you:
- use other products for weight loss,
- have type 1 diabetes,
- have severely reduced kidney function,
- have moderately or severely reduced liver function and metabolic dysfunction-associated steatohepatitis (MASH),
- have severe heart failure,
- have uncontrolled or potentially unstable diabetic eye disease (retinopathy).

There is little experience with Wegovy in patients:
- of 85 years and older,
- with mild, moderately or severely reduced liver function,
- with inflammatory bowel disease.

Please consult your doctor if one of the above applies to you.

If you know that you are due to have surgery where you will be under anaesthesia (sleeping), please tell your doctor that you are taking Wegovy.

- Dehydration
During treatment with Wegovy, you may feel sick (nausea) or be sick (vomiting), or have diarrhoea. These side effects can cause dehydration (loss of fluids). It is important that you drink enough fluids to prevent dehydration. This is especially important if you have kidney problems. Talk to your doctor if you have any questions or concerns.

- Inflammation of the pancreas
If you have severe and on-going pain in the stomach area (see section 4) – see a doctor straight away as this could be a sign of inflamed pancreas (acute pancreatitis).

- People with type 2 diabetes
Wegovy cannot be used as a substitute for insulin. Do not use Wegovy in combination with other medicines that contain GLP-1 receptor agonists (such as liraglutide, dulaglutide, exenatide or lixisenatide).

- Low blood sugar (hypoglycaemia)
Taking a sulfonylurea or an insulin with Wegovy might increase the risk of getting low blood sugar levels (hypoglycaemia). Please see section 4 for the warning signs of low blood sugar levels. Your doctor may ask you to test your blood sugar levels. This will help your doctor decide if the dose of the sulfonylurea or insulin needs to be changed to reduce the risk of low blood sugar.

- Diabetic eye disease (retinopathy)
If you have diabetic eye disease and are using insulin, this medicine may lead to a worsening of your vision, and this may require treatment. Fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disease. If you have diabetic eye disease and experience eye problems while taking this medicine, talk to your doctor.

- Sudden changes to your eyesight
If you notice a sudden loss of vision or rapidly worsening eyesight during treatment with this medicine, immediately contact your doctor for advice. This may be caused by a very rare side effect called non-arteritic anterior ischaemic optic neuropathy (NAION) (See section 4: Serious side effects). Your doctor may refer you for an eye examination and you may have to stop treatment with this medicine.

- Patients with delayed stomach emptying (gastroparesis)
If you have slow (delayed) stomach emptying (called gastroparesis), use of Wegovy may lead to serious or severe gastrointestinal side effects. Talk to your doctor before using Wegovy.

Children and adolescents
Giving this medicine to children below 12 years of age is not recommended because the safety and efficacy have not been studied in this age group.

Other medicines and Wegovy
Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.

In particular, tell your doctor, pharmacist or nurse if you are using medicines containing the following:
- Warfarin or other similar medicines taken by mouth to reduce blood clotting (oral anti- coagulants). When you start treatment with e.g. warfarin or similar medicines, frequent blood testing to determine the ability of your blood to clot may be required.

Pregnancy and breast-feeding
This medicine should not be used during pregnancy, as it is not known if it may affect your unborn child. Therefore, it is recommended to use contraception while using this medicine. If you wish to become pregnant, you should stop using this medicine at least two months in advance. If you become or are pregnant, think you may be pregnant or are planning to have a baby when using this medicine, talk to your doctor straight away, as your treatment will need to be stopped.

Do not use this medicine if you are breast-feeding, as it is unknown if it passes into breast milk.

Driving and using machines
Wegovy is unlikely to affect your ability to drive and use machines. Some patients may feel dizzy when taking Wegovy mainly during the first 4 months of treatment (see section 4). If you feel dizzy be extra careful while driving or using machines. If you need any further information, talk to your doctor, pharmacist or nurse.

People with type 2 diabetes
If you use this medicine in combination with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur which may reduce your ability to concentrate. Avoid driving or using machines if you get any signs of low blood sugar. See section 2, ‘Warnings and precautions’ for information on increased risk of low blood sugar and section 4 for the warning signs of low blood sugar. Talk to your doctor for further information.

Wegovy contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.

3.
How to use Wegovy

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much to use
Adults

Your treatment will start at a low dose which will be gradually increased over 16 weeks of treatment.
- When you first start using Wegovy, the starting dose is 0.25 mg once weekly.
- Your doctor will instruct you to gradually increase your dose every 4 weeks until you reach the recommended dose of 2.4 mg once weekly.
- Your doctor may instruct you to increase your dose to 7.2 mg once weekly after a minimum of 4 weeks on the 2.4 mg.
- The maximum dose is 7.2 mg once weekly.
- In case you are feeling very bothered by sickness (nausea) or by being sick (vomiting) talk with your doctor about delaying dose escalation or lowering to the previous dose until symptoms have improved.

Usually, you will be told to follow the table below.

Dose escalation
Weekly dose
Week 1–4
0.25 mg
Week 5–8
0.5 mg
Week 9–12
1 mg
Week 13–16
1.7 mg
From week 17
2.4 mg
From week 21
2.4 mg or 7.2 mg

Your doctor will assess your treatment on a regular basis.

Adolescents (above 12 years of age)
For adolescents, the same dose escalation schedule as for adults should be applied (see above). The dose should be increased until 2.4 mg (maintenance dose) or maximum tolerated dose has been reached. Weekly doses higher than 2.4 mg are not recommended.

How Wegovy is given
Wegovy is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or muscle.
- The best places to give the injection are the front of your upper arm, upper legs or stomach.
- Before you use the pen for the first time, your doctor, pharmacist or nurse will show you how to use it.

Detailed instructions on how to use the pen are on the other side of this leaflet.

People with type 2 diabetes
Tell your doctor if you have type 2 diabetes. Your doctor may adjust the dose of your diabetes medicines to prevent you from getting low blood sugar.

When to use Wegovy
- You should use this medicine once a week and if possible, on the same day each week.
- You can give yourself the injection at any time of the day – regardless of meals.

If necessary, you can change the day of your weekly injection of this medicine as long as it has been at least 3 days since your last injection. After selecting a new dosing day, continue with once a week dosing.

If you use more Wegovy than you should
Talk to your doctor straight away. You may get side effects such as feeling sick (nausea), being sick (vomiting) or have diarrhoea, which may cause dehydration (loss of fluids).

If you forget to use Wegovy
If you forgot to inject a dose and:
- it is 5 days or less since you should have used Wegovy, use it as soon as you remember. Then inject your next dose as usual on your scheduled day.
- it is more than 5 days since you should have used Wegovy, skip the missed dose. Then inject your next dose as usual on your next scheduled day.
Do not use a double dose to make up for a forgotten dose.

If you stop using Wegovy
Do not stop using this medicine without talking to your doctor.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.
Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Common (may affect up to 1 in 10 people)
- Complications of diabetic eye disease (diabetic retinopathy). If you have diabetes you should inform your doctor if you experience eye problems, such as changes in vision, during treatment with this medicine.

Uncommon (may affect up to 1 in 100 people)
- Inflamed pancreas (acute pancreatitis). Signs of inflamed pancreas may include severe and long- lasting pain in your stomach, the pain may move to your back. You should see your doctor immediately if you experience such symptoms.

Rare (may affect up to 1 in 1 000 people)
- Severe allergic reactions (anaphylactic reactions, angioedema). You should seek immediate medical help and inform your doctor straight away if you get symptoms such as breathing difficulty, swelling, light-headedness, fast heartbeat, sweating and loss of consciousness or rapid swelling under the skin in areas such as the face, throat, arms and legs, which can be life threatening if throat swelling blocks the airway.

Very rare (may affect up to 1 in 10 000 people)
- A medical condition of the eye called non-arteritic anterior ischaemic optic neuropathy (NAION), which may cause loss of vision to one of your eyes without any pain. You should immediately contact your doctor if you notice sudden or gradually worsening eyesight (see section 2: “Sudden changes to your eyesight”).

Not known (frequency cannot be estimated from the available data)
- Bowel obstruction. A severe form of constipation with additional symptoms such as stomach ache, bloating, vomiting etc.

Other side effects

Very common (may affect more than 1 in 10 people)
- headache
- being sick (vomiting)
- diarrhoea

- constipation
- feeling sick (nausea)
- stomach pain
- feeling weak or tired (fatigue)
– these are mainly seen during dose escalation and usually go away over time.

Common (may affect up to 1 in 10 people)
- low blood sugar (hypoglycaemia) in patients with type 2 diabetes
- feeling dizzy
- change in the way food or drink tastes (dysgeusia)
- change in skin sensation (dysaesthesia)
- inflamed stomach (‘gastritis’) – the signs include stomach-ache, feeling sick (nausea) or being sick (vomiting)
- reflux or heartburn – also called ‘gastro-oesophageal reflux disease’
- upset stomach or indigestion (dyspepsia)
- burping (eructation)
- gas (flatulence)
- bloating of the stomach (abdominal distension)
- gallstones (cholelithiasis)
- hair loss – may occur more frequently with semaglutide 7.2 mg
- injection site reactions

The warning signs of low blood sugar (hypoglycaemia) may come on suddenly. They can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking.
Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs.
Low blood sugar is more likely to happen if you also take a sulfonylurea or insulin. Your doctor may reduce your dose of these medicines before you start using this medicine.

Uncommon (may affect up to 1 in 100 people)
- fast heartbeat
- low blood pressure (hypotension)
- feeling dizzy or lightheaded on standing or sitting up because of a drop in blood pressure (orthostatic hypotension)
- increase of pancreatic enzymes (such as lipase and amylase) shown in blood tests
- a delay in the emptying of the stomach.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.
How to store Wegovy

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pen label and carton after ‘EXP’.
The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C). Do not freeze. Keep away from the cooling element. Always store the pen in the original carton in order to protect from light.
Wegovy may be stored unrefrigerated for up to 28 days at a temperature not above 30°C.
Discard the pen if it has been exposed to light or temperatures above 30°C, has been out of the refrigerator for more than 28 days, or has been frozen.

Do not use this medicine if you notice that the solution is not clear and colourless or almost colourless.

After use: The pen is for single use and contains one dose only. Discard pen after use.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.
Contents of the pack and other information

What Wegovy contains
- The active substance is semaglutide.
Wegovy 0.25 mg solution for injection in pre-filled pen
Each pre-filled pen contains 0.25 mg semaglutide in 0.5 mL (0.5 mg/mL).

Wegovy 0.5 mg solution for injection in pre-filled pen
Each pre-filled pen contains 0.5 mg semaglutide in 0.5 mL (1 mg/mL).

Wegovy 1 mg solution for injection in pre-filled pen
Each pre-filled pen contains 1 mg semaglutide in 0.5 mL (2 mg/mL).

Wegovy 1.7 mg solution for injection in pre-filled pen
Each pre-filled pen contains 1.7 mg semaglutide in 0.75 mL (2.27 mg/mL).

Wegovy 2.4 mg solution for injection in pre-filled pen
Each pre-filled pen contains 2.4 mg semaglutide in 0.75 mL (3.2 mg/mL).

Wegovy 7.2 mg solution for injection in pre-filled pen
Each pre-filled pen contains 7.2 mg semaglutide in 0.75 mL (9.6 mg/mL).

• The other ingredients are disodium phosphate dihydrate, sodium chloride, hydrochloric acid/sodium hydroxide (for pH adjustment), water for injections. See also section 2 ‘Wegovy contains sodium’ for information on sodium.

What Wegovy looks like and contents of the pack
Wegovy is a clear and colourless or almost colourless solution for injection in a pre-filled disposable pen.

Each pen contains one dose only.

Pack size of 4 pre-filled pens.

Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

Pull out to get started
Wegovy 0.25 mg solution for injection in pre-filled pen
Wegovy 0.5 mg solution for injection in pre-filled pen
Wegovy 1 mg solution for injection in pre-filled pen
Wegovy 1.7 mg solution for injection in pre-filled pen
Wegovy 2.4 mg solution for injection in pre-filled pen
Wegovy 7.2 mg solution for injection in pre-filled pen semaglutide
Use Wegovy one time each week
0.25 mg
0.5 mg
1 mg
1.7 mg
2.4 mg

1.
What Wegovy is and what it is used for

What Wegovy is
Wegovy is a medicine for weight loss and weight maintenance that contains the active substance semaglutide. It is similar to a natural hormone called glucagon-like peptide-1 (GLP-1) that is released from the intestine after a meal. It works by acting on targets (receptors) in the brain that control your appetite, causing you to feel fuller and less hungry and experience less craving for food. This will help you eat less food and reduce your body weight. Wegovy can also help prevent heart disease. In the liver it reduces liver damage, likely due to improvements in metabolic factors, such as weight loss, improved blood sugar and lipid levels and lessening of inflammation.

What Wegovy is used for
Wegovy is used together with diet and physical activity for weight loss and to help keep the weight under control. It is used in adults, who have
- a BMI of 30 kg/m² or greater (obesity) or
- a BMI of at least 27 kg/m² but less than 30 kg/m² (overweight) who have weight-related health problems (such as diabetes, high blood pressure, abnormal levels of fats in the blood, breathing problems during sleep called ‘obstructive sleep apnoea’ or a history of heart attack, stroke or blood vessel problems).

BMI (Body Mass Index) is a measure of your weight in relation to your height.

Wegovy is used together with diet and physical activity for weight management in adolescents ages 12 years and above, who have
- obesity and
- body weight > 60 kg.

As an adolescent patient, you should only continue using Wegovy if you have lost at least 5% of your BMI after 12 weeks on the 2.4 mg dose or maximum tolerated dose (see section 3). Consult your doctor before you continue.

2.
What you need to know before you use Wegovy

Do not use Wegovy
- if you are allergic to semaglutide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Wegovy.

The use of Wegovy is not recommended if you:
- use other products for weight loss,
- have type 1 diabetes,
- have severely reduced kidney function,
- have moderately or severely reduced liver function and metabolic dysfunction-associated steatohepatitis (MASH),
- have severe heart failure,
- have uncontrolled or potentially unstable diabetic eye disease (retinopathy).

There is little experience with Wegovy in patients:
- of 85 years and older,
- with mild, moderately or severely reduced liver function,
- with inflammatory bowel disease.

Please consult your doctor if one of the above applies to you.

If you know that you are due to have surgery where you will be under anaesthesia (sleeping), please tell your doctor that you are taking Wegovy.

- Dehydration
During treatment with Wegovy, you may feel sick (nausea) or be sick (vomiting), or have diarrhoea. These side effects can cause dehydration (loss of fluids). It is important that you drink enough fluids to prevent dehydration. This is especially important if you have kidney problems. Talk to your doctor if you have any questions or concerns.

- Inflammation of the pancreas
If you have severe and on-going pain in the stomach area (see section 4) – see a doctor straight away as this could be a sign of inflamed pancreas (acute pancreatitis).

- People with type 2 diabetes
Wegovy cannot be used as a substitute for insulin. Do not use Wegovy in combination with other medicines that contain GLP-1 receptor agonists (such as liraglutide, dulaglutide, exenatide or lixisenatide).

- Low blood sugar (hypoglycaemia)
Taking a sulfonylurea or an insulin with Wegovy might increase the risk of getting low blood sugar levels (hypoglycaemia). Please see section 4 for the warning signs of low blood sugar levels. Your doctor may ask you to test your blood sugar levels. This will help your doctor decide if the dose of the sulfonylurea or insulin needs to be changed to reduce the risk of low blood sugar.

- Diabetic eye disease (retinopathy)
If you have diabetic eye disease and are using insulin, this medicine may lead to a worsening of your vision, and this may require treatment. Fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disease. If you have diabetic eye disease and experience eye problems while taking this medicine, talk to your doctor.

- Sudden changes to your eyesight.
If you notice a sudden loss of vision or rapidly worsening eyesight during treatment with this medicine, immediately contact your doctor for advice. This may be caused by a very rare side effect called non-arteritic anterior ischaemic optic neuropathy (NAION) (See section 4: Serious side effects). Your doctor may refer you for an eye examination and you may have to stop treatment with this medicine.

- Patients with delayed stomach emptying (gastroparesis)
If you have slow (delayed) stomach emptying (called gastroparesis), use of Wegovy may lead to serious or severe gastrointestinal side effects. Talk to your doctor before using Wegovy.

Children and adolescents
Do not give this medicine to children below 12 years of age because it has not been studied in this age group.

Other medicines and Wegovy
Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.

In particular, tell your doctor, pharmacist or nurse if you are using medicines containing the following:
- Warfarin or other similar medicines taken by mouth to reduce blood clotting (oral anti- coagulants). When you start treatment with e.g. warfarin or similar medicines, frequent blood testing to determine the ability of your blood to clot may be required.

Pregnancy and breast-feeding
This medicine should not be used during pregnancy, as it is not known if it may affect your unborn child. Therefore, it is recommended to use contraception while using this medicine. If you wish to become pregnant, you should stop using this medicine at least two months in advance. If you become or are pregnant, think you may be pregnant or are planning to have a baby when using this medicine, talk to your doctor straight away, as your treatment will need to be stopped.

Do not use this medicine if you are breast-feeding, as it is unknown if it passes into breast milk.

Driving and using machines
Wegovy is unlikely to affect your ability to drive and use machines. Some patients may feel dizzy when taking Wegovy mainly during the first 4 months of treatment (see section 4). If you feel dizzy be extra careful while driving or using machines. If you need any further information, talk to your doctor, pharmacist or nurse.

People with type 2 diabetes
If you use this medicine in combination with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur which may reduce your ability to concentrate. Avoid driving or using machines if you get any signs of low blood sugar. See section 2, ‘Warnings and precautions’ for information on increased risk of low blood sugar and section 4 for the warning signs of low blood sugar. Talk to your doctor for further information.
Wegovy contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.

3.
How to use Wegovy

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much to use
Adults
Your treatment will start at a low dose which will be gradually increased over 16 weeks of treatment.
- When you first start using Wegovy, the starting dose is 0.25 mg once weekly.
- Your doctor will instruct you to gradually increase your dose every 4 weeks until you reach the dose of 2.4 mg once weekly.
- Your doctor may instruct you to increase your dose to 7.2 mg once weekly (3 injections of 2.4 mg) after a minimum of 4 weeks on 2.4 mg.
- The maximum dose is 7.2 mg once weekly.
- In case you are feeling very bothered by sickness (nausea) or by being sick (vomiting) talk with your doctor about delaying dose escalation or lowering to the previous dose until symptoms have improved.

Usually, you will be told to follow the table below.

Dose escalation
Weekly dose
Week 1–4
0.25 mg
Week 5–8
0.5 mg
Week 9–12
1 mg
Week 13–16
1.7 mg
From week 17
2.4 mg
From week 21
2.4 mg or 7.2 mg

Your doctor will assess your treatment on a regular basis.

Adolescents (above 12 years of age)
For adolescents, the same dose escalation schedule as for adults should be applied (see above). The dose should be increased until 2.4 mg (maintenance dose) or maximum tolerated dose has been reached. Weekly doses higher than 2.4 mg are not recommended.

How Wegovy is given
Wegovy is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or muscle.
- The best places to give the injection are the front of your upper arm, upper legs or stomach.
- Before you use the pen for the first time, your doctor, pharmacist or nurse will show you how to use it.
For Wegovy 7.2 mg inject three doses of 2.4 mg one after each other. The injections can be given in the same body area but should be at least 5 cm apart.

Detailed instructions on how to use the pen are on the other side of this leaflet.

People with type 2 diabetes
Tell your doctor if you have type 2 diabetes. Your doctor may adjust the dose of your diabetes medicines to prevent you from getting low blood sugar.

When to use Wegovy
- You should use this medicine once a week and if possible, on the same day each week.
- You can give yourself the injection at any time of the day – regardless of meals.

If necessary, you can change the day of your weekly injection of this medicine as long as it has been at least 3 days since your last injection. After selecting a new dosing day, continue with once a week dosing.

If you use more Wegovy than you should
Talk to your doctor straight away. You may get side effects such as feeling sick (nausea), being sick (vomiting) or have diarrhoea, which may cause dehydration (loss of fluids).

If you forget to use Wegovy
If you forgot to inject a dose and:
- it is 5 days or less since you should have used Wegovy, use it as soon as you remember. Then inject your next dose as usual on your scheduled day.
- it is more than 5 days since you should have used Wegovy, skip the missed dose. Then inject your next dose as usual on your next scheduled day.
Do not use a double dose to make up for a forgotten dose.

If you stop using Wegovy
Do not stop using this medicine without talking to your doctor.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.
Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Common (may affect up to 1 in 10 people)
- Complications of diabetic eye disease (diabetic retinopathy). If you have diabetes you should inform your doctor if you experience eye problems, such as changes in vision, during treatment with this medicine.

Uncommon (may affect up to 1 in 100 people)
- Inflamed pancreas (acute pancreatitis). Signs of inflamed pancreas may include severe and long- lasting pain in your stomach, the pain may move to your back. You should see your doctor immediately if you experience such symptoms.

Rare (may affect up to 1 in 1 000 people)
- Severe allergic reactions (anaphylactic reactions, angioedema). You should seek immediate medical help and inform your doctor straight away if you get symptoms such as breathing difficulty, swelling, light-headedness, fast heartbeat, sweating and loss of consciousness or rapid swelling under the skin in areas such as the face, throat, arms and legs, which can be life threatening if throat swelling blocks the airway.

Very rare (may affect up to 1 in 10 000 people)
- A medical condition of the eye called non-arteritic anterior ischaemic optic neuropathy (NAION), which may cause loss of vision to one of your eyes without any pain. You should immediately contact your doctor if you notice sudden or gradually worsening eyesight (see section 2: “Sudden changes to your eyesight”)

Not known (frequency cannot be estimated from the available data)
- Bowel obstruction. A severe form of constipation with additional symptoms such as stomach ache, bloating, vomiting etc.

Other side effects

Very common (may affect more than 1 in 10 people)
- headache
- being sick (vomiting)

• diarrhoea
• constipation
• feeling sick (nausea)
• stomach pain
• feeling weak or tired (fatigue)
• these are mainly seen during dose escalation and usually go away over time.

Common (may affect up to 1 in 10 people)
- low blood sugar (hypoglycaemia) in patients with type 2 diabetes.• feeling dizzy
- change in the way food or drink tastes (dysgeusia)
- change in skin sensation (dysaesthesia)
- inflamed stomach (‘gastritis’) – the signs include stomach-ache, feeling sick (nausea) or being sick (vomiting)
- reflux or heartburn – also called ‘gastro-oesophageal reflux disease’
- upset stomach or indigestion (dyspepsia)
- burping (eructation)
- gas (flatulence)
- bloating of the stomach (abdominal distension)
- gallstones (cholelithiasis)
- hair loss – may occur more frequently with semaglutide 7.2 mg
- injection site reactions.

The warning signs of low blood sugar (hypoglycaemia) may come on suddenly. They can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking.
Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs.
Low blood sugar is more likely to happen if you also take a sulfonylurea or insulin. Your doctor may reduce your dose of these medicines before you start using this medicine.

Uncommon (may affect up to 1 in 100 people)
- fast heartbeat
- low blood pressure (hypotension)
- feeling dizzy or lightheaded on standing or sitting up because of a drop in blood pressure (orthostatic hypotension)
- increase of pancreatic enzymes (such as lipase and amylase) shown in blood tests
- a delay in the emptying of the stomach.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.
How to store Wegovy

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pen label and carton after ‘EXP’.
The expiry date refers to the last day of that month.

Before opening
Store in a refrigerator (2°C – 8°C). Do not freeze. Keep away from the cooling element.

During use
- You can keep the pen for 6 weeks when stored at a temperature below 30°C or in a refrigerator (2°C – 8°C) away from the cooling element. Do not freeze Wegovy and do not use it if it has been frozen.
- When you are not using the pen, keep the pen cap on in order to protect from light.

Do not use this medicine if you notice that the solution is not clear and colourless or almost colourless.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment

6.
Contents of the pack and other information

What Wegovy contains
- The active substance is semaglutide.
Wegovy 0.25 mg FlexTouch solution for injection in pre-filled pen
Each pre-filled pen contains 1 mg semaglutide in 1.5 mL (0.68 mg/mL).

Wegovy 0.5 mg FlexTouch solution for injection in pre-filled pen
1.5 mL: Each pre-filled pen contains 2 mg semaglutide in 1.5 mL (1.34 mg/mL).
3 mL: Each pre-filled pen contains 2 mg semaglutide in 3 mL (0.68 mg/mL).

Wegovy 1 mg FlexTouch solution for injection in pre-filled pen
Each pre-filled pen contains 4 mg semaglutide in 3 mL (1.34 mg/mL).

Wegovy 1.7 mg FlexTouch solution for injection in pre-filled pen
Each pre-filled pen contains 6.8 mg semaglutide in 3 mL (2.27 mg/mL).

Wegovy 2.4 mg FlexTouch solution for injection in pre-filled pen
Each pre-filled pen contains 9.6 mg semaglutide in 3 mL (3.2 mg/mL).

• The other ingredients are disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid/sodium hydroxide (for pH adjustment), water for injections. See also section 2 ‘Wegovy contains sodium’ for information on sodium.

What Wegovy looks like and contents of the pack
Wegovy is a clear and colourless or almost colourless solution for injection in a pre-filled pen.

Each pre-filled pen contains 4 doses. After having injected the 4 doses, there might still be solution left in the pen despite having administered correctly. Any solution left is insufficient for a dose and the pen should be disposed of.

Wegovy 0.25 mg, 0.5 mg, 1 mg and 1.7 mg FlexTouch solution for injection in pre-filled pen is available in the following pack size:
1 pre-filled pen and 4 disposable NovoFine Plus needles.

Wegovy 2.4 mg FlexTouch solution for injection in pre-filled pen is available in the following pack sizes:
1 pre-filled pen and 4 disposable NovoFine Plus needles.
3 pre-filled pens and 12 disposable NovoFine Plus needles

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

Novo Nordisk Production SAS
45, Avenue d’Orléans
28000 Chartres
France

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

Instructions on how to use Wegovy

Before you begin using your once-weekly Wegovy FlexTouch pen, always read these instructions carefully, and talk to your doctor, nurse or pharmacist about how to inject Wegovy correctly.

Wegovy pen is a dial-a-dose pen that contains four of your doses of Wegovy.

Please use the table inside the lid of the carton to keep track of how many injections you have used and how many doses remain in your pen.

Wegovy comes in five different pen variants, each containing one of the following prescribed doses of semaglutide:

0.25 mg
0.5 mg
1 mg
1.7 mg
2.4 mg

Always start by checking your pen label to make sure that it contains your prescribed dose of Wegovy.

Your pen is designed to be used with 30G, 31G, and 32G disposable needles up to a length of 8 mm.

The pack contains:
- Wegovy pen
- 4 NovoFine Plus needles
- Package leaflet

Wegovy FlexTouch pen (example)
Please note: Your pen may differ in size and your pen label may differ in colour from the example shown in the pictures.
These instructions apply to all Wegovy FlexTouch pens
Pen cap
Pen window
Dose counter
Dose pointer
Dose selector
Dose button
Expiry date
(EXP) on back of pen label
EXP:
Batch:

Outer needle cap
Inner needle cap
Needle
Paper tab
NovoFine Plus needle (example)
1 Prepare your pen with a new needle
Check the name and dose of your pen to make sure it contains your prescribed dose of Wegovy.

Pull off the pen cap.

(See figure A).
A
Check that the solution in your pen is clear and colourless or almost colourless.

Look through the pen window. If Wegovy looks cloudy or coloured, do not use the pen.

(See figure B).
B
Always use a new needle for each injection.

Take a needle when you are ready to take your injection. Check the paper tab and the outer needle cap for damages that could affect sterility. If any damage is seen, use a new needle.

Tear off the paper tab.

(See figure C).
C

Push the needle straight onto the pen. Turn until it is on tight.

(See figure D).
D

The needle is covered by two caps. You must remove both caps.
If you forget to remove both caps you will not inject any Wegovy.

Pull off the outer needle cap and keep it for later. You will need it to safely remove the needle from the pen after the injection.

Pull off the inner needle cap and dispose of it. A drop of Wegovy may appear at the needle tip. You must still check the Wegovy flow if you use a new pen for the first time. See ‘Check the flow with each new pen’.

Never use a bent or damaged needle. For more information about needle handling, see ‘About your needles’ below these instructions.

(See figure E).
E

Check the flow with each new pen
If your Wegovy pen is already in use, go to ‘2 Set your dose’.

Only check the Wegovy flow before your first injection with each new pen.

Turn the dose selector until you see the flow check symbol
(
).

(See figure F).
F

Make sure the flow check symbol lines up with the dose pointer.

(See figure G).

G

Check the flow
Hold the pen with the needle pointing up.

Press and hold in the dose button until the dose counter returns to
. The must line up with the dose pointer.

A drop of Wegovy should appear at the needle tip. This drop indicates that your pen is ready for use.

If a drop does not appear, check the flow again. This should only be done twice.

If there is still no drop, change the needle and check the flow once more.

Do not use the pen if a drop of Wegovy still does not appear.

(See figure H).
H
2 Set your dose
Turn the dose selector until the dose counter stops, and it shows your prescribed dose.

(See figure I).
I

The dashed line ( ) in the dose counter will guide you to your dose.

The dose selector clicks differently when turned forward, backwards or past your dose. You will hear a ‘click’ every time you turn the dose selector. Do not set the dose by counting the number of clicks you hear.

(See figure J).
J
Dashed line

When your prescribed dose lines up with the dose pointer, you have selected your dose. In this picture, the dose 0.25 mg is shown as an example.

If the dose counter stops before you reach your prescribed dose, see the section ‘Do you have enough Wegovy?’ below these instructions.

(See figure K).
K
Example:
0.25 mg selected

Choose your injection site

Choose your upper arms, upper legs or stomach (keep a 5 cm distance from your belly button).

You may inject in the same body area, but make sure it is not in the same spot as used the last time.

Upper arms
Stomach
Upper legs

3 Inject your dose
Insert the needle into your skin.

Make sure you can see the dose counter. Do not cover it with your fingers. This could interrupt the injection.

(See figure L).
L

Press and hold down the dose button until the dose counter shows
.

(See figure M).

Keep pressing the dose button with the needle in your skin and slowly count to 6. The must line up with the dose pointer. You may hear or feel a click when the dose counter returns to .

(See figure N).
M

N
Count slowly
1-2-3-4-5-6

Remove the needle from your skin. If the needle is removed earlier, a stream of Wegovy may come from the needle tip and the full dose will not be delivered.

If blood appears at the injection site, press lightly on the area to stop the bleeding.

You may see a drop of Wegovy at the needle tip after injecting. This is normal and does not affect your dose.

(See figure O).
O

4 After your injection
Lead the needle tip into the outer needle cap on a flat surface without touching the needle or the outer needle cap.

Once the needle is covered, carefully push the outer needle cap completely on.

(See figure P).
P

Unscrew the needle and dispose of it carefully as instructed by your doctor, nurse, pharmacist or local authorities.

Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.

Always dispose of the needle immediately after each injection to prevent blocked needles, contamination, infection, and inaccurate dosing. Never store your pen with the needle attached.

(See figure Q).
Q

Put the pen cap on your pen after each use to protect Wegovy from light.

(See figure R).

R

When the pen is empty, dispose of the pen without a needle on as instructed by your doctor, nurse, pharmacist, or local authorities.

The pen cap and the empty carton can be disposed of in your household waste.

About your needles

How to identify a blocked or damaged needle
- If does not appear in the dose counter after continuously pressing the dose button, you may have used a blocked or damaged needle.

• In this case, you have not received any Wegovy – even though the dose counter has moved from the original dose that you have set.

How to handle a blocked needle
- Change the needle as instructed in ‘1 Prepare your pen with a new needle’ and go to ‘2 Set your dose’.

Caring for your pen
Treat your pen with care. Rough handling or misuse may cause inaccurate dosing. If this happens, you might not get the intended effect of Wegovy.

• See the back of this leaflet to read the storage conditions for your pen.
• Do not inject Wegovy that has been exposed to direct sunlight.
• Do not subject Wegovy to frost and never inject Wegovy that has been frozen. Dispose of the pen.
• Do not drop your pen or knock it against hard surfaces.
• Do not try to refill your pen. Once empty, it must be disposed of.
• Do not try to repair your pen or pull it apart.
• Do not expose your pen to dust, dirt or liquid.
• Do not wash, soak or lubricate your pen. If necessary, clean it with a mild detergent on a moistened cloth.

Do you have enough Wegovy?
If the dose counter stops before you reach your prescribed dose, there is not enough Wegovy left for a full dose. Dispose of the pen and use a new Wegovy pen.

Important information
- Only use Wegovy once weekly as prescribed. If you do not use your Wegovy as prescribed, you may not get the intended effect of this medicine.
- If you use more than one type of injectable medicine, it is very important to check the name and dose of your pen label before use.
- Do not use this pen without help if you have poor eyesight and cannot follow these instructions. Get help from a person with good eyesight who is trained to use the Wegovy pen.
- Always keep pen and needles out of sight and reach of others, especially children.

• Never share your pen or your needles with other people.
• Needles are for single use only. Never reuse your needles as it may lead to blocked needles, contamination, infection and inaccurate dosing.
• Caregivers must be very careful when handling used needles to prevent accidental needle stick injuries and infection.

• Open the carton.
• Gently take out one syringe by holding the glass barrel.
• Check the syringe label. Confirm you have the dose prescribed by your doctor.

Do not hold or touch the syringe by the plunger rod or needle cap.

Keep the needle cap on, until you are ready to inject.

Medicine
EXP MM-YYYY

• Look through the glass barrel. Only use the syringe if the medicine appears as described in section 5 on the other side of this leaflet.

The expiry date can be found on the back side of the syringe label.

It is normal to see air bubbles. Do not try to remove bubbles.

Do not use the syringe if it appears to have been used, dropped, damaged or broken.

Stomach area or thighs
Back of upper arm
(only with help from someone else)

Inject under the skin of your:
• Stomach area (abdomen) at least 5 cm from the belly button.
• Thighs.
⸰ Back of upper arm (only with help from someone else).

Your doctor will help you choose the injection site that is best for you.

Avoid using the exact same spot as the last time you injected.

Inject your dose

• Pull the needle cap straight off and dispose of it.

You might see drops of medicine from the needle tip. This is normal and does not affect your dose.
Continue with your injection right away.
Do not put the needle cap back on the syringe, to avoid needle stick injuries.

• Gently make a skinfold and fully insert the syringe needle at a 45-degree angle.

You will reach under the skin and not the muscle.

• With a slow and constant pressure, push the plunger rod all the way in until the plunger stops.

When the plunger is at the bottom and the syringe is empty your dose is complete.

7. Remove your syringe

• Remove the needle at a 45-degree angle.

If blood appears at the injection site, press lightly on the area to stop the bleeding, without rubbing.

Dispose of your syringe
Be careful when handling used needles. Dispose of your syringe right away. Find disposal information in section 5 on the other side of this leaflet.

1.
What Wegovy is and what it is used for

What Wegovy is
Wegovy is a medicine for weight loss and weight maintenance that contains the active substance semaglutide. It is similar to a natural hormone called glucagon-like peptide-1 (GLP-1) that is released from the intestine after a meal. It works by acting on targets (receptors) in the brain that control your appetite, causing you to feel fuller and less hungry and experience less craving for food. This will help you eat less food and reduce your body weight. Wegovy can also help prevent heart disease.

What Wegovy is used for
Wegovy is used together with diet and physical activity for weight loss and to help keep the weight under control. It is used in adults, who have
- a BMI of 30 kg/m² or greater (obesity) or
- a BMI of at least 27 kg/m² but less than 30 kg/m² (overweight) who have weight-related health problems (such as diabetes, high blood pressure, abnormal levels of fats in the blood, breathing problems during sleep called ‘obstructive sleep apnoea’ or a history of heart attack, stroke or blood vessel problems).

BMI (Body Mass Index) is a measure of your weight in relation to your height.

2.
What you need to know before you take Wegovy

Do not take Wegovy
- if you are allergic to semaglutide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Wegovy.

The use of Wegovy is not recommended if you:
- use other products for weight loss,
- have type 1 diabetes,
- have severely reduced kidney function,
- have severely reduced liver function,
- have severe heart failure,
- have uncontrolled or potentially unstable diabetic eye disease (retinopathy).

There is little experience with Wegovy in patients:
- of 85 years and older,
- with liver problems,
- with inflammatory bowel disease,
- with type 2 diabetes having HbA1c below 8 for the 25 mg tablet,
- with type 2 diabetes using insulin for the 25 mg tablet.

Please consult your doctor if one of the above applies to you.

If you know that you are due to have surgery where you will be under anaesthesia (sleeping), please tell your doctor that you are taking Wegovy.

- Dehydration
During treatment with Wegovy, you may feel sick (nausea) or be sick (vomiting), or have diarrhoea.
These side effects can cause dehydration (loss of fluids). It is important that you drink enough fluids to prevent dehydration. This is especially important if you have kidney problems. Talk to your doctor if you have any questions or concerns.

- Inflammation of the pancreas
If you have severe and on-going pain in the stomach area (see section 4) – see a doctor straight away as this could be a sign of inflamed pancreas (acute pancreatitis).

- People with type 2 diabetes
Wegovy cannot be used as a substitute for insulin. Do not take Wegovy in combination with other medicines that contain GLP-1 receptor agonists (such as liraglutide, dulaglutide, exenatide or lixisenatide).

- Low blood sugar (hypoglycaemia)
Taking a sulfonylurea or an insulin with Wegovy might increase the risk of getting low blood sugar levels (hypoglycaemia). Please see section 4 for the warning signs of low blood sugar levels. Your doctor may ask you to test your blood sugar levels. This will help your doctor decide if the dose of the sulfonylurea or insulin needs to be changed to reduce the risk of low blood sugar.

- Diabetic eye disease (retinopathy)
If you have diabetic eye disease and are using insulin, this medicine may lead to a worsening of your vision, and this may require treatment. Fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disease. If you have diabetic eye disease and experience eye problems while taking this medicine, talk to your doctor.

- Sudden changes to your eyesight
If you notice a sudden loss of vision or rapidly worsening eyesight during treatment with this medicine, immediately contact your doctor for advice. This may be caused by a very rare side effect called non-arteritic anterior ischaemic optic neuropathy (NAION) (See section 4: Serious side effects). Your doctor may refer you for an eye examination and you may have to stop treatment with this medicine.

- Patients with delayed stomach emptying (gastroparesis)
If you have slow (delayed) stomach emptying (called gastroparesis), use of Wegovy may lead to serious or severe gastrointestinal side effects. Talk to your doctor before using Wegovy.

- Treatment response
If the treatment response with semaglutide is lower than expected, this may be due to low absorption caused by variability in absorption and low absolute bioavailability. You should follow the instructions given in section 3 for optimal effect of semaglutide.

Children and adolescents
Do not give this medicine to children or adolescents below 18 years of age as it has not been studied in this age group.

Other medicines and Wegovy
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor, pharmacist or nurse if you are using medicines containing the following:
- levothyroxine which is used for thyroid disease. This is because your doctor may need to check your thyroid levels if you are taking Wegovy together with levothyroxine.
- warfarin or similar medicines taken by mouth to reduce blood clotting (oral anti-coagulants).
You may need frequent blood tests to check how quickly your blood clots.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

This medicine should not be used during pregnancy, as it is not known if it affects your unborn baby.
Therefore, it is recommended to use contraception while taking this medicine. If you wish to become pregnant, discuss how to change your treatment with your doctor as you should stop using this medicine at least 2 months in advance. If you become pregnant while using this medicine, talk to your doctor straight away, as your treatment will need to be changed.

Do not use this medicine if you are breast-feeding. The medicine passes into breast milk, and it is not known how it affects your baby.

Driving and using machines
Wegovy is unlikely to affect your ability to drive and use machines. Some patients may feel dizzy when taking Wegovy mainly during the first 4 months of treatment (see section 4). If you feel dizzy be extra careful while driving or using machines. If you need any further information, talk to your doctor, pharmacist or nurse.

People with type 2 diabetes
If you use this medicine in combination with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur which may reduce your ability to concentrate. Avoid driving or using machines if you get any signs of low blood sugar. See section 2, ‘Warnings and precautions’ for information on increased risk of low blood sugar and section 4 for the warning signs of low blood sugar. Talk to your doctor for further information.

Wegovy contains sodium
Wegovy 1.5 mg, 4 mg and 9 mg tablets contain less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Wegovy 25 mg tablets contain 23 mg sodium (main component of cooking/table salt) in each tablet.
This is equivalent to 1% of the recommended maximum daily dietary intake of sodium for an adult.

3.
How to take Wegovy

Always take this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much to take
Your treatment will start at a low dose which will be gradually increased over 12 weeks of treatment.
- The starting dose is one 1.5 mg tablet once a day for four weeks.
- Your doctor will instruct you to gradually increase your dose every four weeks until you reach the recommended dose of 25 mg once daily. If needed, the dose can be maintained at the previous dose level.
- Once you reach the recommended dose of 25 mg, do not increase this dose further.

Usually, you will be told to follow as below:

Dose escalation
Daily dose
Week 1–4
1.5 mg
Week 5–8
4 mg
Week 9–12
9 mg
From week 13
25 mg

Your doctor will assess your treatment on a regular basis. You should not take two tablets to get the effect of a higher dose.

Taking this medicine
- Take your Wegovy tablet on an empty stomach after a recommended fasting period of at least 8 hours.
- Swallow your Wegovy tablet whole with a sip of water (up to 120 mL). Do not split, crush or chew the tablet, as it is not known if it affects absorption of semaglutide.
- After taking your Wegovy tablet wait at least 30 minutes before eating or drinking or taking other oral medicines. Waiting less than 30 minutes lowers the absorption of semaglutide.

People with type 2 diabetes
Tell your doctor if you have type 2 diabetes. Your doctor may adjust the dose of your diabetes medicines to prevent you from getting low blood sugar.

If you take more Wegovy than you should
Talk to your doctor straight away. You may get side effects such as feeling sick (nausea).

If you forget to take Wegovy
If you forget to take a dose, skip the missed dose and just take your normal dose the next day.

If you stop taking Wegovy
Do not stop using this medicine without talking to your doctor. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.
Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Common (may affect up to 1 in 10 people)
- Complications of diabetic eye disease (diabetic retinopathy). If you have diabetes you should inform your doctor if you experience eye problems, such as changes in vision, during treatment with this medicine.
Uncommon (may affect up to 1 in 1 00 people)
- Inflamed pancreas (acute pancreatitis). Signs of inflamed pancreas may include severe and long- lasting pain in your stomach, the pain may move to your back. You should see your doctor immediately if you experience such symptoms.

Rare (may affect up to 1 in 1 000 people)
- Severe allergic reactions (anaphylactic reactions, angioedema). You should seek immediate medical help and inform your doctor straight away if you get symptoms such as breathing difficulty, swelling, light-headedness, fast heartbeat, sweating and loss of consciousness or rapid swelling under the skin in areas such as the face, throat, arms and legs, which can be life threatening if throat swelling blocks the airway.

Very rare (may affect up to 1 in 10 000 people)
- A medical condition of the eye called non-arteritic anterior ischaemic optic neuropathy (NAION), which may cause loss of vision to one of your eyes without any pain. You should immediately contact your doctor if you notice sudden or gradually worsening eyesight (see section 2: “Sudden changes to your eyesight”).

Not known (frequency cannot be estimated from the available data)
- Bowel obstruction. A severe form of constipation with additional symptoms such as stomachache, bloating, vomiting etc.

Other side effects

Very common (may affect more than 1 in 10 people)
- headache
- being sick (vomiting)
- diarrhoea
- constipation
- upset stomach or indigestion (dyspepsia)
- feeling sick (nausea)
- stomach pain
- feeling weak or tired (fatigue)
– these are mainly seen during dose escalation and usually go away over time.

Common (may affect up to 1 in 10 people)
- low blood sugar (hypoglycaemia) in patients with type 2 diabetes
- feeling dizzy
- change in the way food or drink tastes (dysgeusia)
- change in skin sensation (dysaesthesia)
- inflamed stomach (‘gastritis’) – the signs include stomach-ache, feeling sick (nausea) or being sick (vomiting)
- reflux or heartburn – also called ‘gastro-oesophageal reflux disease’
- burping (eructation)
- gas (flatulence)
- bloating of the stomach (abdominal distension)
- gallstones (cholelithiasis)
- hair loss

The warning signs of low blood sugar (hypoglycaemia) may come on suddenly. They can include cold sweat, cool pale skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking.
Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs.
Low blood sugar is more likely to happen if you also take a sulfonylurea or insulin. Your doctor may reduce your dose of these medicines before you start using this medicine.

Uncommon (may affect up to 1 in 100 people)
- fast heartbeat
- low blood pressure (hypotension)
- feeling dizzy or lightheaded on standing or sitting up because of a drop in blood pressure (orthostatic hypotension)
- increase of pancreatic enzymes (such as lipase and amylase) shown in blood tests
- a delay in the emptying of the stomach.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.
How to store Wegovy

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after ‘EXP’.
The expiry date refers to the last day of that month.

Store in the original package in order to protect from light and moisture. This medicine does not require any special temperature storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.
Contents of the pack and other information

What Wegovy contains

The active substance is semaglutide.
Wegovy 1.5 mg tablets
Each tablet contains 1.5 mg semaglutide.

Wegovy 4 mg tablets
Each tablet contains 4 mg semaglutide.

Wegovy 9 mg tablets
Each tablet contains 9 mg semaglutide.

Wegovy 25 mg tablets
Each tablet contains 25 mg semaglutide.

The other ingredients are salcaprozate sodium and magnesium stearate. See also section 2 ‘Wegovy contains sodium’ for information on sodium.

What Wegovy looks like and contents of the pack
Wegovy 1.5 mg tablets are white to light yellow and round (6.5 mm in diameter). They have ‘1.5’ on one side and ‘novo’ on the other side.
Wegovy 4 mg tablets are white to light yellow and round (6.5 mm in diameter). They have ‘4’ on one side and ‘novo’ on the other side.
Wegovy 9 mg tablets are white to light yellow and round (6.5 mm in diameter). They have ‘9’ on one side and ‘novo’ on the other side.
Wegovy 25 mg tablets are white to light yellow and oval shaped (6.8 mm x 12 mm). They have ‘25’ on one side and ‘novo’ on the other side.

Wegovy 1.5 mg, 4 mg, 9 mg and 25 mg tablets are available in alu/alu blisters in pack sizes of 10, 30 and 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

This leaflet was last revised in

Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.