liraglutide: package leaflet

Week 4

Week 5 onwards

Once you reach the recommended dose of 3.0 mg in week 5 of treatment, keep using this dose until your treatment period ends. Do not increase your dose further.

Your doctor will assess your treatment on a regular basis.

Children and adolescents (6 to 18 years)
For children and adolescents from the age of 6 to below 18 years old a similar dose escalation schedule as for adults should be applied (see above table for adults). The dose should be increased until 3.0 mg (maintenance dose) or maximum tolerated dose has been reached. Daily doses higher than 3.0 mg are not recommended.

How and when to use Ablymico
- Before you use the pen for the first time, your doctor or nurse will show you how to use the pen.
- You can use Ablymico at any time of the day, with or without food and drink.
- Use Ablymico at about the same time each day – choose a time of the day that works best for you.

Where to inject
Ablymico is given as an injection under the skin (subcutaneous injection).
- The best places to inject are the front of your waist (abdomen), the front of your thighs or your upper arm.
- Change the place where you inject each day to reduce the risk of developing lumps.
- Do not inject into a vein or muscle.

Detailed instructions for use are provided on the other side of this leaflet.

People with diabetes
Tell your doctor if you have diabetes. Your doctor may adjust the dose of your diabetes medicines to prevent you from getting low blood sugar.
- Do not mix Ablymico up with other medicines that you inject (e.g. insulins).
- Do not use Ablymico in combination with other medicines that contain GLP-1 receptor agonists (such as exenatide or lixisenatide).

If you use more Ablymico than you should
If you use more Ablymico than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. You may need medical treatment. The following effects may happen:
- feeling sick (nausea)

• being sick (vomiting)
• low blood sugar (hypoglycaemia). Please refer to ‘Common side effects’ for warning signs of low blood sugar.

If you forget to use Ablymico
- If you forget a dose and remember it within 12 hours from when you usually use the dose, inject it as soon as you remember.
- However, if more than 12 hours have passed since you should have used Ablymico, skip the missed dose and inject your next dose the following day at the usual time.
- Do not use a double dose or increase the dose on the following day to make up for the missed dose.

If you stop using Ablymico
Do not stop using Ablymico without talking to your doctor.

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

Some severe allergic reactions (anaphylaxis) have been reported rarely in patients using liraglutide.
You should see your doctor straight away if you get symptoms such as breathing problems, swelling of face and throat and a fast heartbeat.

Cases of inflammation of the pancreas (pancreatitis) have been reported uncommonly in patients using liraglutide. Pancreatitis is a serious, potentially life-threatening medical condition.
Stop taking Ablymico and contact a doctor immediately if you notice any of the following serious side effects:
- Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis)

Other side effects

Very common: may affect more than 1 in 10 people
- Feeling sick (nausea), being sick (vomiting), diarrhoea, constipation, headache – these usually go away after a few days or weeks

Common: may affect up to 1 in 10 people
- Problems affecting the stomach and intestines, such as indigestion (dyspepsia), inflammation in the lining of the stomach (gastritis), stomach discomfort, upper stomach pain, heartburn, feeling bloated, wind (flatulence), belching and dry mouth
- Feeling weak or tired
- Changed sense of taste
- Dizziness
- Difficulty sleeping (insomnia). This usually occurs during the first 3 months of treatment
- Gallstones
- Rash
- Injection site reactions (such as bruising, pain, irritation, itching and rash)
- Low blood sugar (hypoglycaemia). The warning signs of low blood sugar may come on suddenly and can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick, feeling very hungry, changes in vision, feeling sleepy, feeling weak, being nervous, being

anxious, confusion, difficulty concentrating and shaking (tremor). Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs.
- increase of pancreatic enzymes, such as lipase and amylase

Uncommon: may affect up to 1 in 100 people
- Loss of fluids (dehydration). This is more likely to occur at the start of treatment and may be due to being sick (vomiting), feeling sick (nausea) and diarrhoea
- Delay in the emptying of the stomach
- Inflamed gall bladder
- Allergic reactions including skin rash
- Feeling generally unwell
- Faster pulse

Rare: may affect up to 1 in 1 000 people
- Reduced kidney function
- Acute kidney failure. Signs may include reduction in urine volume, metallic taste in mouth and easily bruising

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
- Lumps under the skin may be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known)

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 Ablymico 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 first use:

Store in a refrigerator (2 °C-8 °C). Do not freeze. Keep away from the freezer compartment.

Once you start using the pen:

You can keep the pen for 1 month when stored at a temperature below 30 °C or in a refrigerator (2 °C-8 °C). Do not freeze. Keep away from the freezer compartment.

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

Do not use this medicine if 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 Ablymico contains
- The active substance is liraglutide. 1 mL solution for injection contains 6 mg liraglutide. One pre-filled pen contains 18 mg liraglutide.
- The other ingredients are propylene glycol, disodium hydrogen phosphate dihydrate, phenol, sodium hydroxide and hydrochloric acid (for pH adjustment) and water for injections.

What Ablymico looks like and contents of the pack
Ablymico is supplied as a clear and colourless or almost colourless solution for injection in a pre-filled pen. Each pen contains 3 mL solution and is able to deliver doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg.

Ablymico is available in pack sizes containing 1, 3 or 5 pens.

Not all pack sizes may be marketed. Needles are not included.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Universal Farma, S.L
C. El Tejido, 2
19200 Azuqueca de Henares, Guadalajara
Spain

STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
EG (Eurogenerics) NV
Tél/Tel: +32 24797878
Lietuva
UAB „STADA Baltics“
Tel: +370 52603926

България
STADA Bulgaria EOOD
Teл.: +359 29624626
Luxembourg/Luxemburg
EG (Eurogenerics) NV
Tél/Tel: +32 24797878

Česká republika
STADA PHARMA CZ s.r.o.
Tel: +420 257888111
Magyarország
STADA Hungary Kft
Tel.: +36 18009747

Danmark
STADA Nordic ApS
Tlf: +45 44859999
Malta
Pharma.MT Ltd.
Tel: + 356 21337008

Deutschland
STADAPHARM GmbH
Tel: +49 61016030
Nederland
Centrafarm B.V.
Tel.: +31 765081000

Eesti
UAB „STADA Baltics“
Tel: +372 53072153
Norge
STADA Nordic ApS
Tlf: +45 44859999

Ελλάδα
FΑRAN S.A.
Τηλ: +30 2106254175

Österreich
STADA Arzneimittel GmbH
Tel: +43 136785850
España
Laboratorio STADA, S.L.
Tel: +34 934738889
Polska
STADA Pharm Sp. z o.o.
Tel: +48 227377920

France
EG Labo - Laboratoires EuroGenerics
Tél: +33 146948686
Portugal
Stada, Lda.
Tel: +351 211209870

Hrvatska
STADA d.o.o.
Tel: +385 13764111
România
STADA M&D SRL
Tel: +40 213160640

Ireland
Clonmel Healthcare Ltd.
Tel: +353 526177777
Slovenija
Stada d.o.o.
Tel: +386 15896710

Ísland
STADA Nordic ApS
Tlf: +45 44859999
Slovenská republika
STADA PHARMA Slovakia, s.r.o.
Tel: +421 252621933

Italia
EG SpA
Tel: +39 028310371
Suomi/Finland
STADA Nordic ApS, Suomen sivuliike
Puh/Tel: +358 207416888

Κύπρος
STADA Arzneimittel AG
Τηλ: +30 2106664667
Sverige
STADA Nordic ApS
Tel: +45 44859999

Latvija
UAB „STADA Baltics“
Tel: : +371 28016404

This leaflet was last revised in {month YYYY}.

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

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

Instructions on how to use Ablymico 6 mg/mL solution for injection in pre-filled pen

Please read these instructions carefully before using your Ablymico pre-filled pen.
Do not use the pen without proper training from your doctor or nurse.
Start by checking your pen to make sure that it contains Ablymico 6 mg/mL, 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 is trained to use the Ablymico pre-filled pen.
Your pen is a pre-filled dial-a-dose pen. It contains 18 mg of liraglutide and delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg. Your pen is designed to be used with disposable needles up to a length of 8 mm and as thin as 32 G.
Needles are not included in the pack.

Important information
Pay special attention to these notes as they are important for safe use of the pen.

Prepare your pen with a new needle

• Check the name and coloured label of your pen, to make sure that it contains Ablymico. 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.

• Check that the solution in your pen is clear and colourless. If the solution looks cloudy, do not use the pen.

• Take a new needle and tear off the paper tab.

Make sure to attach the needle correctly.

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

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.

• 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.
Do not attach a new needle to your pen until you are ready to take your injection.

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.

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 is positioned exactly in the centre of the display bulge.

• 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 be positioned exactly in the centre of the display bulge.
A drop of solution should appear at the needle tip.

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.
If a drop still does not appear, dispose of the pen and use a new one.

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 Ablymico.

Select your dose

- Turn the dose selector until the dose counter shows your dose (0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3.0 mg).
If you select the wrong dose, you can turn the dose selector forward or backwards to the correct dose.
The pen can dial up to a maximum of 3.0 mg.

The dose selector changes the dose. Only the dose counter will show how many mg you select per dose.
You can select up to 3.0 mg per dose. When your pen contains less than 3.0 mg the dose counter stops before 3.0 is shown.
The dose selector clicks differently when turned forward, backwards or past the number of mg left. Do not count the pen clicks.

Always use the dose counter to see how many mg you have selected before injecting this medicine.
Do not count the pen clicks.
Do not use the pen scale. It only shows approximately how much solution is left in your pen.
Only doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3.0 mg must be selected with the dose selector.
The selected dose must be positioned exactly in the centre of the display bulge to ensure that you get a correct dose.

How much solution is left?

• The pen scale shows you approximately how much solution is left in your pen.

- To see precisely how much solution is left, use the dose counter: Turn the dose selector until the dose counter stops.
If it shows 3.0, at least 3.0 mg are left in your pen. If the dose counter stops before 3.0 mg, there is not enough solution left for a full dose of 3.0 mg.

If you need more medicine than what is left in your pen
A

Only if trained or advised by your doctor or nurse, you may split your dose between your current pen and a new pen. Use a calculator to plan the doses as instructed by your doctor or nurse.

Be very careful to calculate correctly.
If you are not sure how to split your dose using two pens, then select and inject the dose you need with a new pen.

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.

• Press and hold down the dose button. Watch as the dose counter returns to 0. The 0 must be positioned exactly in the centre of the display bulge. You may then hear or feel a click.
• Continue pressing the dose button while keeping the needle in your skin.

• 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.

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

If blood appears at the injection site, press lightly.

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 shows 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.

After your injection

• Always dispose of the needle after each injection to ensure convenient injection 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.

• 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.

• Put the pen cap on your pen after each use to protect the solution from light.

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 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 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.
• Change the place where you inject each day to reduce the risk of developing lumps.

Caring for your pen

• Do not leave the pen in a car or other place where it can get too hot or too cold.
• Do not inject Ablymico which has been frozen. If you do that, you may 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.

Liraglutide STADA contains the active substance liraglutide. It helps your body reduce your blood sugar level only when blood sugar is too high. It also slows food passage through your stomach and can help prevent heart disease.

Liraglutide STADA is used on its own if your blood sugar is not properly controlled by diet and exercise alone, and you cannot use metformin (another diabetes medicine).

Liraglutide STADA is used with other medicines for diabetes when they are not enough to control your blood sugar levels. These may include:
- oral antidiabetics (such as metformin, pioglitazone, sulfonylurea, sodium-glucose cotransporter 2 inhibitor (SGLT2i)) and/or insulin.

Do not use Liraglutide STADA
- if you are allergic to liraglutide 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 Liraglutide STADA.
- if you have or have had a disease of the pancreas.

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 Liraglutide STADA.

This medicine should not be used if you have type 1 diabetes (your body does not produce any insulin) or diabetic ketoacidosis (a complication of diabetes with high blood sugar and increase in effort to breathe). It is not an insulin and should therefore not be used as a substitute for insulin.

The use of Liraglutide STADA is not recommended if you are on dialysis.
The use of Liraglutide STADA is not recommended if you have severe liver disease.
The use of Liraglutide STADA is not recommended if you have severe heart failure.

This medicine is not recommended if you have a severe stomach or gut problem which results in delayed stomach emptying (called gastroparesis), or inflammatory bowel disease.

If you have symptoms of acute pancreatitis, such as persistent, severe stomach ache, you should consult your doctor immediately (see section 4).

If you have thyroid disease including thyroid nodules and enlargement of the thyroid gland, consult your doctor.

When initiating treatment with Liraglutide STADA, you may in some cases experience loss of fluids/dehydration, e.g. in case of vomiting, nausea and diarrhoea. It is important to avoid dehydration by drinking plenty of fluids. Contact your doctor if you have any questions or concerns.

Children and adolescents
Liraglutide STADA can be used in adolescents and children aged 10 years and above. No data are available in children below 10 years of age.

Other medicines and Liraglutide STADA
Please 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 any of the following active substances:
- Sulfonylurea (such as glimepiride or glibenclamide) or insulin. You may get hypoglycaemia (low blood sugar) when using Liraglutide STADA together with a sulfonylurea or insulin, as sulfonylureas and insulin increase the risk of hypoglycaemia. When you first start using these medicines together, your doctor may tell you to lower the dose of the sulfonylurea or insulin.
Please see section 4 for the warning signs of low blood sugar. If you are also taking a sulfonylurea (such as glimepiride or glibenclamide) or insulin, your doctor may tell you to test your blood sugar levels. This will help your doctor to decide if the dose of the sulfonylurea or insulin needs to be changed.
- 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).
- Warfarin or other oral anti-coagulation medicines. More frequent blood testing to determine the ability of your blood to clot may be required.

Pregnancy and breast-feeding
Tell your doctor if you are, you think you might be, or are planning to become pregnant. Liraglutide STADA should not be used during pregnancy because it is not known if it may harm your unborn child.

It is not known if liraglutide passes into breast milk, therefore do not use this medicine if you are breast- feeding.

Driving and using machines
Low blood sugar (hypoglycaemia) may reduce your ability to concentrate. Avoid driving or using machines if you experience signs of hypoglycaemia. Please see section 4 for the warning signs of low blood sugar. Please consult your doctor for further information on this topic.

Liraglutide STADA contains sodium
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.

- The starting dose is 0.6 mg once a day, for at least one week.
- Your doctor will tell you when to increase it to 1.2 mg once a day.
- Your doctor may tell you to further increase the dose to 1.8 mg once a day, if your blood glucose is not adequately controlled with a dose of 1.2 mg.
Do not change your dose unless your doctor has told you to.

Liraglutide STADA is given as an injection under the skin (subcutaneous). Do not inject it into a vein or muscle. The best places to give yourself the injection are the front of your thighs, the front of your waist (abdomen), or your upper arm. Change the place where you inject each day to reduce the risk of developing lumps.

You can give yourself the injection at any time of the day, regardless of meals. When you have found the most convenient time of the day it is preferred that you inject Liraglutide STADA around the same time of the day.

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 provided on the other side of this leaflet.

If you use more Liraglutide STADA than you should
If you use more Liraglutide STADA than you should, talk to your doctor straight away. You may need medical treatment. You may experience nausea, vomiting, diarrhoea or low blood sugar (hypoglycaemia). Please refer to section 4 for warning signs of low blood sugar.

If you forget to use Liraglutide STADA
If you forget a dose, use Liraglutide STADA as soon as you remember.
However, if it is more than 12 hours since you should have used Liraglutide STADA, skip the missed dose. Then take your next dose as usual the following day.
Do not take an extra dose or increase the dose on the following day to make up for the missed dose.

If you stop using Liraglutide STADA
Do not stop using Liraglutide STADA 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
- Hypoglycaemia (low blood sugar). The warning signs of low blood sugar may come on suddenly and can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick, feeling very hungry, changes in vision, feeling sleepy, feeling weak, nervous, anxious, confused, difficulty concentrating, shaking (tremor). Your doctor will tell you how to treat low

blood sugar and what to do if you notice these warning signs. This 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 Liraglutide STADA.

Rare: may affect up to 1 in 1 000 people
- A severe form of allergic reaction (anaphylactic reaction) with additional symptoms such as breathing problems, swelling of throat and face, fast heartbeat, etc. If you experience these symptoms you should seek immediate medical help and inform your doctor as soon as possible.
- Bowel obstruction. A severe form of constipation with additional symptoms such as stomach ache, bloating, vomiting etc.

Very rare: may affect up to 1 in 10 000 people
- Cases of inflammation of the pancreas (pancreatitis). Pancreatitis can be a serious, potentially life-threatening medical condition. Stop taking Liraglutide STADA and contact a doctor immediately if you notice any of the following serious side effects:

Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis).

Other side effects

Very common: may affect more than 1 in 10 people
- Nausea (feeling sick). This usually goes away over time.
- Diarrhoea. This usually goes away over time.

Common: may affect up to 1 in 10 people
- Vomiting

When initiating treatment with Liraglutide STADA, you may in some cases experience loss of fluids/dehydration, e.g. in case of vomiting, nausea and diarrhoea. It is important to avoid dehydration by drinking plenty of fluids.

• Headache
• Indigestion
• Inflamed stomach (gastritis). The signs include stomach ache, nausea and vomiting.
• Gastro-oesophageal reflux disease (GORD). The signs include heartburn.
• Painful or swollen tummy (abdomen)
• Abdominal discomfort
• Constipation
• Wind (flatulence)
• Decreased appetite
• Bronchitis
• Common cold
• Dizziness
• Increased pulse
• Tiredness
• Toothache
• Injection site reactions (such as bruising, pain, irritation, itching and rash)
• Increase of pancreatic enzymes (such as lipase and amylase)

Uncommon: may affect up to 1 in 100 people
- Allergic reactions like pruritus (itching) and urticaria (a type of skin rash)
- Dehydration, sometimes with a decrease in kidney function
- Malaise (feeling unwell)
- Gallstones

• Inflamed gallbladder
• Change in how things taste
• A delay in the emptying of the stomach

Not known: frequency cannot be estimated from the available data
- Lumps under the skin may be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known).

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 freezer compartment.

During use:
You can keep the pen for 1 month when stored at a temperature below 30 °C or in a refrigerator (2 °C-8 °C), away from the freezer compartment. Do not freeze.
When you are not using the pen, keep the pen cap on in order to protect from light.

Do not use this medicine if 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 Liraglutide STADA contains
- The active substance is liraglutide. 1 ml solution for injection contains 6 mg liraglutide. One pre- filled pen contains 18 mg liraglutide.
- The other ingredients are propylene glycol, disodium hydrogen phosphate dihydrate, phenol, sodium hydroxide and hydrochloric acid (for pH adjustment) and water for injections.

What Liraglutide STADA looks like and contents of the pack
Liraglutide STADA is supplied as a clear, and colourless or almost colourless, solution for injection in a pre-filled pen. Each pen contains 3 ml of solution, delivering 30 doses of 0.6 mg, 15 doses of 1.2 mg or 10 doses of 1.8 mg.

Liraglutide STADA is available in packs containing 1, 2, 3, 5 or 10 pens.

Not all pack sizes may be marketed. Needles are not included.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18

61118 Bad Vilbel
Germany
Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Universal Farma, S.L
C. El Tejido, 2
19200 Azuqueca de Henares, Guadalajara
Spain

STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
EG (Eurogenerics) NV
Tél/Tel: +32 24797878
Lietuva
UAB „STADA Baltics“
Tel: +370 52603926

България
STADA Bulgaria EOOD
Teл.: +359 29624626
Luxembourg/Luxemburg
EG (Eurogenerics) NV
Tél/Tel: +32 24797878

Česká republika
STADA PHARMA CZ s.r.o.
Tel: +420 257888111
Magyarország
STADA Hungary Kft
Tel.: +36 18009747

Danmark
STADA Nordic ApS
Tlf: +45 44859999
Malta
Pharma.MT Ltd.
Tel: + 356 21337008

Deutschland
STADAPHARM GmbH
Tel: +49 61016030
Nederland
Centrafarm B.V.
Tel.: +31 765081000

Eesti
UAB „STADA Baltics“
Tel: +372 53072153
Norge
STADA Nordic ApS
Tlf: +45 44859999

Ελλάδα
FΑRAN S.A.
Τηλ: +30 2106254175

Österreich
STADA Arzneimittel GmbH
Tel: +43 136785850

España
Laboratorio STADA, S.L.
Tel: +34 934738889
Polska
STADA Pharm Sp. z o.o.
Tel: +48 227377920

France
Portugal

EG Labo - Laboratoires EuroGenerics
Tél: +33 146948686
Stada, Lda.
Tel: +351 211209870

Hrvatska
STADA d.o.o.
Tel: +385 13764111
România
STADA M&D SRL
Tel: +40 213160640

Ireland
Clonmel Healthcare Ltd.
Tel: +353 526177777
Slovenija
Stada d.o.o.
Tel: +386 15896710

Ísland
STADA Nordic ApS
Tlf: +45 44859999
Slovenská republika
STADA PHARMA Slovakia, s.r.o.
Tel: +421 252621933

Italia
EG SpA
Tel: +39 028310371
Suomi/Finland
STADA Nordic ApS, Suomen sivuliike
Puh/Tel: +358 207416888

Κύπρος
STADA Arzneimittel AG
Τηλ: +30 2106664667
Sverige
STADA Nordic ApS
Tel: +45 44859999

Latvija
UAB „STADA Baltics“
Tel: +371 28016404

This leaflet was last revised in {month YYYY}.

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

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

INSTRUCTIONS FOR
USING THE
LIRAGLUTIDE STADA PEN

Please read these instructions carefully before using your pen.

Your pen comes with 18 mg of liraglutide. You can select doses of 0.6 mg, 1.2 mg and 1.8 mg.
The pen is designed to be used with disposable injection needles up to a length of 8 mm and as thin as 32 G (0.25/0.23 mm).

Needle (example)

Liraglutide STADA pen
Prepare your pen

Check the name and coloured label of your pen to make sure that it contains liraglutide.
Using the wrong medicine could cause severe harm.

Pull off the pen cap.

Pull off the paper tab from a new disposable needle. Screw the needle straight and tightly onto your pen.

Pull off the outer needle cap and keep it for later.

Pull off the inner needle cap and dispose of it.

Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage of liraglutide, blocked needles and inaccurate dosing.
Be careful not to bend or damage the needle.
Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.
Caring for your pen
- Do not try to repair your pen or pull it apart.
- Keep your pen away from dust, dirt and all kinds of liquids.
- Clean the pen with a cloth moistened with a mild detergent.
- Do not try to wash, soak or lubricate it – this can harm the pen.
Important information
- Do not share your pen or needles with anyone else.
- Keep your pen out of the reach of others, especially children.
- Change the place where you inject each day to reduce the risk of developing lumps.

With each new pen, check the flow

Check the flow before your first injection with each new pen. If your pen is already in use, go to ‘Select your dose’, step I.

Turn the dose selector until the flow check symbol lines up with the pointer.

Hold the pen with the needle pointing up. Tap the cartridge gently with your finger a few times. This will make any air bubbles collect at the top of the cartridge.

Keep the needle pointing up and press the dose button until 0 mg lines up with the pointer.

A drop of liraglutide should appear at the needle tip.
If no drop appears, repeat steps F to H up to four times.

If there is still no drop of liraglutide, change the needle and repeat steps F to H once more.

Do not use the pen if a drop of liraglutide still does not appear. This indicates the pen is defective and you must use a new one.

If you have dropped your pen against a hard surface or suspect that something is wrong with it, always put on a new disposable needle and check the flow before you inject.

Select your dose

Always check that the pointer lines up with 0 mg.

Turn the dose selector until your needed dose lines up with the pointer (0.6 mg, 1.2 mg or 1.8 mg).

If you selected a wrong dose by mistake, simply change it by turning the dose selector backwards or forwards until the right dose lines up with the pointer.

Be careful not to press the dose button when turning the dose selector backwards, as liraglutide may come out.

If the dose selector stops before your needed dose lines up with the pointer, there is not enough liraglutide left for a full dose. Then you can either:

Split your dose into two injections:
Turn the dose selector in either direction until 0.6 mg or 1.2 mg lines up with the pointer. Inject the dose.
Then prepare a new pen for injection and inject the remaining number of mg to complete your dose.

You may only split your dose between your current pen and a new pen if trained or advised by your healthcare professional. Use a calculator to plan the doses. If you split the dose wrong, you may inject too much or too little liraglutide.

Inject the full dose with a new pen:
If the dose selector stops before 0.6 mg lines up with the pointer, prepare a new pen and inject the full dose with the new pen.

Do not try to select other doses than 0.6 mg, 1.2 mg or 1.8 mg. The numbers in the display must line up precisely with the pointer to ensure that you get the correct dose.
The dose selector clicks when you turn it. Do not use these clicks to select your dose.
Do not use the cartridge scale to measure how much liraglutide to inject – it is not accurate enough.
Inject your dose

Insert the needle into your skin using the injection technique shown by your doctor or nurse. Then follow the instructions below:

Press the dose button to inject until 0 mg lines up with the pointer. Be careful not to touch the display with your other fingers or press the dose selector sideways when you inject. This is because it may block the injection.
Keep the dose button pressed down and leave the needle under the skin for at least 6 seconds. This is to make sure that you get your full dose.

I

Pull out the needle.
After that, you may see a drop liraglutide at the needle tip.
This is normal and does not affect your dose.

Guide the needle tip into the outer needle cap without touching the needle or the outer needle cap.

When the needle is covered, carefully push the outer needle cap completely on. Then unscrew the needle.
Dispose of it carefully and put the pen cap back on.

When the pen is empty, carefully dispose of it without a needle attached. Please dispose of the pen and needle in accordance with local requirements.

Always remove the needle after each injection and store your pen without a needle attached.
This reduces the risk of contamination, infection, leakage of liraglutide, blocked needles and inaccurate dosing.
Caregivers must be very careful when handling used needles – to prevent needle injury and cross-infection.

Week 4

Week 5 onwards

Once you reach the recommended dose of 3.0 mg in week 5 of treatment, keep using this dose until your treatment period ends. Do not increase your dose further.

Your doctor will assess your treatment on a regular basis.

Children and adolescents (6 to 18 years)
For children and adolescents from the age of 6 to below 18 years old a similar dose escalation schedule as for adults should be applied (see above table for adults). The dose should be increased until 3.0 mg (maintenance dose) or maximum tolerated dose has been reached. Daily doses higher than 3.0 mg are not recommended.

How and when to use Saxenda
- Before you use the pen for the first time, your doctor or nurse will show you how to use the pen.
- You can use Saxenda at any time of the day, with or without food and drink.
- Use Saxenda at about the same time each day – choose a time of the day that works best for you.

Where to inject
Saxenda is given as an injection under the skin (subcutaneous injection).
- The best places to inject are the front of your waist (abdomen), the front of your thighs or your upper arm.
- Change the place where you inject each day to reduce the risk of developing lumps.
- Do not inject into a vein or muscle.

Detailed instructions for use are provided on the other side of this leaflet.

People with diabetes
Tell your doctor if you have diabetes. Your doctor may adjust the dose of your diabetes medicines to prevent you from getting low blood sugar.
- Do not mix Saxenda up with other medicines that you inject (e.g. insulins).
- Do not use Saxenda in combination with other medicines that contain GLP-1 receptor agonists (such as exenatide or lixisenatide).

If you use more Saxenda than you should
If you use more Saxenda than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. You may need medical treatment. The following effects may happen:
- feeling sick (nausea)
- being sick (vomiting)
- low blood sugar (hypoglycaemia). Please refer to ‘Common side effects’ for warning signs of low blood sugar.

If you forget to use Saxenda
- If you forget a dose and remember it within 12 hours from when you usually use the dose, inject it as soon as you remember.
- However, if more than 12 hours have passed since you should have used Saxenda, skip the missed dose and inject your next dose the following day at the usual time.
- Do not use a double dose or increase the dose on the following day to make up for the missed dose.

If you stop using Saxenda
Do not stop using Saxenda without talking to your doctor.

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

Some severe allergic reactions (anaphylaxis) have been reported rarely in patients using Saxenda. You should see your doctor straight away if you get symptoms such as breathing problems, swelling of face and throat and a fast heartbeat.

Cases of inflammation of the pancreas (pancreatitis) have been reported uncommonly in patients using Saxenda. Pancreatitis is a serious, potentially life-threatening medical condition.
Stop taking Saxenda and contact a doctor immediately if you notice any of the following serious side effects:
- Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis).

Other side effects

Very common: may affect more than 1 in 10 people
- Feeling sick (nausea), being sick (vomiting), diarrhoea, constipation, headache – these usually go away after a few days or weeks.

Common: may affect up to 1 in 10 people
- Problems affecting the stomach and intestines, such as indigestion (dyspepsia), inflammation in the lining of the stomach (gastritis), stomach discomfort, upper stomach pain, heartburn, feeling bloated, wind (flatulence), belching and dry mouth
- Feeling weak or tired
- Changed sense of taste
- Dizziness
- Difficulty sleeping (insomnia). This usually occurs during the first 3 months of treatment
- Gallstones

• Rash
• Injection site reactions (such as bruising, pain, irritation, itching and rash)
• Low blood sugar (hypoglycaemia). The warning signs of low blood sugar may come on suddenly and can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick, feeling very hungry, changes in vision, feeling sleepy, feeling weak, being nervous, being anxious, confusion, difficulty concentrating and shaking (tremor). Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs
• increase of pancreatic enzymes, such as lipase and amylase.

Uncommon: may affect up to 1 in 100 people
- Loss of fluids (dehydration). This is more likely to occur at the start of treatment and may be due to being sick (vomiting), feeling sick (nausea) and diarrhoea
- Delay in the emptying of the stomach
- Inflamed gall bladder
- Allergic reactions including skin rash
- Feeling generally unwell
- Faster pulse.

Rare: may affect up to 1 in 1 000 people
- Reduced kidney function
- Acute kidney failure. Signs may include reduction in urine volume, metallic taste in mouth and easily bruising.

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.
- Lumps under the skin may be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known).

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 Saxenda 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 first use:

Store in a refrigerator (2 °C - 8 °C). Do not freeze. Keep away from the freezer compartment.

Once you start using the pen:

You can keep the pen for 1 month when stored at a temperature below 30 °C or in a refrigerator (2 °C - 8 °C). Do not freeze. Keep away from the freezer compartment.

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

Do not use this medicine if 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 Saxenda contains
- The active substance is liraglutide. 1 ml solution for injection contains 6 mg liraglutide. One pre-filled pen contains 18 mg liraglutide.
- The other ingredients are disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections.

What Saxenda looks like and contents of the pack
Saxenda is supplied as a clear and colourless or almost colourless solution for injection in a pre-filled pen. Each pen contains 3 ml solution and is able to deliver doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg.

Saxenda is available in pack sizes containing 1, 3 or 5 pens. Not all pack sizes may be marketed.

Needles are not included.

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

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

Novo Nordisk Production SAS
45 Avenue D Orleans
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 website:
http://www.ema.europa.eu.

Instructions on how to use Saxenda 6 mg/ml solution for injection in pre-filled pen

Please read these instructions carefully before using your Saxenda pre-filled pen.
Do not use the pen without proper training from your doctor or nurse.
Start by checking your pen to make sure that it contains Saxenda 6 mg/ml, 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 is trained to use the Saxenda pre-filled pen.
Your pen is a pre-filled dial-a-dose pen. It contains 18 mg of liraglutide and delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg. Your pen is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm and as thin as 32 G.
Needles are not included in the pack.

Important information
Pay special attention to these notes as they are important for safe use of the pen.

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

1 Prepare your pen with a new needle

• Check the name and coloured label of your pen, to make sure that it contains Saxenda. 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, do not use the pen.

B

• Take a new needle and 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.
Do not attach a new needle to your pen until you are ready to take your injection.

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.

F

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.

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.
If a drop still does not appear, dispose of the pen and use a new one.

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 Saxenda.

B

3 Select your dose

- Turn the dose selector until the dose counter shows your dose (0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3.0 mg).
If you select the wrong dose, you can turn the dose selector forward or backwards to the correct dose.
The pen can dial up to a maximum of 3.0 mg.

The dose selector changes the dose. Only the dose counter and dose pointer will show how many mg you select per dose.
You can select up to 3.0 mg per dose. When your pen contains less than 3.0 mg the dose counter stops before 3.0 is shown.
The dose selector clicks differently when turned forward, backwards or past the number of mg left. Do not count the pen clicks.

Always use the dose counter and the dose pointer to see how many mg you have selected before injecting this medicine.
Do not count the pen clicks.
Do not use the pen scale. It only shows approximately how much solution is left in your pen.
Only doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3.0 mg must be selected with the dose selector. The selected dose must line up precisely with the dose pointer to ensure that you get a correct dose.

A
Example
0.6 mg selected

How much solution is left?

• The pen scale shows you approximately how much solution is left in your pen.

A
Approx.
how much solution is left

- To see precisely how much solution is left, use the dose counter:
Turn the dose selector until the dose counter stops.
If it shows 3.0, at least 3.0 mg are left in your pen. If the dose counter stops before 3.0 mg, there is not enough solution left for a full dose of 3.0 mg.

If you need more medicine than what is left in your pen
Only if trained or advised by your doctor or nurse, you may split your dose between your current pen and a new pen. Use a calculator to plan the doses as instructed by your doctor or nurse.

Be very careful to calculate correctly.
If you are not sure how to split your dose using two pens, then select and inject the dose you need with a new pen.

B
Example
Dose counter stopped:
2.4 mg left

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
Count slowly:
1-2-3-4-5-6

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

If blood appears at the injection site, press lightly.

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 shows 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.

D

5 After your injection

• Always dispose of the needle after each injection to ensure convenient injection 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.

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

C

Further important information

• Always keep your pen and needles out of 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.
• Change the place where you inject each day to reduce the risk of developing lumps.

Caring for your pen

• Do not leave the pen in a car or other place where it can get too hot or too cold.
• Do not inject Saxenda which has been frozen. If you do that, you may 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.

Victoza contains the active substance liraglutide. It helps your body reduce your blood sugar level only when blood sugar is too high. It also slows food passage through your stomach and can help prevent heart disease.

Victoza is used on its own if your blood sugar is not properly controlled by diet and exercise alone, and you cannot use metformin (another diabetes medicine).

Victoza is used with other medicines for diabetes when they are not enough to control your blood sugar levels. These may include:
- oral antidiabetics (such as metformin, pioglitazone, sulfonylurea, sodium-glucose cotransporter 2 inhibitor (SGLT2i)) and/or insulin.

Do not use Victoza
- if you are allergic to liraglutide 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 Victoza.
- if you have or have had a disease of the pancreas.

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 victoza.

This medicine should not be used if you have type 1 diabetes (your body does not produce any insulin) or diabetic ketoacidosis (a complication of diabetes with high blood sugar and increase in effort to breathe). It is not an insulin and should therefore not be used as a substitute for insulin.

The use of Victoza is not recommended if you are on dialysis.
The use of Victoza is not recommended if you have severe liver disease.
The use of Victoza is not recommended if you have severe heart failure.

This medicine is not recommended if you have a severe stomach or gut problem which results in delayed stomach emptying (called gastroparesis), or inflammatory bowel disease.

If you have symptoms of acute pancreatitis, such as persistent, severe stomach ache, you should consult your doctor immediately (see section 4).

If you have thyroid disease including thyroid nodules and enlargement of the thyroid gland, consult your doctor.

When initiating treatment with Victoza, you may in some cases experience loss of fluids/dehydration, e.g. in case of vomiting, nausea and diarrhoea. It is important to avoid dehydration by drinking plenty of fluids. Contact your doctor if you have any questions or concerns.

Children and adolescents
Victoza can be used in adolescents and children aged 10 years and above. No data are available in children below 10 years of age.

Other medicines and Victoza
Please 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 any of the following active substances:
- Sulfonylurea (such as glimepiride or glibenclamide) or insulin. You may get hypoglycaemia (low blood sugar) when using Victoza together with a sulfonylurea or insulin, as sulfonylureas and insulin increase the risk of hypoglycaemia. When you first start using these medicines together, your doctor may tell you to lower the dose of the sulfonylurea or insulin. Please see section 4 for the warning signs of low blood sugar. If you are also taking a sulfonylurea (such as glimepiride or glibenclamide) or insulin, your doctor may tell you to test your blood sugar levels. This will help your doctor to decide if the dose of the sulfonylurea or insulin needs to be changed.
- 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).
- Warfarin or other oral anti-coagulation medicines. More frequent blood testing to determine the ability of your blood to clot may be required.

Pregnancy and breast-feeding
Tell your doctor if you are, you think you might be, or are planning to become pregnant. Victoza should not be used during pregnancy because it is not known if it may harm your unborn child.

It is not known if Victoza passes into breast milk, therefore do not use this medicine if you are breast- feeding.

Driving and using machines
Low blood sugar (hypoglycaemia) may reduce your ability to concentrate. Avoid driving or using machines if you experience signs of hypoglycaemia. Please see section 4 for the warning signs of low blood sugar. Please consult your doctor for further information on this topic.

Important information about some of the ingredients of Victoza
This medicine contains less than 1 mmol sodium (23 mg) per dose. This means that it is 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.

- The starting dose is 0.6 mg once a day, for at least one week.
- Your doctor will tell you when to increase it to 1.2 mg once a day.
- Your doctor may tell you to further increase the dose to 1.8 mg once a day, if your blood glucose is not adequately controlled with a dose of 1.2 mg.
Do not change your dose unless your doctor has told you to.

Victoza is given as an injection under the skin (subcutaneous). Do not inject it into a vein or muscle.
The best places to give yourself the injection are the front of your thighs, the front of your waist (abdomen), or your upper arm. Change the place where you inject each day to reduce the risk of developing lumps.

You can give yourself the injection at any time of the day, regardless of meals. When you have found the most convenient time of the day it is preferred that you inject Victoza around the same time of the day.

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 provided on the other side of this leaflet.

If you use more Victoza than you should
If you use more Victoza than you should, talk to your doctor straight away. You may need medical treatment. You may experience nausea, vomiting, diarrhoea or low blood sugar (hypoglycaemia).
Please refer to section 4 for warning signs of low blood sugar.

If you forget to use Victoza
If you forget a dose, use Victoza as soon as you remember.
However, if it is more than 12 hours since you should have used Victoza, skip the missed dose. Then take your next dose as usual the following day.
Do not take an extra dose or increase the dose on the following day to make up for the missed dose.

If you stop using Victoza
Do not stop using Victoza 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
- Hypoglycaemia (low blood sugar). The warning signs of low blood sugar may come on suddenly and can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick, feeling very hungry, changes in vision, feeling sleepy, feeling weak, nervous, anxious, confused, difficulty concentrating, shaking (tremor). Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs. This 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 Victoza.

Rare: may affect up to 1 in 1,000 people
- A severe form of allergic reaction (anaphylactic reaction) with additional symptoms such as breathing problems, swelling of throat and face, fast heartbeat, etc. If you experience these symptoms you should seek immediate medical help and inform your doctor as soon as possible.
- Bowel obstruction. A severe form of constipation with additional symptoms such as stomach ache, bloating, vomiting etc.

Very rare: may affect up to 1 in 10,000 people
- Cases of inflammation of the pancreas (pancreatitis). Pancreatitis can be a serious, potentially life-threatening medical condition. Stop taking Victoza and contact a doctor immediately if you notice any of the following serious side effects:

Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis).

Other side effects
Very common: may affect more than 1 in 10 people
- Nausea (feeling sick). This usually goes away over time.
- Diarrhoea. This usually goes away over time.

Common
- Vomiting.

When initiating treatment with Victoza, you may in some cases experience loss of fluids/dehydration, e.g. in case of vomiting, nausea and diarrhoea. It is important to avoid dehydration by drinking plenty of fluids.

• Headache
• Indigestion
• Inflamed stomach (gastritis). The signs include stomach ache, nausea and vomiting.
• Gastro-oesophageal reflux disease (GORD). The signs include heartburn.
• Painful or swollen tummy (abdomen)
• Abdominal discomfort
• Constipation
• Wind (flatulence)
• Decreased appetite
• Bronchitis
• Common cold
• Dizziness
• Increased pulse
• Tiredness
• Toothache
• Injection site reactions (such as bruising, pain, irritation, itching and rash)
• Increase of pancreatic enzymes (such as lipase and amylase).

Uncommon: may affect up to 1 in 100 people
- Allergic reactions like pruritus (itching) and urticaria (a type of skin rash)
- Dehydration, sometimes with a decrease in kidney function
- Malaise (feeling unwell)
- Gallstones
- Inflamed gallbladder
- Change in how things taste
- A delay in the emptying of the stomach.

Not known: frequency cannot be estimated from the available data
• Lumps under the skin may be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known).

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 freezer compartment.

During use:
You can keep the pen for 1 month when stored at a temperature below 30˚C or in a refrigerator (2˚C– 8˚C), away from the freezer compartment. Do not freeze.
When you are not using the pen, keep the pen cap on in order to protect from light.

Do not use this medicine if 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 Victoza contains
- The active substance is liraglutide. 1 ml solution for injection contains 6 mg liraglutide. One pre-filled pen contains 18 mg liraglutide.
- The other ingredients are disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.

What Victoza looks like and contents of the pack
Victoza is supplied as a clear, and colourless or almost colourless, solution for injection in a pre-filled pen. Each pen contains 3 ml of solution, delivering 30 doses of 0.6 mg, 15 doses of 1.2 mg or 10 doses of 1.8 mg.

Victoza is available in packs containing 1, 2, 3, 5 or 10 pens. Not all pack sizes may be marketed.
Needles are not included.

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 website:
http://www.ema.europa.eu

INSTRUCTIONS FOR USING THE VICTOZA PEN
Please read these instructions carefully before using your pen.
Your pen comes with 18 mg of liraglutide. You can select doses of 0.6 mg, 1.2 mg and 1.8 mg.
The pen is designed to be used with NovoFine or
NovoTwist disposable injection needles up to a length of
8 mm and as thin as 32G (0.25/0.23 mm).
Prepare your pen

Check the name and coloured label of your pen to make sure that it contains liraglutide. Using the wrong medicine could cause severe harm.

Pull off the pen cap.

Pull off the paper tab from a new disposable needle.
Screw the needle straight and tightly onto your pen.
Pull off the outer needle cap and keep it for later.
Pull off the inner needle cap and dispose of it.

Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage of liraglutide, blocked needles and inaccurate dosing.

Be careful not to bend or damage the needle.

Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.
Caring for your pen
- Do not try to repair your pen or pull it apart.
- Keep your pen away from dust, dirt and all kinds of liquids.
- Clean the pen with a cloth moistened with a mild detergent.

• Do not try to wash, soak or lubricate it – this can harm the pen.

Important information
- Do not share your pen or needles with anyone else.
- Keep your pen out of the reach of others, especially children.
• Change the place where you inject each day to reduce the risk of developing lumps.
With each new pen, check the flow

Check the flow before your first injection with each new pen. If your pen is already in use, go to ‘Select your dose’, step H.

Turn the dose selector until the flow check symbol lines up with the pointer.
Hold the pen with the needle pointing up. Tap the cartridge gently with your finger a few times. This will make any air bubbles collect at the top of the cartridge.
Keep the needle pointing up and press the dose button until 0 mg lines up with the pointer.

A drop of liraglutide should appear at the needle tip. If no drop appears, repeat steps E to G up to four times.

If there is still no drop of liraglutide, change the needle and repeat steps E to G once more.

Do not use the pen if a drop of liraglutide still does not appear. This indicates the pen is defective and you must use a new one.

If you have dropped your pen against a hard surface or suspect that something is wrong with it, always put on a new disposable needle and check the flow before you inject.

Select your dose

Always check that the pointer lines up with 0 mg.

Turn the dose selector until your needed dose lines up with the pointer (0.6 mg, 1.2 mg or 1.8 mg).

If you selected a wrong dose by mistake, simply change it by turning the dose selector backwards or forwards until the right dose lines up with the pointer.

Be careful not to press the dose button when turning the dose selector backwards, as liraglutide may come out.

If the dose selector stops before your needed dose lines up with the pointer, there is not enough liraglutide left for a full dose. Then you can either:

Split your dose into two injections:
Turn the dose selector in either direction until 0.6 mg or
1.2 mg lines up with the pointer. Inject the dose. Then prepare a new pen for injection and inject the remaining number of mg to complete your dose.

You may only split your dose between your current pen and a new pen if trained or advised by your healthcare professional. Use a calculator to plan the doses. If you split the dose wrong, you may inject too much or too little liraglutide.

Inject the full dose with a new pen:
If the dose selector stops before 0.6 mg lines up with the pointer, prepare a new pen and inject the full dose with the new pen.

Do not try to select other doses than 0.6 mg, 1.2 mg or 1.8 mg. The numbers in the display must line up precisely with the pointer to ensure that you get the correct dose.
The dose selector clicks when you turn it. Do not use these clicks to select your dose.
Do not use the cartridge scale to measure how much liraglutide to inject – it is not accurate enough.
Inject your dose

Insert the needle into your skin using the injection technique shown by your doctor or nurse. Then follow the instructions below:

Press the dose button to inject until 0 mg lines up with the pointer. Be careful not to touch the display with your other fingers or press the dose selector sideways when you inject. This is because it may block the injection.
Keep the dose button pressed down and leave the needle under the skin for at least 6 seconds. This is to make sure that you get your full dose.

Pull out the needle.
After that, you may see a drop liraglutide at the needle tip.
This is normal and does not affect your dose.
Guide the needle tip into the outer needle cap without touching the needle or the outer needle cap.
When the needle is covered, carefully push the outer needle cap completely on. Then unscrew the needle.
Dispose of it carefully and put the pen cap back on.

When the pen is empty, carefully dispose of it without a needle attached. Please dispose of the pen and needle in accordance with local requirements.

Always remove the needle after each injection, and store your pen without a needle attached.

This reduces the risk of contamination, infection, leakage of liraglutide, blocked needles and inaccurate dosing.

Caregivers must be very careful when handling used needles – to prevent needle injury and cross-infection.