Package leaflet: Mounjaro 2.5 mg solution for injection in pre-filled pen / Mounjaro 5 mg solution for injection in pre-filled pen / Mounjaro 7.5 mg solution for injection in pre-filled pen / Mounjaro 10 mg solution for injection in pre-filled pen / Mounjaro 12.5 mg solution for injection in pre-filled pen / Mounjaro 15 mg solution for injection in pre-filled pen

1. What Mounjaro is and what it is used for

Mounjaro contains an active substance called tirzepatide and is used to treat adults, adolescents and children aged 10 years and above with type 2 diabetes mellitus. Mounjaro reduces the level of sugar in the body only when the levels of sugar are high. Mounjaro can also help prevent heart disease.

Mounjaro is also used to treat adults with obesity or overweight (with BMI of at least 27 kg/m2).
Mounjaro influences appetite regulation, which may help you eat less food and reduce your body weight.

In type 2 diabetes, Mounjaro is used:
- on its own when you can’t take metformin (another diabetes medicine).
- with other medicines for diabetes when they are not enough to control your blood sugar levels.
These other medicines may be medicines taken by mouth and/or insulin given by injection.

Mounjaro is also used together with diet and exercise for weight loss and to help keep the weight under control 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) and weight-related health problems (such as prediabetes, type 2 diabetes, high blood pressure, abnormal levels of fats in the blood, breathing problems during sleep called ‘obstructive sleep apnoea’, impaired heart function 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.

In patients with obstructive sleep apnoea (OSA) and obesity, Mounjaro can be used with or without positive airway pressure (PAP) therapy.

It is important to continue to follow the advice on diet and exercise given to you by your doctor, nurse or pharmacist.

2. What you need to know before you use Mounjaro

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

Warnings and precautions
Talk to your doctor, nurse or pharmacist before using Mounjaro if:
- you have severe problems with food digestion or food remaining in your stomach for longer than normal (including severe gastroparesis).
- you have ever had pancreatitis (inflammation of the pancreas which may cause severe pain in the stomach and back which does not go away).
- you have a problem with your eyes.
- you are using a sulphonylurea (another diabetes medicine) or insulin for your diabetes, as low blood sugar (hypoglycaemia) can occur. Your doctor may need to change your dose of these other medicines to reduce this risk.

When starting treatment with Mounjaro, in some cases you may experience loss of fluids/dehydration, e.g. due to vomiting, nausea and/or diarrhoea, which may lead to a decrease in kidney function. It is important to avoid dehydration by drinking plenty of fluids. Contact your doctor if you have any questions or concerns.

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

Children and adolescents
This medicine can be used in children aged 10 years and older for the treatment of type 2 diabetes. It has only been studied in children with type 2 diabetes who have overweight or obesity when starting treatment.

This medicine should not be given to children under 10 years of age treated for type 2 diabetes and to children and adolescents under 18 years of age for weight management because it has not been studied in these age groups.

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

Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. This medicine should not be used during pregnancy as the effects of this medicine on an unborn child are not known. Therefore, it is recommended to use contraception while using this medicine.

Breast-feeding
Tirzepatide passes into breast milk in very low amounts and is not expected to be absorbed by a breastfed newborn/infant. If you are breast-feeding or are planning to breast-feed, talk to your doctor before using or continuing to use this medicine.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive and use machines. However, if you use Mounjaro in combination with a sulphonylurea 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, e.g. headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, fast heartbeat and sweating (see section 4). See section 2, ‘Warnings and precautions’ for information on increased risk of low blood sugar. Talk to your doctor for further information.

Mounjaro 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 Mounjaro

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

How much to use

Adults
- The starting dose is 2.5 mg once a week for four weeks. After four weeks your doctor will increase your dose to 5 mg once a week.
- Your doctor may increase your dose by 2.5 mg increments to 7.5 mg, 10 mg, 12.5 mg or 15 mg once a week if you need it. In each case your doctor will tell you to stay on a particular dose for at least 4 weeks before going to a higher dose.

Adolescents and children aged 10 to less than 18 years treated for type 2 diabetes
- The starting dose is 2.5 mg once a week for four weeks. After four weeks your doctor will increase your dose to 5 mg once a week.
- Your doctor may increase your dose by 2.5 mg increments to 7.5 mg, and 10 mg once a week if you need it. In each case your doctor will tell you to stay on a particular dose for at least 4 weeks before going to a higher dose.

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

Each pen contains one dose of Mounjaro either 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg.

Choosing when to use Mounjaro
You can use your pen at any time of the day, with or without meals. You should use it on the same day each week if you can. To help you remember, when to use Mounjaro, you may wish to tick the day of the week when you inject your first dose on the box that your pen comes in, or mark it on a calendar.

If necessary, you can change the day of your weekly Mounjaro injection, 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 on that new day.

How to inject Mounjaro
Mounjaro is injected under the skin (subcutaneous injection) of your stomach area (abdomen) at least 5 cm from the belly button or upper leg (thigh) or the back of your upper arm. Someone else should help if you want to inject in the back of your upper arm.

If you want to do so, you can use the same area of your body each week. But be sure to choose a different injection site within that area. If you also inject insulin choose a different injection site for that injection.

Read the “Instructions for Use” for the pen carefully before using Mounjaro. If you are below 18 years of age, a caregiver may give you your Mounjaro injection or you may self-inject if your doctor determines that it is appropriate.

Testing blood glucose levels
If you are using Mounjaro with a sulphonylurea or insulin, it is important that you test your blood glucose levels as instructed by your doctor, nurse or pharmacist (see section 2, ‘Warnings and precautions’).

If you use more Mounjaro than you should
If you use more Mounjaro than you should talk to your doctor immediately. Too much of this medicine may cause low blood sugar (hypoglycaemia) and can make you feel sick or be sick.

If you forget to use Mounjaro
If you forget to inject a dose and,
- it has been 4 days or less since you should have used Mounjaro, use it as soon as you remember. Then inject your next dose as usual on your scheduled day.
- If it has been more than 4 days since you should have used Mounjaro, 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. The minimum time between two doses must be at least 3 days.

If you stop using Mounjaro
Do not stop using Mounjaro without talking with your doctor. If you stop using Mounjaro, and you have type 2 diabetes, your blood sugar levels can increase.

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

4. Possible side effects

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

Serious side effects

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 (e.g. anaphylactic reaction, angioedema). You should get immediate medical help and inform your doctor if you experience symptoms such as breathing problems, rapid swelling of the lips, tongue and/or throat with difficulty swallowing and a fast heartbeat.

Other side effects

Very common (may affect more than 1 in 10 people)
- Feeling sick (nausea)
- Diarrhoea
- Stomach (abdominal) pain reported in patients treated for weight management, in patients with type 2 diabetes with cardiovascular disease, and in adolescents and children treated for type 2 diabetes

Being sick (vomiting) reported in patients treated for weight management, in patients with type 2 diabetes with cardiovascular disease and in adolescents and children treated for type 2 diabetes
Constipation reported in patients treated for weight management, and in patients with type 2 diabetes with cardiovascular disease
Feeling less hungry (decreased appetite) reported in patients with type 2 diabetes with cardiovascular disease
Feeling tired (fatigue) reported in patients with type 2 diabetes with cardiovascular disease

These side effects are usually not severe. Nausea, diarrhoea, and vomiting are most common when first starting tirzepatide but decrease over time in most patients.

Low blood sugar (hypoglycaemia) is very common when tirzepatide is used with medicines that contain a sulphonylurea and/or insulin. If you are using a sulphonylurea or insulin for type 2 diabetes, the dose may need to be lowered while you use tirzepatide (see section 2, ‘Warnings and precautions’). Symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, fast heartbeat and sweating. Your doctor should tell you how to treat low blood sugar.

Common (may affect up to 1 in 10 people)
- Low blood sugar (hypoglycaemia) when tirzepatide is used for type 2 diabetes with both metformin and a sodium-glucose co-transporter 2 inhibitor (another diabetes medicine)
- Low blood sugar (hypoglycaemia) when tirzepatide is used with metformin alone in adolescents and children for type 2 diabetes
- Allergic reaction (hypersensitivity) (e.g., rash, itching, and eczema)
- Dizziness reported in patients treated for weight management
- Low blood pressure reported in patients treated for weight management
- Feeling less hungry (decreased appetite) reported in patients treated for type 2 diabetes
- Stomach (abdominal) pain reported in adult patients treated for type 2 diabetes
- Being sick (vomiting) reported in adult patients treated for type 2 diabetes - this usually decreases over time
- Indigestion (dyspepsia)
- Constipation reported in patients treated for type 2 diabetes
- Bloating of the stomach
- Burping (eructation)
- Gas (flatulence)
- Reflux or heartburn (also called gastroesophageal reflux disease – GERD) -–a disease caused by stomach acid coming up into the tube from your stomach to your mouth
- Hair loss reported in patients treated for weight management
- Feeling tired (fatigue) reported in patients treated for type 2 diabetes, and weight management
- Injection site reactions (e.g. itching or redness)
- Fast pulse
- Increased levels of pancreatic enzymes (such as lipase and amylase) in blood
- Increased calcitonin levels in blood in patients treated for weight management.

Uncommon (may affect up to 1 in 100 people)
- Low blood sugar (hypoglycaemia) when tirzepatide is used with metformin in adults for type 2 diabetes.
- Gallstones
- Inflammation of the gallbladder
- Weight loss reported in patients treated for type 2 diabetes
- Injection site pain
- Increased calcitonin levels in blood in adult patients treated for type 2 diabetes or for OSA with obesity
- Changed sense of taste
- Change in skin sensation
- A delay in the emptying of the stomach

Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. 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 Mounjaro

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 on the 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. If the pen has been frozen, DO NOT USE.
Mounjaro can be stored unrefrigerated below 30 ºC for up to 21 cumulative days and then the pen must be discarded.

Store in the original packaging in order to protect from light.

Do not use this medicine if you notice that the pen is damaged, or the medicine is cloudy, discoloured or has particles in it.

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 Mounjaro contains
The active substance is tirzepatide.
- Mounjaro 2.5 mg: Each pre-filled pen contains 2.5 mg of tirzepatide in 0.5 ml solution (5 mg/ml).
- Mounjaro 5 mg: Each pre-filled pen contains 5 mg of tirzepatide in 0.5 ml solution (10 mg/ml).
- Mounjaro 7.5 mg: Each pre-filled pen contains 7.5 mg of tirzepatide in 0.5 ml solution (15 mg/ml).
- Mounjaro 10 mg: Each pre-filled pen contains 10 mg of tirzepatide in 0.5 ml solution (20 mg/ml).
- Mounjaro 12.5 mg: Each pre-filled pen contains 12.5 mg of tirzepatide in 0.5 ml solution (25 mg/ml).
- Mounjaro 15 mg: Each pre-filled pen contains 15 mg of tirzepatide in 0.5 ml solution (30 mg/ml).

The other ingredients are disodium hydrogen phosphate heptahydrate (E339), sodium chloride, sodium hydroxide (see section 2 under ‘Mounjaro contains sodium’ for further information); concentrated hydrochloric acid and water for injections.

What Mounjaro looks like and contents of the pack
Mounjaro is a clear, colourless to slightly yellow, solution for injection in a pre-filled pen.
The pre-filled pen has a hidden needle which will automatically insert into the skin when the injection button is pressed. The pre-filled pen will retract the needle when the injection is completed.
Each pre-filled pen contains 0.5 ml solution.
The pre-filled pen is for single use only.
Pack sizes of 2 pre-filled pens, 4 pre-filled pens or multipack of 12 (3 packs of 4) pre-filled pens. Not all pack sizes may be available in your country.

Marketing Authorisation Holder
Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands.

Manufacturer
Eli Lilly Italia S.p.A.,Via Gramsci 731/733, 50019, Sesto Fiorentino, Firenze (FI), Italy Lilly France, 2, rue du Colonel Lilly, 67640 Fegersheim, France

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

Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600

България
ТП "Ели Лили Недерланд" Б.В. - България тел. + 359 2 491 41 40

Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111

Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100
Danmark
Eli Lilly Danmark A/S
Tlf.: +45 45 26 60 00

Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500
Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222

Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800
Eesti
Eli Lilly Nederland B.V.
Tel: +372 6 817 280

Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00
Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600

Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 20609 1270

España
Lilly S.A.
Tel: + 34-91 663 50 00

Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00
France
Lilly France
Tél: +33-(0) 1 55 49 34 34

Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600
Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999

România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000
Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10
Ísland
Icepharma hf.
Slovenská republika
Eli Lilly Slovakia s.r.o.

Sími + 354 540 8000

Tel: + 421 220 663 111
Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571

Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000

Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800
Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Tel: +371 67364000

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 for use

Mounjaro 2.5 mg solution for injection in pre-filled pen
Mounjaro 5 mg solution for injection in pre-filled pen
Mounjaro 7.5 mg solution for injection in pre-filled pen
Mounjaro 10 mg solution for injection in pre-filled pen
Mounjaro 12.5 mg solution for injection in pre-filled pen
Mounjaro 15 mg solution for injection in pre-filled pen tirzepatide

Important information you need to know before injecting Mounjaro.

Read this instructions for use and the package leaflet before using your Mounjaro pre-filled pen (pen) and each time you get a new pen. There may be new information. This information does not take the place of talking to your doctor, nurse or pharmacist about your medical condition or treatment.

Talk to your doctor, nurse or pharmacist about how to inject Mounjaro the right way.
- Mounjaro is a single-dose pre-filled pen.
- The pen has a hidden needle which will automatically insert into your skin when the injection button is pressed. The pen will retract the needle when the injection is completed.
- Mounjaro is used 1 time each week.
- Inject under the skin (subcutaneously) only.
- You or another person can inject into your stomach (abdomen), upper leg (thigh) or upper arm.
- You may need help from someone else if you want to inject in your upper arm.

Guide to parts

Preparing to inject Mounjaro

Remove the pen from the refrigerator.
Leave the grey base cap on until you are ready to inject.
Check the pen label to make sure you have the right medicine and dose, and that it has not expired.
Inspect the pen to make sure that it is not damaged.
Make sure the medicine is:
• not frozen
• not cloudy
• colourless to slightly yellow
• does not have particles
Wash your hands.

Choose your injection site

Your doctor, nurse or pharmacist can help you choose the injection site that is best for you.
Expiry
Date
Purple injection button
Lock ring
Indicator
Lock or unlock
Medicine
Clear base
Grey base cap
Bottom and needle end
Top

You or another person can inject the medicine in your stomach (abdomen) at least 5 cm from the belly button or thigh.

Another person should give you the injection in the back of your upper arm.

Change (rotate) your injection site each week.

You may use the same area of your body, but be sure to choose a different injection site in that area.

Step 1
Pull off the grey base cap

Make sure the pen is locked.

Do not unlock the pen until you place the clear base on your skin and are ready to inject.

Pull the grey base cap straight off and throw it away.

Do not put the grey base cap back on – this could damage the needle.

Do not touch the needle.

Step 2
Place clear base on skin, then unlock
Place the clear base flat against your skin at the injection site.

Unlock by turning the lock ring.

Clear base
Grey base cap

Step 3
Press and hold up to 10 seconds
Press and hold the purple injection button.

Listen for:
• First click = injection started
• Second click = injection completed

You will know your injection is complete when the grey plunger is visible.
After your injection, place the used pen in a sharps disposal container.

Disposal of your used pen

Throw away (dispose of) the pen in a sharps disposal container or as directed by your doctor, nurse or pharmacist. Do not throw away (dispose of) pens in your household waste.

Do not recycle your used sharps disposal container.

Ask your doctor, nurse or pharmacist about how to dispose of medicines you no longer use.

Storage and handling
- For storage instructions refer to section 5 of the patient information leaflet.
- The pen has glass parts. Handle it carefully. If you drop the pen on a hard surface, do not use it.
Use a new pen for your injection.

Commonly asked questions

What if I see air bubbles in my pen?
Air bubbles are normal.

What if my pen is not at room temperature?
It is not necessary to warm the pen to room temperature.

What if I unlock the pen and press the purple injection button before pulling off the grey base cap?
Do not remove the grey base cap. Throw away the pen and get a new pen.

What if there is a drop of liquid on the tip of the needle when I remove the grey base cap?
A drop of liquid on the tip of the needle is normal. Do not touch the needle.

Do I need to hold the injection button down until the injection is complete?
This is not necessary, but it may help you keep the pen steady against your skin.

I heard more than 2 clicks during my injection — 2 loud clicks and 1 soft one. Did I get my complete injection?
Grey
Plunger

Some people may hear a soft click right before the second loud click. That is the normal operation of the pen. Do not remove the pen from your skin until you hear the second loud click.
I am not sure if my pen worked the right way.

Check to see if you have received your dose. Your dose was delivered the right way if the grey plunger is visible. Also, see Step 3 of the instructions.

If you do not see the grey plunger, contact Lilly for further instructions.
Until then, store your pen safely to avoid an accidental needle injury.

What if there is a drop of liquid or blood on my skin after my injection?
This is normal. Press a cotton ball or gauze over the injection site. Do not rub the injection site.

Other information
- If you have vision problems, do not use your pen without help from a person trained to use the Mounjaro pen.

Where to learn more
- If you have questions or problems with your Mounjaro pen, contact Lilly or your doctor, nurse or pharmacist.

Last revised in

Grey
Plunger

Package leaflet: Mounjaro 2.5 mg solution for injection in vial / Mounjaro 5 mg solution for injection in vial / Mounjaro 7.5 mg solution for injection in vial / Mounjaro 10 mg solution for injection in vial / Mounjaro 12.5 mg solution for injection in vial / Mounjaro 15 mg solution for injection in vial

1. First wash your hands with soap and water.

2. Check that the Mounjaro in the vial looks clear and colourless to slightly yellow. Do not use if it is

frozen, cloudy, or has particles in it.

3. Pull off the vial plastic protective cap, but do not remove the stopper. Clean the stopper on the vial

with a swab and prepare a new syringe. Do not share or reuse your needle or syringe.

4. Draw a small amount of air into the syringe. Put the needle through the rubber stopper on top of the

Mounjaro vial and inject the air into the vial.

5. Turn the Mounjaro vial and the syringe upside down and slowly pull the syringe plunger down to

withdraw all the Mounjaro solution from the vial. The vial is filled to enable delivery of a single 0.5 ml dose of Mounjaro.

6. If there are air bubbles in the syringe, tap the syringe gently a few times to let any air bubbles rise

to the top. Slowly push the plunger up until there is no more air in the syringe.
7. Pull the syringe out of the vial stopper.
8. Before you make an injection, clean your skin.
9. Gently pinch and hold a fold of skin where you will inject.
10. Inject under the skin, as you have been instructed. Inject all the solution from the syringe to receive a full dose. After your injection, the needle should stay under your skin for 5 seconds to make sure you receive the full dose.
11. Pull the needle out of your skin.
12. Throw away the vial, used needle and syringe immediately after each injection in a puncture resistant container, or as instructed by your doctor, nurse or pharmacist.

Testing blood glucose levels
If you are using Mounjaro with a sulphonylurea or insulin, it is important that you test your blood glucose levels as instructed by your doctor, nurse or pharmacist (see section 2, ‘Warnings and precautions’).

If you use more Mounjaro than you should
If you use more Mounjaro than you should talk to your doctor immediately. Too much of this medicine may cause low blood sugar (hypoglycaemia) and can make you feel sick or be sick.

If you forget to use Mounjaro
If you forget to inject a dose and,
- it has been 4 days or less since you should have used Mounjaro, use it as soon as you remember. Then inject your next dose as usual on your scheduled day.
- If it has been more than 4 days since you should have used Mounjaro, 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. The minimum time between two doses must be at least 3 days.

If you stop using Mounjaro
Do not stop using Mounjaro without talking with your doctor. If you stop using Mounjaro, and you have type 2 diabetes, your blood sugar levels can increase.

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

4.
Possible side effects

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

Serious side effects

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 (e.g. anaphylactic reaction, angioedema). You should get immediate medical help and inform your doctor if you experience symptoms such as breathing problems, rapid swelling of the lips, tongue and/or throat with difficulty swallowing and a fast heartbeat.

Other side effects

Very common (may affect more than 1 in 10 people)
- Feeling sick (nausea)
- Diarrhoea
- Stomach (abdominal) pain reported in patients treated for weight management, in patients with type 2 diabetes with cardiovascular disease, and in adolescents and children treated for type 2 diabetes
- Being sick (vomiting) reported in patients treated for weight management, in patients with type 2 diabetes with cardiovascular disease, and in adolescents and children treated for type 2 diabetes
- Constipation reported in patients treated for weight management, and in patients with type 2 diabetes with cardiovascular disease
- Feeling less hungry (decreased appetite) reported in patients with type 2 diabetes with cardiovascular disease
- Feeling tired (fatigue) reported in patients with type 2 diabetes with cardiovascular disease

These side effects are usually not severe. Nausea, diarrhoea, and vomiting are most common when first starting tirzepatide but decrease over time in most patients.

Low blood sugar (hypoglycaemia) is very common when tirzepatide is used with medicines that contain a sulphonylurea and/or insulin. If you are using a sulphonylurea or insulin for type 2 diabetes, the dose may need to be lowered while you use tirzepatide (see section 2, ‘Warnings and precautions’). Symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, fast heartbeat and sweating. Your doctor should tell you how to treat low blood sugar.

Common (may affect up to 1 in 10 people)
- Low blood sugar (hypoglycaemia) when tirzepatide is used for type 2 diabetes with both metformin and a sodium-glucose co-transporter 2 inhibitor (another diabetes medicine)
- Low blood sugar (hypoglycaemia) when tirzepatide is used with metformin alone in adolescents and children for type 2 diabetes
- Allergic reaction (hypersensitivity) (e.g., rash, itching, and eczema)
- Dizziness reported in patients treated for weight management
- Low blood pressure reported in patients treated for weight management
- Feeling less hungry (decreased appetite) reported in patients treated for type 2 diabetes
- Stomach (abdominal) pain reported in adult patients treated for type 2 diabetes
- Being sick (vomiting) reported in adult patients treated for type 2 diabetes - this usually decreases over time

Indigestion (dyspepsia)
Constipation reported in patients treated for type 2 diabetes
Bloating of the stomach
Burping (eructation)
Gas (flatulence)
Reflux or heartburn (also called gastroesophageal reflux disease – GERD) - a disease caused by stomach acid coming up into the tube from your stomach to your mouth
Hair loss reported in patients treated for weight management
Feeling tired (fatigue) reported in patients treated for type 2 diabetes, and weight management
Injection site reactions (e.g. itching or redness)
Fast pulse
Increased levels of pancreatic enzymes (such as lipase and amylase) in blood
Increased calcitonin levels in blood in patients treated for weight management.

Uncommon (may affect up to 1 in 100 people)
- Low blood sugar (hypoglycaemia) when tirzepatide is used with metformin in adults for type 2 diabetes.
- Gallstones
- Inflammation of the gallbladder
- Weight loss reported in patients treated for type 2 diabetes
- Injection site pain
- Increased calcitonin levels in blood in adult patients treated for type 2 diabetes or for OSA with obesity
- Changed sense of taste
- Change in skin sensation
- A delay in the emptying of the stomach

Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. 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 Mounjaro

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 vial label and on the 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. If the vial has been frozen, DO NOT USE.
Mounjaro can be stored unrefrigerated below 30 ºC for up to 21 cumulative days and then the vial must be discarded.

Store in the original packaging in order to protect from light.

Do not use this medicine if you notice that the vial, seal or stopper is damaged, or the medicine is cloudy, discoloured or has particles in it.

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 Mounjaro contains
The active substance is tirzepatide.
- Mounjaro 2.5 mg: Each vial contains 2.5 mg of tirzepatide in 0.5 ml solution (5 mg/ml).
- Mounjaro 5 mg: Each vial contains 5 mg of tirzepatide in 0.5 ml solution (10 mg/ml).
- Mounjaro 7.5 mg: Each vial contains 7.5 mg of tirzepatide in 0.5 ml solution (15 mg/ml).
- Mounjaro 10 mg: Each vial contains 10 mg of tirzepatide in 0.5 ml solution (20 mg/ml).
- Mounjaro 12.5 mg: Each vial contains 12.5 mg of tirzepatide in 0.5 ml solution (25 mg/ml).
- Mounjaro 15 mg: Each vial contains 15 mg of tirzepatide in 0.5 ml solution (30 mg/ml).

The other ingredients are disodium hydrogen phosphate heptahydrate (E339), sodium chloride, sodium hydroxide (see section 2 under ‘Mounjaro contains sodium’ for further information); concentrated hydrochloric acid and water for injections.

What Mounjaro looks like and contents of the pack
Mounjaro is a clear, colourless to slightly yellow, solution for injection in a vial.
Each vial contains 0.5 ml solution.
The vial is for single use only.
Pack sizes of 1 vial, 4 vials, 12 vials, multipack containing 4 (4 packs of 1) vials or multipack containing 12 (12 packs of 1) vials. Not all pack sizes may be available in your country.
Needles and syringe are not provided in this pack.

Marketing Authorisation Holder
Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands.

Manufacturer
Eli Lilly Italia S.p.A.,Via Gramsci 731/733, 50019, Sesto Fiorentino, Firenze (FI), Italy Lilly S.A., Avda. de la Industria, 30, 28108 Alcobendas, Madrid, Spain

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

Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600

България
ТП "Ели Лили Недерланд" Б.В. - България тел. + 359 2 491 41 40

Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111

Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100
Danmark
Eli Lilly Danmark A/S
Tlf.: +45 45 26 60 00

Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500
Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222

Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800
Eesti
Eli Lilly Nederland B.V.
Tel: +372 6 817 280
Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00

Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600

Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 20609 1270
España
Lilly S.A.
Tel: + 34-91 663 50 00

Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00
France
Lilly France
Tél: +33-(0) 1 55 49 34 34

Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600
Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999

România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000
Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10
Ísland
Icepharma hf.
Sími + 354 540 8000

Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111
Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571

Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000

Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800
Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Tel: +371 67364000

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.

Package leaflet: Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen

1. What Mounjaro KwikPen is and what it is used for

Mounjaro contains an active substance called tirzepatide and is used to treat adults, adolescents and children aged 10 years and above with type 2 diabetes mellitus. Mounjaro reduces the level of sugar in the body only when the levels of sugar are high. Mounjaro can also help prevent heart disease.

Mounjaro is also used to treat adults with obesity or overweight (with BMI of at least 27 kg/m2).
Mounjaro influences appetite regulation, which may help you eat less food and reduce your body weight.

In type 2 diabetes, Mounjaro is used:
- on its own when you can’t take metformin (another diabetes medicine).
- with other medicines for diabetes when they are not enough to control your blood sugar levels.
These other medicines may be medicines taken by mouth and/or insulin given by injection.

Mounjaro is also used together with diet and exercise for weight loss and to help keep the weight under control 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) and weight-related health problems (such as prediabetes, type 2 diabetes, high blood pressure, abnormal levels of fats in the blood, breathing problems during sleep called ‘obstructive sleep apnoea’, impaired heart function 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.

In patients with obstructive sleep apnoea (OSA) and obesity, Mounjaro can be used with or without positive airway pressure (PAP) therapy.

It is important to continue to follow the advice on diet and exercise given to you by your doctor, nurse or pharmacist.

2. What you need to know before you use Mounjaro KwikPen

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