Eli Lilly and Company (Ireland) Limited
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Mounjaro
XPIL (Text-only Patient Information Leaflet)
Source: Mounjaro_KP_PIL_MO065_Mar2025_IE-MT.pdf
Note: This XPIL text version is intended for accessibility (screen readers / large print).
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Package leaflet: Information for the patient
Mounjaro® 2.5 mg/dose KwikPen® solution for injection in pre-filled pen
Mounjaro® 5 mg/dose KwikPen® solution for injection in pre-filled pen
Mounjaro® 7.5 mg/dose KwikPen® solution for injection in pre-filled pen
Mounjaro® 10 mg/dose KwikPen® solution for injection in pre-filled pen
Mounjaro® 12.5 mg/dose KwikPen® solution for injection in pre-filled pen
Mounjaro® 15 mg/dose KwikPen® solution for injection in pre-filled pen
tirzepatide
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, nurse or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Mounjaro KwikPen is and what it is used for
2. What you need to know before you use Mounjaro KwikPen
3. How to use Mounjaro KwikPen
4. Possible side effects
5. How to store Mounjaro KwikPen
6. Contents of the pack and other information
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1. What Mounjaro KwikPen is and what it is used for
Mounjaro contains an active substance called tirzepatide and is used to treat adults with type 2 diabetes mellitus. Mounjaro reduces the level of sugar in the body only when the levels of sugar are high.
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’ 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.
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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).
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 (diabetic retinopathy or macular oedema).
- 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 taking Mounjaro.
Children and adolescents
This medicine should not be given to children and adolescents under 18 years of age because it has not been studied in this age group.
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 on an unborn child are not known. It is recommended to use contraception while using this medicine.
Breast-feeding
It is unknown whether tirzepatide passes into breast milk. A risk to newborns/infants cannot be ruled out. If you are breast-feeding or are planning to breast-feed, talk to your doctor. You and your doctor should decide if you should stop breast-feeding or delay using Mounjaro.
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, hunger, confusion, irritability, fast heartbeat, sweating.
Mounjaro KwikPen contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
Mounjaro KwikPen contains benzyl alcohol
This medicine contains 5.4 mg benzyl alcohol in each 0.6 ml dose. Benzyl alcohol may cause allergic reactions.
Ask your doctor, nurse or pharmacist for advice if you are pregnant or breast-feeding or if you have a liver or kidney disease. Large amounts of benzyl alcohol can build up and cause side effects (metabolic acidosis).
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3. How to use Mounjaro KwikPen
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
A small amount of medicine may remain in the pen after all doses have been correctly given. Do not try to use any remaining medicine. After administration of four doses, the pen must be properly discarded.
How much to use
- 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 needed. You will stay on each dose for at least 4 weeks before increasing.
Do not change your dose unless your doctor has told you to.
Choosing when to use Mounjaro
You can use your pen at any time of the day, with or without meals. Use it on the same day each week if possible. Mark your calendar if needed.
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 day, continue with once-a-week dosing on that new day.
How to inject Mounjaro KwikPen
Mounjaro is injected under the skin (subcutaneous injection) of your stomach (abdomen) at least 5 cm from the belly button, thigh, or upper arm. You may need help to inject in the upper arm.
You can use the same body area each week, but choose a different injection site within that area. If you also inject insulin, use a different injection site for that injection.
Read the “Instructions for Use” for the pen carefully before using Mounjaro.
Testing blood glucose levels
If you are using Mounjaro with a sulphonylurea or insulin, test your blood glucose levels as instructed by your doctor, nurse or pharmacist.
If you use more Mounjaro than you should
Contact your doctor immediately. Too much may cause hypoglycaemia, nausea, or vomiting.
If you forget to use Mounjaro
- If 4 days or less have passed, inject as soon as you remember and continue as scheduled.
- If more than 4 days have passed, skip the missed dose and take the next one on your usual day.
Do not use a double dose. The minimum time between two doses must be at least 3 days.
If you stop using Mounjaro
Do not stop without consulting your doctor. If you stop and you have type 2 diabetes, your blood sugar levels may increase.
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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): acute pancreatitis (inflamed pancreas causing severe stomach/back pain that does not go away).
- Rare (may affect up to 1 in 1,000): severe allergic reactions (anaphylactic reaction, angioedema) with symptoms such as breathing problems, rapid swelling of lips/tongue/throat, difficulty swallowing, fast heartbeat.
Other side effects
- Very common (may affect more than 1 in 10): nausea, diarrhoea, stomach pain (weight management), vomiting (weight management), constipation (weight management). These are usually not severe and decrease over time.
- Very common: hypoglycaemia when used with sulphonylurea and/or insulin.
- Common (up to 1 in 10): hypoglycaemia with metformin + SGLT2 inhibitor; allergic reaction (rash, itching, eczema); dizziness (weight management); low blood pressure (weight management); decreased appetite (diabetes); stomach pain (diabetes); vomiting (diabetes); indigestion; constipation (diabetes); bloating; burping; flatulence; reflux/heartburn (GERD); hair loss (weight management); fatigue; injection site reactions; fast pulse; increased pancreatic enzymes; increased calcitonin (weight management).
- Uncommon (up to 1 in 100): hypoglycaemia with metformin; gallstones; gallbladder inflammation; weight loss (diabetes); injection site pain; increased calcitonin (diabetes or OSA with obesity); changed taste; altered skin sensation; delayed stomach emptying.
Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. You can also report via:
- Ireland: HPRA Pharmacovigilance (www.hpra.ie)
- Malta: ADR Reporting (https://medicinesauthority.gov.mt/adrportal)
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5. How to store Mounjaro KwikPen
- Keep out of the sight and reach of children.
- Do not use after the expiry date (EXP, last day of month).
- Store in refrigerator (2–8 °C). Do not freeze. Discard if frozen.
- After first use: can be stored unrefrigerated (≤30 °C) for up to 30 days, then discard.
- Do not use if damaged, cloudy, discoloured, or contains particles.
- Do not dispose via wastewater or household waste. Ask your pharmacist how to dispose.
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6. Contents of the pack and other information
What Mounjaro KwikPen contains
- Active substance: tirzepatide
- 2.5 mg/dose: 2.5 mg per 0.6 ml dose. Each pen contains 10 mg/2.4 ml (4 doses).
- 5 mg/dose: 5 mg per 0.6 ml dose. Each pen contains 20 mg/2.4 ml (4 doses).
- 7.5 mg/dose: 7.5 mg per 0.6 ml dose. Each pen contains 30 mg/2.4 ml (4 doses).
- 10 mg/dose: 10 mg per 0.6 ml dose. Each pen contains 40 mg/2.4 ml (4 doses).
- 12.5 mg/dose: 12.5 mg per 0.6 ml dose. Each pen contains 50 mg/2.4 ml (4 doses).
- 15 mg/dose: 15 mg per 0.6 ml dose. Each pen contains 60 mg/2.4 ml (4 doses).
- Other ingredients: disodium hydrogen phosphate heptahydrate (E339), benzyl alcohol (E1519), glycerol, phenol, sodium chloride, sodium hydroxide, concentrated hydrochloric acid, water for injections.
What Mounjaro looks like
- Clear, colourless to slightly yellow solution in pre-filled KwikPen.
- Each pen contains 2.4 ml solution (4 doses of 0.6 ml), plus excess for priming. Needles not included.
- Pack sizes: 1 or 3 pens. Not all sizes marketed.
Marketing Authorisation Holder
Eli Lilly Nederland B.V.
Papendorpseweg 83, 3528 BJ Utrecht
The Netherlands
Manufacturer
Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019 Sesto Fiorentino, Firenze, Italy
Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain
Lilly France, 2 rue du Colonel Lilly, 67640 Fegersheim, France
Millmount Healthcare Limited, Block 7 City North Business Campus, Stamullen, K32 YD60, Ireland
Millmount Healthcare Limited, IDA Science & Technology Park, Mullagharlin, Dundalk, Co. Louth, A91 DET0, Ireland
Local contacts
- Ireland: Eli Lilly and Company (Ireland) Limited. Tel: +353 (0)1 661 4377
- Malta: Charles de Giorgio Ltd. Tel: +356 25600 500
This leaflet was last revised in March 2025.
Other sources of information
Detailed information is available at: www.ema.europa.eu
Code: MO065