Find similiar products:
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on
0800 198 5000.
The product code(s) for this leaflet is: PLGB 14895/0317.
Mounjaro 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg, 15mg solution for injection in pre-filled pen
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
▼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.
1. What Mounjaro is and what it is used for
2. What you need to know before you use Mounjaro
3. How to use Mounjaro
4. Possible side effects
5. How to store Mounjaro
6. Contents of the pack and other information
Mounjaro is a medicine that contains an active substance called tirzepatide.
Mounjaro is used to treat adults with type 2 diabetes mellitus by reducing the level of sugar in the body only when the levels of sugar are high.
Mounjaro is also used for weight loss and weight maintenance in adults. Mounjaro primarily works by regulating your appetite, giving you a sense of satiety (‘fullness’), making you feel less hungry and experience less food cravings. This will help you eat less food and reduce your body weight.
In type 2 diabetes, Mounjaro is used:
It is important to continue to follow the advice on diet and exercise given to you by your doctor, pharmacist or nurse.
Mounjaro is also used together with reduced-calorie diet and increased physical activity for weight loss and to help keep the weight under control in adults, who have:
BMI (Body Mass Index) is a measure of your weight in relation to your height.
Talk to your doctor, pharmacist or nurse before using Mounjaro if:
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.
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.
Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.
This medicine should not be used during pregnancy as the effects of this medicine on an unborn child are not known. 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. It is recommended to use contraception while using this medicine.
If you are a woman with obesity or overweight and are using oral contraceptives, you should consider also using a barrier method of contraception (e.g., a condom) or switching to a non-oral contraceptive method for 4 weeks after starting Mounjaro and for 4 weeks after each increase in dose.
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 before using this medicine. You and your doctor should decide if you should stop breast-feeding or delay using Mounjaro.
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.
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 or pharmacist has told you. Check with your doctor or pharmacist if you are not sure how to use this medicine.
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.
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.
Mounjaro is injected under the skin (subcutaneous injection) of your stomach area (abdomen) or upper leg (thigh) or upper arm. You may need help from someone else if you want to inject in 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 using Mounjaro with a sulphonylurea or insulin, it is important that you test your blood glucose levels as instructed by your doctor, pharmacist or nurse (see section 2, ‘Warnings and precautions’).
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 inject a dose and,
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.
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, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1 000 people)
Very common (may affect more than 1 in 10 people)
*These side effects are usually not severe. They are most common when first starting tirzepatide but decrease over time in most patients.
**Constipation and vomiting are very common when used for weight management, but common when used for type 2 diabetes.
Common (may affect up to 1 in 10 people)
1Fast pulse is a common side effect when used for type 2 diabetes and uncommon when used for weight management.
2Increased levels of amylase is uncommon in weight management.
Uncommon (may affect up to 1 in 100 people)
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 Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 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.
Store in the original packaging in order to protect from light.
Mounjaro can be stored unrefrigerated not above 30 °C for up to 21 cumulative days and then the pen must be discarded.
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.
The active substance is tirzepatide.
The other ingredients are sodium phosphate dibasic heptahydrate, sodium chloride, sodium hydroxide (see section 2 under ‘Mounjaro contains sodium’ for further information); concentrated hydrochloric acid and water for injections.
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 multipacks of 12 (3 packs of 4) pre-filled pens. Not all pack sizes may be available in your country.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in November 2023
MO017