Mounjaro Kwikpen 7.5Mg/0.6Ml Pre-Filled Pen 1'S (4 Doses/Pen)

 
Mounjaro Kwikpen 7.5Mg/0.6Ml Pre-Filled Pen 1'S (4 Doses/Pen)
Mounjaro is a prescription injection used with diet and exercise to help lower blood sugar in adults with type 2 diabetes.
Tirzepatide (Mounjaro®) Factsheet
Mounjaro KwikPen 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg, 15mg solution for injection in pre-filled pen
Package leaflet: Information for the patient
Mounjaro® 2.5 mg KwikPen® solution for injection in pre-filled pen
Mounjaro® 5 mg KwikPen® solution for injection in pre-filled pen
Mounjaro® 7.5 mg KwikPen® solution for injection in pre-filled pen
Mounjaro® 10 mg KwikPen® solution for injection in pre-filled pen
Mounjaro® 12.5 mg KwikPen® solution for injection in pre-filled pen
Mounjaro® 15 mg 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, pharmacist or nurse.
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, pharmacist or nurse. 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
1. What Mounjaro KwikPen is and what it is used for
What Mounjaro is
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.
What Mounjaro is used for
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.
 
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:
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.
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, pharmacist or nurse 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.
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, pharmacist or nurse if you are using, have recently used or might use any other medicines.
Pregnancy
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.
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 before using this medicine. 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, 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 KwikPen contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
Mounjaro KwikPen contains benzyl alcohol
Each multiple-dose pre-filled pen contains 5.4 mg Benzyl Alcohol [E1519] in each 0.6 ml dose. Benzyl alcohol may cause allergic reactions.
Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).