Label: information for the patient

tirzepatida

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section4 includes information on how to report these adverse effects.

Read this label carefully before starting to use this medicine, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any doubts, consult your doctor, nurse, or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience adverse effects, consult your doctor, nurse, or pharmacist, even if they do not appear in this label. See section4.

Mounjaro contains an active ingredient called tirzepatida and is used to treat adults with type 2 diabetes.2. Mounjaro reduces blood sugar levels only when sugar levels are high.

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

In type2 diabetes, Mounjarois used:

• alone when you cannot take metformin (another diabetes medication).
• or in combination with other diabetes medications when these are not sufficient to control your blood sugar levels. These other medications may be taken orally and/or may be an insulin injection.

Mounjaro is also used in combination with diet and exercise to lose weight and help maintain weight control in adults who have:

-a BMI of 30kg/m² or higher (obesity) or

-a BMI of at least 27kg/m², but less than 30kg/m² (overweight) and health problems related to weight (such as prediabetes, type2 diabetes, high blood pressure, abnormal levels of fat in the blood, respiratory problems during sleep known as "obstructive sleep apnea" or a history of myocardial infarction, stroke, or vascular problems)

The BMI (Body Mass Index) is a measure of your weight in relation to your height.

It is essential that you follow the dietary and physical activity advice provided by your doctor, nurse, or pharmacist.

No use MounjaroKwikPen

• if you are allergic to tirzepatide or any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor, nurse, or pharmacist before starting to use Mounjaro if:

• you have severe problems with digestion of food or food stays in your stomach longer than normal (including severe gastroparesis).
• you have ever had pancreatitis (inflammation of the pancreas, which can cause intense pain in the stomach and back that does not go away).
• you have any eye problems (diabetic retinopathy or macular edema).
• you are taking a sulfonylurea (another diabetes medication) or insulin for diabetes, as it may cause a drop in blood sugar (hypoglycemia). Your doctor may need to change the dose of these medications to reduce this risk.

At the start of treatment with Mounjaro, you may experience in some cases fluid loss/dehydration, such as with vomiting, nausea, and/or diarrhea, which can cause a decrease in kidney function. To avoid dehydration, it is essential to drink plenty of fluids. Contact your doctor if you have any questions or concerns.

Children and adolescents

This medication should not be administered to children and adolescents under 18years because it has not been studied in this age group.

Other medications and Mounjaro

Inform your doctor, nurse, or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. This medication should not be used during pregnancy as its effects on the fetus are unknown. Therefore, it is recommended to use contraceptive methods while using this medication.

Lactation

The effects of tirzepatide on breast milk are unknown. It cannot be ruled out that there may be a risk to newborns/infants. If you are breastfeeding or plan to be, consult your doctor before using this medication. You and your doctor must decide whether to stop breastfeeding or delay the use of Mounjaro.

Driving and operating machinery

It is unlikely that this medication will affect your ability to drive and use machines. However, if you use Mounjaro in combination with a sulfonylurea or insulin, it may cause a low level of blood sugar (hypoglycemia) that may reduce your ability to concentrate. Avoid driving or using machines if you have any signs of low blood sugar, such as headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability,rapid heartbeats, and sweating(see section4). See section2, “Warnings and precautions” for information on the increased risk of having low blood sugar. Consult your doctor for more information.

Mounjaro KwikPen contains sodium

This medication contains less than 1mmol of sodium (23mg) per dose; this is, essentially “sodium-free”.

Mounjaro KwikPen contains benzyl alcohol

This medication contains 5.4 mg of benzyl alcohol in each 0.6 ml dose. Benzyl alcohol may cause allergic reactions. Benzyl alcohol may cause mild local irritation.

Consult your doctor, nurse, or pharmacist if you are pregnant or breastfeeding or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause side effects (known as "metabolic acidosis”).

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to use

• The initial dose is 2.5 mg once a week for four weeks. After four weeks, your doctor will increase the dose to 5 mg once a week.

• Your doctor may increase your dose in increments of 2.5 mg to 7.5 mg, 10 mg, 12.5 mg, or 15 mg once a week if needed. In each case, your doctor will instruct you to remain on a specific dose for at least 4 weeks before moving to a higher dose.

Do not change your dose unless your doctor has instructed you to do so.

Choosing when to use Mounjaro

You can use your pen at any time of day, with or without food. If possible, use it on the same day each week. To help you remember when to use Mounjaro, you can note it in a calendar if you wish.

If necessary, you can change the day of your weekly Mounjaro injection, as long as at least 3 days have passed since your last injection. After selecting a new dosing day, continue with the weekly administration on that new day.

How to inject Mounjaro KwikPen

Mounjaro is injected under the skin (subcutaneously) in the abdominal area at a minimum distance of 5 cm from the navel or in the upper thigh or upper arm. You may need help from another person if you want to inject in the upper arm.

If you want, you can inject in the same area of your body each week. However, in this case, make sure to choose different injection sites within the same area. If you also inject insulin, choose a different injection site for that injection.

Before using Mounjaro KwikPen, read the "Instructions for use" carefully.

Blood glucose control

If you are using Mounjaro with a sulfonylurea or insulin, it is essential to control your blood glucose levels as instructed by your doctor, nurse, or pharmacist (see section 2, "Warnings and precautions").

Using more Mounjaro than you should

If you use more Mounjaro than you should, consult your doctor immediately. Too much medication can cause your blood sugar levels to drop too low (hypoglycemia) and also cause nausea or vomiting.

Missing a dose of Mounjaro

If you forget to inject a dose and,

• have passed 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.
• have passed more than 4 days since you should have used Mounjaro, omit the missed dose. Then inject your next dose as usual on your scheduled day.

Do not inject a double dose to compensate for the missed dose. The minimum time between doses must be at least 3 days.

Stopping treatment with Mounjaro

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

If you have any other questions about using this medication, ask your doctor, nurse, or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects

Rare(may affect up to 1 in 100 people)

-Acute pancreatitis, which could cause severe stomach and back pain that does not go away. Seek immediate medical attention if you experience these symptoms.

Very rare(may affect up to 1 in 10,000 people)

• Severe allergic reactions (e.g., anaphylactic reaction, angioedema). You must seek immediate medical help and inform your doctor if you experience symptoms such as respiratory problems, rapid swelling of the lips, tongue, and/or throat with difficulty swallowing and rapid heartbeats.

Other side effects

Very common(may affect more than 1 in 10 people)

• Nausea
• Diarrhea

These side effects are usually not serious. They are more frequent when tirzepatide is first started, but decrease over time in most patients.

• Hypoglycemia (low blood sugar) is very common when tirzepatide is used with other medicines that contain a sulfonylurea and/or insulin. If you are taking a sulfonylurea or insulin for type 2 diabetes, you may need to have your dose reduced while using tirzepatide (see section 2, “Warnings and precautions”).The symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, rapid heartbeats, and sweating. Your doctor should instruct you on how to treat low blood sugar levels.

Common(may affect up to 1 in 10 people)

• Hypoglycemia (low blood sugar) when tirzepatide is used for type 2 diabetes with metformin along with a sodium-glucose cotransporter 2 (SGLT2) inhibitor (another diabetes medicine)
• Allergic reaction (hypersensitivity) (e.g., hives, itching, and eczema)
• Dizziness reported in patients treated for weight control
• Low blood pressure reported in patients treated for weight control

• Decreased appetite reported in patients treated for type 2 diabetes
• Abdominal pain
• Vomiting – usually resolves over time
• Indigestion (dyspepsia)
• Constipation
• Abdominal bloating
• Belching
• Flatulence
• Reflux or stomach acid (also known as gastroesophageal reflux disease – GERD) – a disease caused by stomach acid rising up into the esophagus

• Hair loss reported in patients treated for weight control
• Fatigue (tiredness)
• Reactions at the injection site (e.g., itching or redness)
• Rapid pulse

• Increased levels of pancreatic enzymes (such as lipase and amylase) in the blood.

Rare(may affect up to 1 in 100 people)

• Hypoglycemia (low blood sugar) when tirzepatide is used with metformin for type 2 diabetes
• Gallstones
• Inflammation of the gallbladder
• Weight loss reported in patients treated for type 2 diabetes
• Pain at the injection site
• Increased levels of calcitonin in the blood.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the pen label and packaging after CAD. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C).Do not freeze.If the pen has frozen, DO NOT USE IT.

Mounjaro KwikPen can be stored without refrigerationbelow30°C for up to 30days after the first use and the pen must be discarded thereafter.

Do not use this medication if you observe that the pen is deteriorated or the medication is cloudy, has color, or contains particles.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Mounjaro KwikPen

The active ingredient is tirzepatide.

Mounjaro 2,5mg/doseKwikPen:Each dose contains 2.5mg of tirzepatide in 0.6ml of solution. Each pre-filled multidose pen contains 10 mg of tirzepatide in 2.4 ml (4.17 mg/ml). Each pen administers 4 doses of 2.5 mg.

Mounjaro 5mg/doseKwikPen:Each dose contains 5mg of tirzepatide in 0.6ml of solution. Each pre-filled multidose pen contains 20 mg of tirzepatide in 2.4 ml (8.33 mg/ml). Each pen administers 4 doses of 5 mg.

Mounjaro 7,5mg/doseKwikPen:Each dose contains 7.5mg of tirzepatide in 0.6ml of solution. Each pre-filled multidose pen contains 30 mg of tirzepatide in 2.4 ml (12.5 mg/ml). Each pen administers 4 doses of 7.5 mg.

Mounjaro 10mg/doseKwikPen:Each dose contains 10mg of tirzepatide in 0.6ml of solution. Each pre-filled multidose pen contains 40 mg of tirzepatide in 2.4 ml (16.7 mg/ml). Each pen administers 4 doses of 10 mg.

Mounjaro 12,5mg/doseKwikPen:Each dose contains 12.5mg of tirzepatide in 0.6ml of solution. Each pre-filled multidose pen contains 50 mg of tirzepatide in 2.4 ml (20.8 mg/ml). Each pen administers 4 doses of 12.5 mg.

Mounjaro 15mg/doseKwikPen:Each dose contains 15mg of tirzepatide in 0.6ml of solution. Each pre-filled multidose pen contains 60 mg of tirzepatide in 2.4 ml (25 mg/ml). Each pen administers 4 doses of 15 mg.

The other components are dihydrogen phosphate monohydrate (E339), benzyl alcohol (E1519) (see section 2 “Mounjaro KwikPen contains benzyl alcohol” for more information), glycerol, phenol, sodium chloride, and sodium hydroxide (see section 2 “Mounjaro contains sodium” for more information); concentrated hydrochloric acid and water for injection preparations.

Appearance of the product and contents of the pack

Mounjaro is a transparent, colourless to slightly yellowish injectable solution in a pre-filled pen (KwikPen).

Each KwikPen contains 2.4 ml of injectable solution (4 doses of 0.6 ml) and excess for priming.

Needles are not included.

Pack sizes of 1 and 3 KwikPens.

Only some pack sizes may be marketed.

Marketing authorisation holder

Eli Lilly Nederland B.V.,Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.

Manufacturer responsible

Eli Lilly Italia S.p.A.,Via Gramsci 731/733, 50019, Sesto Fiorentino, Florence (FI), Italy.

For more information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of this leaflet:April 2024

Other sources of information

Further information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu, and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).