MOUNJARO 2.5 mg Roztwór do wstrzykiwań w predefiniowanej penie

Treść ulotki

1. Mounjaro 2.5 mg injectable solution in pre-filled pen, 5 mg injectable solution in pre-filled pen, 7.5 mg injectable solution in pre-filled pen, 10 mg injectable solution in pre-filled pen, 12.5 mg injectable solution in pre-filled pen, 15 mg injectable solution in pre-filled pen
   1. What is Mounjaro and what is it used for
   2. What you need to know before using Mounjaro
   3. How to use Mounjaro
   4. Possible side effects
   5. How to store Mounjaro
   6. Content of the pack and other information
2. Mounjaro 2.5 mg injectable solution in a vial, 5 mg injectable solution in a vial, 7.5 mg injectable solution in a vial, 10 mg injectable solution in a vial, 12.5 mg injectable solution in a vial, 15 mg injectable solution in a vial
   1. What is Mounjaro and what is it 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
3. Mounjaro 2.5 mg/dose KwikPen injectable solution in prefilled pen, 5 mg/dose KwikPen injectable solution in prefilled pen, 7.5 mg/dose KwikPen injectable solution in prefilled pen, 10 mg/dose KwikPen injectable solution in prefilled pen, 12.5 mg/dose KwikPen injectable solution in prefilled pen, 15 mg/dose KwikPen injectable solution in prefilled pen
   1. What is Mounjaro KwikPen and what is it used for
   2. What you need to know before using 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
4. Mounjaro 2.5 mg/dose KwikPen injectable solution in prefilled pen, 5 mg/dose KwikPen injectable solution in prefilled pen, 7.5 mg/dose KwikPen injectable solution in prefilled pen, 10 mg/dose KwikPen injectable solution in prefilled pen

Mounjaro 2.5 mg injectable solution in pre-filled pen, 5 mg injectable solution in pre-filled pen, 7.5 mg injectable solution in pre-filled pen, 10 mg injectable solution in pre-filled pen, 12.5 mg injectable solution in pre-filled pen, 15 mg injectable solution in pre-filled pen

tirzepatide

Medicinal product subject to additional monitoring. This will allow the rapid identification of new safety information. You can contribute by reporting any adverse effects encountered during the use of this medicinal product. See the end of section 4 for information on how to report adverse effects.

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, nurse or pharmacist. See section 4.

Contents of this leaflet

• 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

1. What is Mounjaro and what is it used for

Mounjaro contains the 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 sugar levels are high.
Mounjaro is also used for the treatment of adults with obesity or overweight (with a BMI of at least
27 kg/m²). Mounjaro influences the regulation of appetite, which may help you eat less food and
reduce body weight.
In type 2 diabetes, Mounjaro is used:

• alone when metformin (another medicine for diabetes) cannot be taken.
• with other medicines for diabetes when these are not sufficient to control blood sugar levels. These other medicines may be medicines taken orally and/or insulin administered by injection.

Mounjaro is used together with diet and exercise also to lose weight and help to keep
weight under control in adults with:

• a BMI equal to or greater than 30 kg/m² (obesity) or
• a BMI of at least 27 kg/m² and 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 apnea" or a history of heart attack, stroke or blood vessel problems).

BMI (Body Mass Index) is a measure of weight in relation to height.
In patients with obstructive sleep apnea (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 that has been given to you by
your doctor, nurse or pharmacist.

2. What you need to know before using 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 digestive problems or food stays in your stomach for longer than normal (including severe gastroparesis).
• you have ever had pancreatitis (inflammation of the pancreas, which can cause severe and persistent pain in the stomach and back).
• you have an eye problem (diabetic retinopathy or macular edema).
• you are using a sulfonylurea (another medicine for diabetes) or insulin for diabetes, as this may cause a lowering of blood sugar levels (hypoglycemia). Your doctor may need to adjust the dose of these other medicines to reduce this risk.

When you start treatment with Mounjaro, some cases may experience fluid loss/dehydration, for example due to vomiting, nausea and/or diarrhea which can cause 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 are going to have surgery with anesthesia, 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 taking, have recently taken or might
take any other medicines.

Pregnancy
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor for
advice before using this medicine. This medicine should not be used during pregnancy
because the effects of this medicine on the unborn child are unknown. Therefore, it is recommended to use
contraceptive measures during the use of this medicine.

Breastfeeding
It is not known whether tirzepatide passes into breast milk. The risk to newborns/infants cannot be
excluded. If you are breastfeeding or planning to breastfeed, talk to your doctor before
using this medicine. You and your doctor will need to decide whether to stop breastfeeding or
delay the use of 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 sulfonylurea or insulin, you may experience low
blood sugar levels (hypoglycemia) which can reduce your ability to concentrate. Avoid
driving or using machines if you experience signs of hypoglycemia, for example headache, drowsiness,
weakness, dizziness, feeling hungry, confusion, irritability, fast heartbeat and
sweating (see section 4). See section 2 “Warnings and precautions” for information
on the increased risk of hypoglycemia. Talk to your doctor for further information.

Mounjaro contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to use Mounjaro

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts about how to use this medicine, consult your doctor or pharmacist.

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 the dose to 7.5 mg, 10 mg, 12.5 mg or 15 mg once a week in increments of 2.5 mg, if necessary. In any case, your doctor will tell you to maintain a specific dose for at least 4 weeks before moving to a higher dose.

Do not change the dose unless your doctor has told you to do so.
Each pen contains a dose of Mounjaro of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg or 15 mg.

Choosing when to use Mounjaro
You can use the pen at any time of the day, regardless of meals. Preferably, the
medicine should be taken on the same day each week. To help you remember when to use
Mounjaro, you can check the day of the week on which you inject the first dose on the packaging with
which the pen is supplied, or mark it on a calendar.
If necessary, you can change the day of your weekly Mounjaro injection, provided that at least 3 days have
passed since the last injection. After choosing a new day of
administration, continue with the administration once a week on that new day.

How to give a Mounjaro injection
Mounjaro is injected under the skin (subcutaneous injection) of the abdominal area (abdomen) at
least 5 cm from the navel or the upper part of the leg (thigh) or the upper part of the
arm. You may need the help of someone else if you want to give the injection in the upper
arm.
If you wish, you can use the same area of the body each week, but make sure to choose a
different injection site within that area. If you are also injecting insulin, choose a different injection site for that injection.
Read the "Instructions for Use" of the pen carefully before using Mounjaro.

Checking blood glucose levels
If you are using Mounjaro with a sulfonylurea or insulin, it is important that you check your blood glucose
levels according to the instructions of 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, tell your doctor immediately. An excessive amount
of this medicine can cause a lowering of blood sugar levels (hypoglycemia) and
cause you to feel unwell or become ill.

If you forget to use Mounjaro
If you forget to inject a dose and

• 4 days or lesshave passed since you should have used Mounjaro, administer it as soon as you remember. Then inject the next dose as usual, on the scheduled day.
• more than 4 dayshave passed since you should have used Mounjaro, skip the missed dose. Then inject the next dose as usual, on the scheduled day.

Do not use a double dose to make up for the missed dose. The minimum time between two doses must be
at least 3 days.

If you stop taking Mounjaro
Do not stop treatment with Mounjaro without consulting your doctor. If you stop treatment
with Mounjaro and have type 2 diabetes, blood sugar levels may increase.
If you have any doubts about 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 everyone will experience them.

Serious side effects
Uncommon(may affect up to 1 in 100 people)

• Inflammation of the pancreas (acute pancreatitis) which can cause severe and persistent pain in the stomach and back. You should seek medical attention immediately if you experience these symptoms.

Rare(may affect up to 1 in 1,000 people)

• Severe allergic reactions (e.g. anaphylactic reaction, angioedema). You should seek medical help immediately 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)

• Nausea
• Diarrhoea
• Stomach pain reported in patients treated for weight management
• Vomiting reported in patients treated for weight management
• Constipation reported in patients treated for weight management

These side effects are usually not serious. Nausea, diarrhoea and vomiting are more common at the beginning
of therapy with tirzepatide, but decrease over time in most patients.

• A low level of blood sugar (hypoglycaemia) is very common when tirzepatide is used with medicines that contain a sulfonylurea and/or insulin. If you are using a sulfonylurea or insulin for type 2 diabetes, you may need to lower the dose of these

medicines while using 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 behave in case of hypoglycaemia.

Common(may affect up to 1 in 10 people)

• A low level of blood sugar (hypoglycaemia) when tirzepatide is used for type 2 diabetes with metformin and a sodium-glucose cotransporter 2 inhibitor (another medicine for 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
• Decreased appetite reported in patients treated for type 2 diabetes
• Stomach pain reported in patients treated for type 2 diabetes
• Vomiting reported in patients treated for type 2 diabetes - this side effect usually decreases over time
• Difficulty digesting food (dyspepsia)
• Constipation reported in patients treated for type 2 diabetes
• Bloated stomach
• Belching
• Flatulence (intestinal gas)
• Acid reflux or heartburn (also called Gastroesophageal Reflux Disease) caused by stomach acid flowing back into the mouth
• Hair loss reported in patients treated for weight management
• Feeling tired
• Reactions at the injection site (e.g. itching or redness)
• Fast pulse
• Increased levels of pancreatic enzymes (such as lipase and amylase) in the blood

Uncommon(may affect up to 1 in 100 people)

• A low level of blood sugar (hypoglycaemia) 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 in patients treated for type 2 diabetes or obstructive sleep apnea with obesity
• Altered sense of taste
• Altered skin sensitivity
• Delayed stomach emptying

Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system indicated 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 packaging and on the pen label 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 IT.
Store in the original packaging to protect the medicine from light.
Mounjaro can be kept outside the refrigerator at a temperature below 30 °C for up to a
maximum of 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 appears cloudy, has
changed colour or contains particles inside.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Mounjaro contains
The active ingredient is tirzepatide.

• Mounjaro 2.5 mg:each pre-filled pen contains 2.5 mg of tirzepatide in 0.5 mL of solution (5 mg/mL).
• Mounjaro 5 mg:each pre-filled pen contains 5 mg of tirzepatide in 0.5 mL of solution (10 mg/mL).
• Mounjaro 7.5 mg:each pre-filled pen contains 7.5 mg of tirzepatide in 0.5 mL of solution (15 mg/mL).
• Mounjaro 10 mg:each pre-filled pen contains 10 mg of tirzepatide in 0.5 mL of solution (20 mg/mL).
• Mounjaro 12.5 mg:each pre-filled pen contains 12.5 mg of tirzepatide in 0.5 mL of solution (25 mg/mL).
• Mounjaro 15 mg:each pre-filled pen contains 15 mg of tirzepatide in 0.5 mL of solution (30 mg/mL).

The other components are disodium hydrogen phosphate heptahydrate (E339), sodium chloride, sodium hydroxide
(for further information see “Mounjaro contains sodium” in paragraph 2); concentrated hydrochloric acid
and water for injections.

Description of the appearance of Mounjaro and contents of the pack
Mounjaro is a clear, injectable solution, from colourless to slightly yellow in a pre-filled pen.
The pre-filled pen has a hidden needle that will automatically insert into the skin when you press the
injection button. The pre-filled pen will retract the needle at the end of the injection.
Each pre-filled pen contains 0.5mL of solution.
The pre-filled pen is for single use only.
Packs of 2 pre-filled pens, 4 pre-filled pens or multi-pack of 12 (3 packs of 4) pre-filled pens. Not all pack sizes may be marketed in your country.

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

Manufacturer
Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019, Sesto Fiorentino, Florence (FI), Italy
Lilly France, 2, rue du Colonel Lilly, 67640 Fegersheim, France
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

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

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

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

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

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency, https://www.ema.europa.eu.

Instructions for use
Mounjaro2.5 mg solution for injection in a pre-filled pen
Mounjaro5 mg solution for injection in a pre-filled pen
Mounjaro7.5 mg solution for injection in a pre-filled pen
Mounjaro10 mg solution for injection in a pre-filled pen
Mounjaro12.5 mg solution for injection in a pre-filled pen
Mounjaro15 mg solution for injection in a pre-filled pen
tirzepatide

Important information you must know before injecting Mounjaro.
Read these instructions for use and the leaflet before you start using the Mounjaro
pre-filled pen (pen) and each time you use a new pen.There may be
new information. This information does not replace a discussion with your doctor, nurse or
pharmacist about your medical condition or treatment.
Talk to your doctor, nurse or pharmacist about how to inject Mounjaro correctly.

• Mounjaro is a single-use pre-filled pen.
• The pen has a hidden needle that will automatically insert into the skin when you press the injection button. The pen will retract the needle at the end of the injection.
• Mounjaro is used 1 time a week.
• Inject only under the skin (subcutaneously).
• You or another person can inject into the abdomen (stomach), upper thigh (leg) or upper arm.
• You may need someone’s help if you want to inject into the upper arm.

Guide to the parts of the pen
Injection
button purple

Top

Locking ring

Indicator

Lock or unlock

Medicine

Bottom

and end
with the needle
Transparent base

Grey cap
at the base

Prepare your Mounjaro injection
Removethe pen from the refrigerator.
Leave the grey cap at the base until you are ready to inject.

Checkthe label of the
pen to make sure you have
the correct medicine and dose
and that it is not
expired.

Inspectthe pen to
make sure it is not
damaged.

Expiry
date
Make sure the medicine:

• is not frozen
• is not cloudy
• is from colourless to slightly yellow
• has no particles

Washyour hands.

Choose the injection site
Your doctor, nurse or pharmacist can help you choose the best injection site for you.
You or another person can inject into the abdomen
(stomach) at least 5 cm from the navel or into the thigh.

Another person can inject into the back of your arm.
Change (rotate) the injection site each week.
You can use the same area of the body, but you must choose a different injection site
within that area.

Point 1Remove the grey cap at the base
Make sure the pen is locked.

Do notunlock the pen until you position the
transparent base against the skin and are ready to
inject.

Removethe grey cap at the base and throw it away.

Do notput the grey cap back on – this
may damage the needle.

Do nottouch the needle.

Point 2Position the transparent base against the skin, then unlock
Positionthe transparent base flat against the skin at the injection site.

Unlockby turning the locking ring.

Point 3Press and hold for up to 10 seconds
Press and holdthe purple injection button.

Feel:

• First click = start of injection
• Second click = injection completed

Grey
plunger You will know the injection is complete when you see the grey plunger.
plunger

After the injection, put the used pen in a sharps disposal container.

Disposing of the used pen

• Throw (dispose of) the pen in a sharps disposal container or as directed by your doctor, nurse or pharmacist. Do notthrow the pens in household waste.
• Do not recycle the sharps disposal container you used.
• Ask your doctor, nurse or pharmacist how to dispose of medicines you no longer use.

Storage and handling

• For storage instructions, see paragraph 5 of the patient information.
• The pen contains glass parts. Handle with care. If the pen falls onto a hard surface, do notuse it. Use a new pen to inject.

Frequently asked questions
What if I see an air bubble in my pen?
Air bubbles are normal.

What if the pen is not at room temperature?
You do not need to warm the pen to room temperature.

What if I unlock the pen and press the purple injection button before removing the
grey cap at the base?
Do notremove the grey cap at the base. Throw the pen away and take a new one.

What if there is a drop of liquid on the tip of the needle when I remove the grey
cap at the base?
A drop of liquid on the tip of the needle is normal. Do nottouch the needle.

Do I need to keep the injection button pressed until the injection is complete?
Not necessarily, but keeping the button pressed can help keep the pen against your skin.

I heard more than 2 clicks during my injection – 2 louder clicks and 1 faint click. Did
I receive the full dose?
Some people may hear a faint click just before the second loud click.
This is normal pen operation. Do notremove the pen from the skin until you hear
the second loud click.

I am not sure my pen worked correctly.
Check to see if you received the dose. The dose was given
correctly if you see the grey plunger. See also point 3
of the instructions.
If you do not see the grey plunger, contact Lilly for
further instructions. Until then, store the pen safely to
avoid accidental injury with the needle.

What if there is a drop of liquid or blood on my skin after the injection?
This is normal. Press a cotton ball or gauze on the injection site. Do notrub the injection site.

Grey
plunger

Other information

• If you have vision problems, do notuse the pen without the help of a person trained to use the Mounjaro pen.

Where can you find more information

• If you have questions or problems with your Mounjaro pen, contact Lilly or your doctor, nurse or pharmacist.

Mounjaro 2.5 mg injectable solution in a vial, 5 mg injectable solution in a vial, 7.5 mg injectable solution in a vial, 10 mg injectable solution in a vial, 12.5 mg injectable solution in a vial, 15 mg injectable solution in a vial

tirzepatide

Medicinal product subject to additional monitoring. This will allow the rapid identification of new safety information. You can contribute by reporting any adverse effects encountered during the use of this medicine. See the end of section 4 for information on how to report adverse effects.

Read this leaflet carefully before you start to use this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, nurse or pharmacist. See section 4.

Contents of this leaflet

• 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

1. What is Mounjaro and what is it used for

Mounjaro contains the 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 sugar levels are high.
Mounjaro is also used for the treatment of adults with obesity or overweight (with a BMI of at least
27 kg/m²). Mounjaro influences the regulation of appetite, which may help you eat less food and
reduce body weight.
In type 2 diabetes, Mounjaro is used:

• alone when metformin (another medicine for diabetes) cannot be taken.
• with other medicines for diabetes when these are not sufficient to control blood sugar levels. These other medicines may be medicines taken orally and/or insulin administered by injection.

Mounjaro is used together with diet and exercise also to lose weight and help to keep
weight under control in adults with:

• a BMI equal to or greater than 30 kg/m² (obesity) or
• a BMI of at least 27 kg/m² and 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 apnea" or a history of heart attack,
stroke or problems with blood vessels).
BMI (Body Mass Index) is a measure of weight in relation to height.
In patients with obstructive sleep apnea (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 that you have been given 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 digestion or food stays in your stomach for longer than normal (including severe gastroparesis).
• you have ever had pancreatitis (inflammation of the pancreas which can cause severe and persistent pain in the stomach and back).
• you have an eye problem (diabetic retinopathy or macular edema).
• you are using a sulfonylurea (another medicine for diabetes) or insulin for diabetes, as this may cause a lowering of your blood sugar level (hypoglycemia). Your doctor may need to adjust the dose of these other medicines to reduce this risk.

When you start treatment with Mounjaro, it is possible that in some cases you may experience fluid loss/dehydration, for example due to vomiting, nausea and/or diarrhea which can cause 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 are going to have surgery with anesthesia, 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 taking, have recently taken or might
take any other medicines.

Pregnancy
If you are pregnant, suspect you are pregnant or are planning to become pregnant ask your doctor for
advice before using this medicine. This medicine should not be used during pregnancy
because the effects of this medicine on the unborn child are unknown. Therefore, it is recommended to use
contraceptive measures during the use of this medicine.

Breast-feeding
It is not known whether tirzepatide passes into breast milk. The risk to newborns/infants cannot be
excluded. If you are breast-feeding or planning to breast-feed, talk to your doctor before
using this medicine. You and your doctor will need to decide whether to stop breast-feeding or
delay the use of 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 sulfonylurea or insulin, you may experience low
blood sugar levels (hypoglycemia) which can reduce your ability to concentrate. Avoid
driving or using machines if you experience signs of hypoglycemia, for example headache, drowsiness,
weakness, dizziness, feeling hungry, confusion, irritability, fast heartbeat and
sweating (see section 4). See section 2 “Warnings and precautions” for information
on the increased risk of hypoglycemia. Talk to your doctor for further information.

Mounjaro contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially “sodium-free”.

3. How to use Mounjaro

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts on how to use this medicine consult your doctor or pharmacist.

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 the dose to 7.5 mg, 10 mg, 12.5 mg or 15 mg once a week in increments of 2.5 mg, if necessary. In any case your doctor will tell you to maintain a specific dose for at least 4 weeks before moving to a higher dose.

Do not change the dose unless your doctor has told you to do so.
Each vial contains a dose of Mounjaro of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg or 15 mg.

Choosing when to use Mounjaro
You can use Mounjaro at any time of the day, regardless of meals. Possibly,
the medicine should be taken on the same day each week. To help you remember when to use
Mounjaro, you can mark on a calendar the day of the week you inject the first dose.
If necessary, you can change the day of your weekly Mounjaro injection, as long as
at least 3 days have passed since the last injection. After choosing a new day of
administration, continue with the administration once a week on that new day.

How to inject Mounjaro
Always use Mounjaro exactly as your doctor has told you. Before starting to use Mounjaro,
always read carefully the “Instructions for Use” reported below and talk to your doctor,
nurse or pharmacist if you are not sure how to inject Mounjaro correctly.
Mounjaro is injected under the skin (subcutaneous injection) of the abdominal area (belly) or the
upper part of the leg (thigh) or the upper part of the arm. You may need
the help of someone else if you want to inject into the upper arm. Do notinject
Mounjaro directly into a vein as this would modify its action.
If you wish, you can use the same area of the body each week, but make sure to choose a
different injection site within that area. If you are also injecting insulin, choose a different injection site for that injection. If you are blind or visually impaired, you will need the help of
someone to make the injection.

Instructions for Use

• 1. First wash your hands with water and soap.

• 2. Check that Mounjaro in the vial is clear and from colorless to slightly yellow. Do notuse it if it is frozen, cloudy or has particles.
• 3. Remove the plastic protective cap from the vial, but do not remove the cap. Clean the cap of the vial with a swab soaked in disinfectant and prepare a new syringe. Do notshare or reuse the needle or syringe.
• 4. Draw a small amount of air into the syringe. Insert the needle through the rubber cap at the 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 draw all the solution of Mounjaro from the vial. The vial is filled to allow the administration of a single dose of 0.5 mL of Mounjaro.
• 6. If there are air bubbles in the syringe, gently tap the syringe several times to allow the air bubbles to rise to the surface. Slowly push the plunger until there is no air in the syringe.
• 7. Remove the syringe from the vial cap.
• 8. Before making the injection, disinfect the skin.
• 9. By gently pinching the skin, form a skin fold where you will make the injection.
• 10. Perform the subcutaneous injection, as you have been instructed. Inject all the solution from the syringe to receive a complete dose. After the injection, the needle must remain under the skin for 5 seconds to ensure you receive the full dose.
• 11. Remove the needle from the skin.
• 12. Immediately after each injection, discard the used vial, needle and syringe in a puncture-resistant container or as indicated by your doctor, nurse or pharmacist.

Checking your blood glucose levels
If you are using Mounjaro with a sulfonylurea or insulin, it is important that you check your blood glucose
levels according to the instructions of your doctor, nurse or pharmacist (see paragraph 2
“Warnings and precautions”).

If you use more Mounjaro than you should
If you use more Mounjaro than you should, tell your doctor immediately. An excessive amount
of this medicine can cause a lowering of blood sugar (hypoglycemia) and
cause you to feel unwell or make you feel sick.

If you forget to use Mounjaro
If you forget to inject a dose and

• 4 days or lesshave passed since you should have used Mounjaro, administer it as soon as you remember. Then inject the next dose as usual, on the scheduled day.
• more than 4 dayshave passed since you should have used Mounjaro, skip the missed dose. Then inject the next dose as usual, on the scheduled day.

Do not use a double dose to make up for the missed dose. The minimum time between two doses must
be at least 3 days.

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

• Inflammation of the pancreas (acute pancreatitis) which can cause severe and persistent pain in the stomach and back. You should seek medical attention immediately if you experience these symptoms.

Rare(may affect up to 1 in 1,000)

• Serious allergic reactions (e.g. anaphylactic reaction, angioedema). You should seek medical help immediately 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)

• Nausea
• Diarrhoea
• Stomach pain reported in patients treated for weight management
• Vomiting reported in patients treated for weight management
• Constipation reported in patients treated for weight management

These side effects are usually not serious. Nausea, diarrhoea and vomiting are more common at the beginning
of therapy with tirzepatide, but decrease over time in most patients.

• A low level of blood sugar (hypoglycaemia) is very common when tirzepatide is used with medicines that contain a sulfonylurea and/or insulin for type 2 diabetes. If you are using a sulfonylurea or insulin, you may need to lower the dose of these medicines while using tirzepatide (see section 2 “Warnings and precautions”). Symptoms of low blood sugar can include headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, fast heartbeat and sweating. Your doctor should tell you how to behave in case of hypoglycaemia.

Common(may affect up to 1 in 10 people)

• A low level of blood sugar (hypoglycaemia) when tirzepatide is used for type 2 diabetes with metformin and a sodium-glucose cotransporter 2 inhibitor (another medicine for 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
• Decreased appetite reported in patients treated for type 2 diabetes
• Stomach pain reported in patients treated for type 2 diabetes
• Vomiting reported in patients treated for type 2 diabetes - this side effect usually decreases over time
• Difficulty digesting food (dyspepsia)
• Constipation reported in patients treated for type 2 diabetes
• Bloated stomach
• Belching
• Flatulence (gas)
• Acid reflux or heartburn (also called gastroesophageal reflux disease) caused by acid flowing from the stomach to the mouth
• Hair loss reported in patients treated for weight management
• Feeling tired
• Reactions at the injection site (e.g. itching or redness)
• Fast pulse
• Increased levels of pancreatic enzymes (such as lipase and amylase) in the blood
• Increased levels of calcitonin in the blood in patients treated for weight management

Uncommon(may affect up to 1 in 100 people)

• A low level of blood sugar (hypoglycaemia) 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 in patients treated for type 2 diabetes or obstructive sleep apnea with obesity
• Altered sense of taste
• Altered skin sensation
• Delayed stomach emptying

Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly
through the national reporting system listed in Annex 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 packaging and on the label of the
vial 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 it.
Store in the original packaging to protect the medicine from light.
Mounjaro can be kept outside the refrigerator at a temperature below 30 °C for a maximum of 21 cumulative days and then the vial must be discarded.
Do not use this medicine if you notice that the vial, seal or cap is damaged, or the medicine
appears cloudy, has changed colour or contains particles inside.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Mounjaro contains
The active ingredient is tirzepatide.

• Mounjaro 2.5 mg:each vial contains 2.5 mg of tirzepatide in 0.5 mL of solution (5 mg/mL).
• Mounjaro 5 mg:each vial contains 5 mg of tirzepatide in 0.5 mL of solution (10 mg/mL).
• Mounjaro 7.5 mg:each vial contains 7.5 mg of tirzepatide in 0.5 mL of solution (15 mg/mL).
• Mounjaro 10 mg:each vial contains 10 mg of tirzepatide in 0.5 mL of solution (20 mg/mL).
• Mounjaro 12.5 mg:each vial contains 12.5 mg of tirzepatide in 0.5 mL of solution (25 mg/mL).
• Mounjaro 15 mg:each vial contains 15 mg of tirzepatide in 0.5 mL of solution (30 mg/mL).

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

Description of Mounjaro and contents of the pack
Mounjaro is a clear, injectable solution, from colourless to slightly yellow in a vial.
Each vial contains 0.5 mL of solution.
The vial is for single use only.
Packs of 1 vial, 4 vials, 12 vials, multi-pack of 4 (4 packs of 1)
vials or multi-pack of 12 (12 packs of 1) vials. Not all pack sizes may be marketed in your country.
Needles and syringes are not supplied with this pack.

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, Florence (FI), Italy
Lilly S.A., Avda. de la Industria, 30, 28108 Alcobendas, Madrid, Spain
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

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

България
TP "Eli Lilly Nederland" B.V. - Bulgaria
tel. + 359 2 491 41 40

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

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

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website, https://www.ema.europa.eu.

Mounjaro 2.5 mg/dose KwikPen injectable solution in prefilled pen, 5 mg/dose KwikPen injectable solution in prefilled pen, 7.5 mg/dose KwikPen injectable solution in prefilled pen, 10 mg/dose KwikPen injectable solution in prefilled pen, 12.5 mg/dose KwikPen injectable solution in prefilled pen, 15 mg/dose KwikPen injectable solution in prefilled pen

tirzepatide

Medicinal product subject to additional monitoring. This will allow the rapid identification of new safety information. You can contribute by reporting any adverse effects encountered during the use of this medicine. See the end of section 4 for information on how to report adverse effects.

Read this leaflet carefully before you start using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, nurse or pharmacist. See section 4.

Contents of 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 is Mounjaro KwikPen and what is it used for

Mounjaro contains the 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 sugar levels are high.
Mounjaro is also used for the treatment of adults with obesity or overweight (with a BMI of at least
27 kg/m²). Mounjaro influences the regulation of appetite, which may help you eat less food and to
reduce body weight.
In type 2 diabetes, Mounjaro is used:

• alone when metformin (another medicine for diabetes) cannot be taken.
• with other medicines for diabetes when these are not sufficient to control blood sugar levels. These other medicines may be medicines taken by mouth and/or insulin administered by injection.

Mounjaro is used together with diet and exercise also to lose weight and help to keep
weight under control in adults with:

• a BMI equal to or greater than 30 kg/m² (obesity) or
• a BMI of at least 27 kg/m² and 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 apnea" or a history of heart attack, stroke or blood vessel problems).

BMI (Body Mass Index) is a measure of weight in relation to height.
In patients with obstructive sleep apnea (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 that you have been given by
your doctor, nurse or pharmacist.

2. What you need to know before using 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 digestive problems or food stays in your stomach for longer than normal (including severe gastroparesis).
• you have ever had pancreatitis (inflammation of the pancreas, which can cause severe and persistent stomach and back pain).
• you have an eye problem (diabetic retinopathy or macular edema).
• you are using a sulfonylurea (another medicine for diabetes) or insulin for diabetes, as this may cause a lowering of blood sugar levels (hypoglycemia). Your doctor may need to adjust the dose of these other medicines to reduce this risk.

When you start treatment with Mounjaro, it is possible that in some cases you may experience fluid loss/dehydration, for example due to vomiting, nausea and/or diarrhea, which can cause 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 need to have surgery with anesthesia, 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
as it has not been studied in this age group.

Other medicines and Mounjaro
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might
take any other medicines.

Pregnancy
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor for advice
before using this medicine. This medicine should not be used during pregnancy
as the effects of this medicine on the unborn child are unknown. Therefore, it is recommended to use
contraceptive measures while using this medicine.

Breast-feeding
It is not known whether tirzepatide passes into breast milk. The risk to newborns/infants cannot be
excluded. If you are breast-feeding or planning to breast-feed, talk to your doctor before
using this medicine. You and your doctor will need to decide whether to stop breast-feeding or
delay the use of 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 sulfonylurea or insulin, you may experience low
blood sugar levels (hypoglycemia) which can reduce your ability to concentrate. Avoid
driving or using machines if you experience signs of hypoglycemia, such as headache, drowsiness,
weakness, dizziness, feeling hungry, confusion, irritability, rapid heartbeat and
sweating (see section 4). See section 2 “Warnings and precautions” for information
on the increased risk of hypoglycemia. Talk to your doctor for further information.

Mounjaro KwikPen contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

Mounjaro KwikPen contains benzyl alcohol
This medicine contains 5.4 mg of benzyl alcohol per each dose of 0.6 mL. Benzyl alcohol can
cause allergic reactions.
Ask your doctor, nurse or pharmacist if you are pregnant or breast-feeding or have a
liver or kidney condition. This is because large amounts of benzyl alcohol can accumulate in the
body and cause unwanted effects (such as metabolic acidosis).

3. How to use Mounjaro KwikPen

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts about how to use this medicine, consult your doctor or pharmacist.

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 the dose to 7.5 mg, 10 mg, 12.5 mg or 15 mg once a week in increments of 2.5 mg, if necessary. In any case, your doctor will tell you to maintain a specific dose for at least 4 weeks before moving to a higher dose.

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

Choosing when to use Mounjaro
You can use the pen at any time of the day, regardless of meals. Preferably, the
medicine should be taken on the same day each week. To help you remember when to use
Mounjaro, you can mark it on a calendar.
If necessary, you can change the day of your weekly Mounjaro injection, as long as
at least 3 days have passed since the last injection. After choosing a new day of
administration, continue with the administration once a week on that new day.

How to inject Mounjaro KwikPen
Mounjaro is injected under the skin (subcutaneous injection) of the abdominal area (abdomen) at
least 5 cm from the navel or the upper part of the leg (thigh) or the upper part of the
arm. You may need the help of someone else if you want to inject into the upper
arm.
If you wish, you can use the same area of the body each week, but make sure to choose a
different injection site within that area. If you are also injecting insulin, choose a different injection site for that injection.
Read the "Instructions for Use" of the pen carefully before using Mounjaro KwikPen.

Checking blood glucose levels
If you are using Mounjaro with a sulfonylurea or insulin, it is important that you check your blood glucose
levels according to the instructions of 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, tell your doctor immediately. An excessive amount
of this medicine can cause a lowering of blood sugar levels (hypoglycemia) and
cause you to feel unwell or become ill.

If you forget to use Mounjaro
If you forget to inject a dose and

• 4 days or lesshave passed since you should have used Mounjaro, administer it as soon as you remember. Then inject the next dose as usual, on the scheduled day.
• more than 4 dayshave passed since you should have used Mounjaro, skip the missed dose. Then inject the next dose as usual, on the scheduled day.

Do not use a double dose to make up for the missed dose. The minimum time between two doses must
be at least 3 days.

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

• Inflammation of the pancreas (acute pancreatitis) which can cause severe and persistent pain in the stomach and back. You should seek medical attention immediately if you experience these symptoms.

Rare(may affect up to 1 in 1,000 people)

• Severe allergic reactions (e.g. anaphylactic reaction, angioedema). You should seek medical help immediately 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)

• Nausea
• Diarrhoea
• Stomach pain reported in patients treated for weight management
• Vomiting reported in patients treated for weight management
• Constipation reported in patients treated for weight management

These side effects are usually not serious. Nausea, diarrhoea and vomiting are more common at the beginning
of therapy with tirzepatide, but decrease over time in most patients.

• Low blood sugar (hypoglycaemia) is very common when tirzepatide is used with medicines that contain a sulfonylurea and/or insulin. If you are using a sulfonylurea or insulin for type 2 diabetes, you may need to lower the dose of these medicines while using tirzepatide (see section 2 “Warnings and precautions”). Symptoms of low blood sugar can include headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, fast heartbeat and sweating. Your doctor should tell you how to behave in case of hypoglycaemia.

Common(may affect up to 1 in 10 people)

• Low blood sugar (hypoglycaemia) when tirzepatide is used for type 2 diabetes with metformin and a sodium-glucose cotransporter 2 inhibitor (another medicine for 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
• Decreased appetite reported in patients treated for type 2 diabetes
• Stomach pain reported in patients treated for type 2 diabetes
• Vomiting reported in patients treated for type 2 diabetes - this side effect usually decreases over time
• Difficulty digesting food (dyspepsia)
• Constipation reported in patients treated for type 2 diabetes
• Bloated stomach
• Belching
• Flatulence (gas)
• Acid reflux or heartburn (also called Gastroesophageal Reflux Disease) caused by acid flowing from the stomach to the mouth
• Hair loss reported in patients treated for weight management
• Feeling tired
• Reactions at the injection site (e.g. itching or redness)
• Fast pulse
• Increased levels of pancreatic enzymes (such as lipase and amylase) in the blood
• Increased levels of calcitonin in the 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 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 in patients treated for type 2 diabetes or for obstructive sleep apnea with obesity
• Altered sense of taste
• Altered skin sensation
• Delayed stomach emptying

Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Mounjaro KwikPen

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 packaging and on the pen label 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 IT.
Mounjaro KwikPen can be kept outside the refrigerator at a temperature below 30 °C for up to
a maximum of 30 days after first use and then the pen must be discarded.
Do not use this medicine if you notice that the pen is damaged, or the medicine appears cloudy, has
changed colour or contains particles inside.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Mounjaro KwikPen contains
The active ingredient is tirzepatide.

Mounjaro 2.5 mg/dose KwikPen:Each dose contains 2.5 mg of tirzepatide in 0.6 mL of solution.
Each pre-filled multi-dose pen contains 10 mg of tirzepatide in 2.4 mL (4.17 mg/mL). Each pen
delivers 4 doses of 2.5 mg.

Mounjaro 5 mg/dose KwikPen:Each dose contains 5 mg of tirzepatide in 0.6 mL of solution. Each
pre-filled multi-dose pen contains 20 mg of tirzepatide in 2.4 mL (8.33 mg/mL). Each pen
delivers 4 doses of 5 mg.

Mounjaro 7.5 mg/dose KwikPen:Each dose contains 7.5 mg of tirzepatide in 0.6 mL of solution.
Each pre-filled multi-dose pen contains 30 mg of tirzepatide in 2.4 mL (12.5 mg/mL). Each pen
delivers 4 doses of 7.5 mg.

Mounjaro 10 mg/dose KwikPen:Each dose contains 10 mg of tirzepatide in 0.6 mL of solution. Each
pre-filled multi-dose pen contains 40 mg of tirzepatide in 2.4 mL (16.7 mg/mL). Each pen
delivers 4 doses of 10 mg.

Mounjaro 12.5 mg/dose KwikPen:Each dose contains 12.5 mg of tirzepatide in 0.6 mL of solution.
Each pre-filled multi-dose pen contains 50 mg of tirzepatide in 2.4 mL (20.8 mg/mL). Each pen
delivers 4 doses of 12.5 mg.

Mounjaro 15 mg/dose KwikPen:Each dose contains 15 mg of tirzepatide in 0.6 mL of solution. Each
pre-filled multi-dose pen contains 60 mg of tirzepatide in 2.4 mL (25 mg/mL). Each pen delivers
4 doses of 15 mg.
The other ingredients are disodium hydrogen phosphate heptahydrate (E339), benzyl alcohol (E1519) (for
further information see “Mounjaro KwikPen contains benzyl alcohol” in section 2),
glycerol, phenol, sodium chloride, sodium hydroxide (for further information see “Mounjaro contains
sodium” in section 2), hydrochloric acid concentrated, water for injections.

Description of the appearance of Mounjaro and contents of the pack
Mounjaro is a clear, injectable solution, from colourless to slightly yellow in a pre-filled pen
(KwikPen).
Each KwikPen contains 2.4 mL of injectable solution (4 doses of 0.6 mL) and an excess amount
for priming. Needles are not included.
Packs of 1 and 3 KwikPens.
Not all pack sizes may be marketed in your country.

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, Florence (FI), 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
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder:

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

България
TP "Eli Lilly Nederland" B.V. - Bulgaria
tel. + 359 2 491 41 40

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

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

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website, https://www.ema.europa.eu.

Instructions for use
Multi-dose pre-filled pen

Each pen contains 4 fixed doses, one dose should be taken per week

Mounjaro 2.5 mg/dose KwikPen injectable solution in prefilled pen, 5 mg/dose KwikPen injectable solution in prefilled pen, 7.5 mg/dose KwikPen injectable solution in prefilled pen, 10 mg/dose KwikPen injectable solution in prefilled pen

Mounjaro12.5 mg/dose KwikPen injectable solution in prefilled pen
Mounjaro15 mg/dose KwikPen injectable solution in prefilled pen
tirzepatide
These instructions for use contain information on how to inject Mounjaro KwikPen

Important information you must know before injecting Mounjaro KwikPen.
KwikPen and each time you use a new pen. There may be new information. This information does not replace talking to your doctor, pharmacist or nurse about your medical condition or treatment.
Mounjaro KwikPen is a disposable multi-dose prefilled pen. The pen contains 4 fixed doses, one dose must be taken per week.Inject a single injection per week, subcutaneously (under the skin).
After 4 doses, discard (dispose of) the pen, including any unused medicine. The pen will prevent you from selecting a full dose after administering 4 weekly doses. Do notinject the remaining medicine. Do not transfer medicine from the pen into a syringe.

Do notshare your Mounjaro KwikPen with other people, even if the pen needle has been changed. It could cause a serious infection in others or cause them to get a serious infection from you.
People who are blind or have poor vision should not use the pen without the assistance of a person instructed in using the pen.

Guide to the components
Components of Mounjaro KwikPen
Dose Indicator
Cap Pen body
Cartridge Cartridge
container

Cap clip Plunger Label Window
of dosage
Selector
button
of the dose

Pen needle components
Red internal seal (needles are not included)
Cap Outer needle protection Internal paper
cap
needle

Materials needed to administer the injection
Needle compatible with the KwikPen (if you do not know which pen needle to use, ask your healthcare professional)

• Mounjaro KwikPen
• Needle compatible with the KwikPen (if you do not know which pen needle to use, ask your healthcare professional)
• Swab, gauze or cotton ball
• Sharps disposal container or household container Prepare the Mounjaro KwikPen injection

Step 1:

• Wash your hands with soap and water.

Step 2:

• Remove the pen cap.
• Check the pen and the label. Do notuse the pen if:
• the name of the medicine or the dosage does not match what was prescribed to you.
• the pen is expired (Exp.) or appears damaged.
• the medicine has been frozen, has

particles, is cloudy or has changed color.
Mounjaro should be colorless to
light yellow.

Step 3:

• Clean the red internal seal with a swab.

Step 4:

• Take a new pen needle.Always use a new needle for each injection to help prevent infection and needle blockage.
• Remove the paper protection from the outer needle cap.

Step 5:

• Insert the needle covered by the cap straight into the end of the pen and rotate the needle until it is firmly attached.

Step 6:

• a. Remove the outer needle cap and keep it. It will be reused.
• b. Remove the inner needle cap and discard it.
• a. Capb. Capouter needleinner needle

Step 7:

• Slowly rotate the dose selector button until you hear 2 clicksand see the line

longer in the dose window.
This is the loading position. It can
be corrected by rotating the dose selector
button in both directions until
the loading position aligns
with the dose indicator.

Step 8:

• Hold the pen with the needle pointing upwards.
• Gently tap the cartridge container to collect air bubbles at the top.

Step 9:

• Expel some medicine by pressing the dose selector buttonuntil it stops, then count slowly to 5 while holding down the dose selector button. The symbol must be shown in the dose window. Do notinject.

Loading removes air from the cartridge and
ensures the pen works
correctly. The pen is loaded if a
small amount of medicine comes out of
the tip of the pen needle.

5 sec.

• If you do not see the medicine, repeat steps 7 to 9no more than 2 times.
• If you still do not see the medicine, change the pen needle and repeat steps 7 to 9no more than 1 time.
• If you still do not see the medicine, contact your local Lilly affiliate listed in the patient information leaflet.

Injecting Mounjaro KwikPen
Step 10:

• Choose the injection site
• a.You or another person can inject the medicine into the thigh or the abdominal area (abdomen) at least 5 cm from the navel.
• b.Another person can inject you in the back of the arm.
• Changethe injection site each week. You can use the same area of the body, but you must be sure to choose a different injection site within that area.
• a.Frontb. Back

Step 11:

• Rotate the dose selector button until it stops and the symbol is shown in the dose window. The symbol indicates a full dose.

Step 12:

• a.Insert the needle into the skin.

• b.Inject the medicine by pressing the dose selector buttonuntil it stops then

count slowly to 5 while holding the dose
selector button down.Before removing the
needle, the symbol must be shown in the dose
window.

PRESS

5 sec.

Step 13:

• Remove the needle from the skin. A drop of medicine on the tip of the needle is normal. It will not affect the dose.
• Check that the symbol is present in the dose window. If you see the symbol in the dose window, you have received the full dose. If you do not see the symbol in the dose window, reinsert the needle into the skin and finish the injection. Do notre-select the dose. If you still think you have not received the full dose, do notrestart or repeat the injection. Contact your local Lilly affiliate listed in the patient information leaflet.

After injecting Mounjaro KwikPen
Step 14:

• If you see blood after removing the needle from the skin, gently press on the injection site with a gauze or cotton ball. Do notrub the injection site.

Step 15:

• Carefully replace the outer cap on the needle.

Step 16:

• Unscrew the needle covered by the cap and place it in a sharps disposal container (see “Disposing of Mounjaro KwikPen and pen needles”). Do notstore the pen with the needle attached to prevent leakage, needle blockage and air entering the pen. Step 17:

• Replace the cap on the pen Do notstore the pen without the cap attached.

Storing Mounjaro KwikPen
Unused pens:

• Store unused pensin the refrigeratorbetween 2°C and 8°C.
• Unused pens can be used until the expiration date printed on the label if the pen has been kept in the refrigerator.
• Do notfreeze the pen. Discard the pen if it has been frozen. Used pens:
• You can store the used penat room temperaturebelow 30°C after injection.
• Keep the pen and needles out of the sight and reach of children.
• Dispose of the pen 30 days after first use even if there is still medicine left in the pen.
• Dispose of the pen after receiving 4 weekly doses. Attempting to inject the remaining medicine may result in an incomplete dose even if the pen still contains medicine.

Disposing of Mounjaro KwikPen and pen needles

• Place used pen needles in a sharps disposal container or in a hard plastic container with a secure lid.
• Do notthrow loose pen needles in household waste.
• Dispose of the used pen as instructed by your healthcare professional.
• Ask your healthcare professional about available options for properly disposing of the sharps disposal container.
• Do not recycle the used sharps disposal container.

Frequently Asked Questions

• If you cannot remove the pen cap, gently rotate it back and forth, and then pull it off.
• If you have difficulty pushing the dose selector button:
• pushing the dose selector button more slowly will make the injection easier.
• the needle may be blocked. Insert a new needle and load the pen.
• there may be dust, food or liquids inside the pen. Discard the pen and take a new one.

Further information:
If you have any questions or problems with Mounjaro KwikPen:

• Contact the manufacturer Lilly or your doctor, nurse or pharmacist.

Use Mounjaro KwikPen 1 time a
week
I perform my weekly dose injection on the following
dates:
Note the day of the week you
choose to perform the injection. Perform
the injection on this day every
week (e.g., Monday).
(day/month) (day/month) (day/month) (day/month)

APPENDIX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATION FOR THE VARIATION OF THE TERMS
OF THE MARKETING AUTHORISATION
Scientific conclusions
Taking into account the assessment by the Pharmacovigilance and Risk Assessment Committee (Pharmacovigilance and Risk Assessment Committee, PRAC) of the Periodic Safety Update Report (Periodic Safety Update Report, PSUR) for tirzepatide, the PRAC’s scientific conclusions are as follows:
In light of the available data on dysesthesia from clinical studies, from spontaneous reports that
in some cases show a close temporal relationship, a dechallenge and/or rechallenge positive and in
light of a plausible mechanism of action for dysesthesia, the PRAC considers that a causal relationship
between tirzepatide and dysesthesia is at least a reasonable possibility.
In light of the available data on delayed gastric emptying from clinical studies, from
spontaneous reports that in some cases show a close temporal relationship, a dechallenge and/or
rechallenge positive and in light of a plausible mechanism of action for delayed gastric
emptying, the PRAC considers that a causal relationship between tirzepatide and delayed gastric emptying is
at least a reasonable possibility.
The PRAC concluded that the product information for medicines containing tirzepatide must
be amended accordingly.
Having examined the PRAC recommendation, the Committee for Human Medicinal Products

(Committee for Human Medicinal Products, CHMP) agrees with the related overall conclusions and
with the justification for the recommendation.

Justification for the variation of the terms of the marketing authorisation
Based on the scientific conclusions on tirzepatide, the CHMP considers that the benefit/risk ratio of the medicine containing tirzepatide remains unchanged subject to the proposed changes
to the product information.
The CHMP recommends the variation of the terms of the marketing authorisation.