TRULICITY 0.75mg 1.5mg 3mg 4.5mg solution for injection in pre-filled pen

XPIL (Text-only Patient Information Leaflet)

Source: TRULICITY_PIL_TR044_Jul25_IE-MT.pdf

Note: This XPIL text version is intended for accessibility (screen readers / large print).

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Package leaflet: Information for the patient

Trulicity® 0.75 mg solution for injection in pre-filled pen

Trulicity® 1.5 mg solution for injection in pre-filled pen

Trulicity® 3 mg solution for injection in pre-filled pen

Trulicity® 4.5 mg solution for injection in pre-filled pen

dulaglutide

Read all of this leaflet carefully before you start taking 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.

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Contents of this leaflet:

1. What Trulicity is and what it is used for

2. What you need to know before you use Trulicity

3. How to use Trulicity

4. Possible side effects

5. How to store Trulicity

6. Contents of the pack and other information

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1. What Trulicity is and what it is used for

Trulicity contains an active substance called dulaglutide and is used to lower blood sugar (glucose) in adults and children aged 10 years and above with type 2 diabetes mellitus, and can help prevent heart disease.

Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. When this happens, sugar (glucose) builds up in the blood.

Trulicity is used:

- on its own if your blood sugar is not properly controlled by diet and exercise alone, and you cannot take metformin (another diabetes medicine).

- or with other medicines for diabetes when they are not enough to control your blood sugar levels. These other medicines may be tablets 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.

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2. What you need to know before you use Trulicity

Do not use Trulicity:

- if you are allergic to dulaglutide or any of the other ingredients (see section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Trulicity if:

- you are on dialysis. This medicine is not recommended.

- you have type 1 diabetes (when your body does not produce insulin). This medicine is not suitable.

- you have diabetic ketoacidosis (a complication caused by very low insulin). Symptoms include rapid weight loss, feeling sick or being sick, sweet smell on breath, metallic taste, or unusual odour in urine or sweat.

- you have severe problems with food digestion or slow emptying of the stomach (including gastroparesis).

- you have ever had pancreatitis (inflammation of the pancreas) causing severe pain in stomach and back.

- you are taking a sulphonylurea or insulin. Low blood sugar (hypoglycaemia) can occur. Your doctor may need to adjust your dose.

- you develop symptoms of delayed stomach emptying such as fullness, nausea or vomiting. Report persistent or severe problems.

Other points:

- Tell your doctor if you are having surgery under anaesthesia.

- Dehydration can occur when starting Trulicity, especially with nausea, vomiting or diarrhoea. Drink fluids and contact your doctor if concerned.

Children and adolescents

- Trulicity can be used from 10 years and older.

- Not for children under 10 years.

Other medicines and Trulicity

Trulicity slows stomach emptying, which can affect absorption of other medicines. Tell your doctor or pharmacist if you use, recently used or may use other medicines.

Pregnancy and breast-feeding

- Do not use in pregnancy. Contraception is advised during treatment. Tell your doctor if pregnant or planning pregnancy.

- Do not use if breast-feeding. It is not known if dulaglutide passes into breast milk.

Driving and using machines

Trulicity has little effect on driving. But if used with sulphonylurea or insulin, hypoglycaemia may occur. Avoid driving or using machines if you get symptoms such as dizziness, sweating, or confusion.

Trulicity contains sodium

Each dose contains less than 1 mmol sodium (23 mg), essentially sodium-free.

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3. How to use Trulicity

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are unsure.

Adults

- Starting dose: 0.75 mg once a week (if used alone).

- With other diabetes medicines: usually 1.5 mg once a week.

- If not controlled, your doctor may increase to 3 mg once a week, then 4.5 mg once a week.

Children and adolescents (10 years and older)

- Starting dose: 0.75 mg once a week.

- If not controlled after at least 4 weeks, dose may be increased to 1.5 mg once a week.

Administration

- Each pen contains one weekly dose (0.75 mg, 1.5 mg, 3 mg, or 4.5 mg).

- Inject under the skin (abdomen, thigh, or upper arm if given by another person).

- Can be used any time of day, with or without meals. Try to use the same day each week.

- Rotate injection sites within the chosen area.

Read the “Instructions for Use” leaflet for your pen carefully before injecting.

If you use more Trulicity than you should

Contact your doctor immediately. Too much can lower blood sugar and cause nausea or vomiting.

If you forget a dose

- If ≥3 days before next dose: inject as soon as possible, then continue as normal.

- If <3 days before next dose: skip the missed dose, and continue as normal.

- Do not inject two doses at once.

- You can change your injection day if at least 3 days have passed since your last dose.

If you stop using Trulicity

Do not stop without medical advice. Blood sugar may rise.

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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Rare (up to 1 in 1,000):

- Severe allergic reactions (anaphylaxis, angioedema). Symptoms: swelling of face, lips, mouth, throat, rash, itching, difficulty breathing. Seek urgent medical help.

- Acute pancreatitis (severe stomach and back pain). Seek urgent medical help.

Not known:

- Bowel obstruction (severe constipation with pain, bloating, vomiting). Seek urgent medical help.

Other side effects

Very common (more than 1 in 10):

- Nausea, vomiting, diarrhoea, stomach pain. These usually lessen over time.

- Hypoglycaemia (with metformin, sulphonylurea, or insulin). Symptoms: headache, tiredness, dizziness, hunger, sweating, fast heartbeat, irritability.

Common (up to 1 in 10):

- Hypoglycaemia when used alone, or with metformin and pioglitazone, or with an SGLT2 inhibitor.

- Decreased appetite

- Indigestion, constipation, bloating, flatulence, burping

- Reflux (GERD, heartburn)

- Fatigue

- Increased heart rate

- Slowed electrical activity in heart

Uncommon (up to 1 in 100):

- Injection site reactions (rash, redness)

- Allergic reactions (hives, swelling)

- Dehydration (with nausea, vomiting, diarrhoea)

- Gallstones, inflamed gallbladder

- Taste changes

Rare (up to 1 in 1,000):

- Delayed stomach emptying

Reporting of side effects

Report via:

- Ireland: HPRA Pharmacovigilance (www.hpra.ie)

- Malta: ADR Reporting (www.medicinesauthority.gov.mt/adrportal)

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5. How to store Trulicity

- Keep out of sight and reach of children.

- Do not use after expiry date (last day of month).

- Store in refrigerator (2°C – 8°C). Do not freeze.

- Store in original packaging to protect from light.

- Can be kept at ≤30°C for up to 14 days.

- Do not use if pen is damaged, cloudy, discoloured, or contains particles.

- Dispose of unused pens properly.

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6. Contents of the pack and other information

What Trulicity contains

- Active substance: dulaglutide.

 * 0.75 mg pen: 0.75 mg in 0.5 ml solution

 * 1.5 mg pen: 1.5 mg in 0.5 ml solution

 * 3 mg pen: 3 mg in 0.5 ml solution

 * 4.5 mg pen: 4.5 mg in 0.5 ml solution

- Other ingredients: sodium citrate, citric acid, mannitol, polysorbate 80, water for injections.

What it looks like

- Clear, colourless solution in a pre-filled single-use pen.

- Each pen contains 0.5 ml solution.

- Packs of 2, 4, or 12 pens (3x4). Not all sizes marketed.

Marketing Authorisation Holder

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

Manufacturers

- 0.75 mg and 1.5 mg: Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France

- 3 mg and 4.5 mg: Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019 Sesto Fiorentino, Firenze, Italy

Local representatives

- Ireland: Eli Lilly and Company (Ireland) Limited, Tel: +353-(0)1-661-4377

- Malta: Charles de Giorgio Ltd., Tel: +356-25600-500

This leaflet was last revised in July 2025.

Further information: www.ema.europa.eu

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Reference code: TR044