Igzelim

Leaflet accompanying the packaging: Patient information

Igzelym, 90 mg, coated tablets

Ticagrelor

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Table of contents of the leaflet

• 1. What is Igzelym and what is it used for
• 2. Important information before taking Igzelym
• 3. How to take Igzelym
• 4. Possible side effects
• 5. How to store Igzelym
• 6. Contents of the packaging and other information

1. What is Igzelym and what is it used for

What is Igzelym

Igzelym contains the active substance ticagrelor. It belongs to a group of medicines called antiplatelet medicines.

What is Igzelym used for

Igzelym, in combination with acetylsalicylic acid (another antiplatelet medicine), is used only in adults who have had:

• myocardial infarction (heart attack) or
• unstable angina (chest pain or discomfort that is not adequately controlled). The medicine reduces the likelihood of having another heart attack or stroke, or dying from a heart or blood vessel-related disease.

How Igzelym works

Igzelym works by affecting cells called platelets in the blood (also known as thrombocytes). Platelets are very small blood cells that help stop bleeding by clumping together and blocking small openings in injured blood vessels.

• However, platelets can also form clots inside blood vessels in the heart and brain. This can be very dangerous because:
• a clot can completely block the flow of blood - this can cause a heart attack (myocardial infarction) or stroke, or
• a clot can cause partial blockage of the blood vessels leading to the heart, reducing blood flow to the heart and causing chest pain of varying intensity (unstable angina).

Igzelym helps prevent platelets from clumping together. This reduces the likelihood of a clot forming, which can reduce blood flow.

2. Important information before taking Igzelym

When not to take Igzelym:

• if you are allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6);
• if you are currently bleeding;
• if you have had a stroke caused by bleeding in the brain;
• if you have severe liver disease;
• if you are taking any of the following medicines:
• ketokonazole (used to treat fungal infections);
• clarithromycin (used to treat bacterial infections);
• nefazodone (an antidepressant);
• ritonavir and atazanavir (used to treat HIV and AIDS infections). Do not take Igzelym if any of these situations apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking Igzelym, tell your doctor or pharmacist:

• if you have an increased risk of bleeding due to:
• recent serious injury;
• recent surgery (including dental surgery - consult your dentist);
• a condition that affects blood clotting;
• recent bleeding from the stomach or intestines (e.g., stomach ulcer or intestinal polyps);
• if you will be having surgery (including dental surgery) at any time while taking Igzelym. This is because of the increased risk of bleeding. Your doctor may advise you to stop taking Igzelym 5 days before the planned surgery;
• if you have a slow heart rate (usually less than 60 beats per minute) and do not have a pacemaker;
• if you have asthma or other lung diseases or breathing difficulties;
• if you develop breathing difficulties such as rapid breathing, slow breathing, or pauses in breathing. Your doctor will decide if further evaluation is needed;
• if you have any liver problems or have had a disease that may have damaged your liver;
• if your blood test shows high levels of uric acid. Tell your doctor or pharmacist if any of these situations apply to you (or if you are unsure).

If you are taking Igzelym and heparin:

• your doctor may take a blood sample for diagnostic tests if they suspect a rare platelet disorder caused by heparin. It is essential to inform your doctor that you are taking both Igzelym and heparin, as Igzelym may affect the test result.

Children and adolescents

Igzelym should not be used in children and adolescents under 18 years of age.

Igzelym and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any you plan to take. This is because Igzelym may affect the way other medicines work, and other medicines may affect Igzelym.

• rosuvastatin (a medicine used to lower cholesterol levels);
• simvastatin or lovastatin in doses greater than 40 mg per day (medicines used to lower cholesterol levels);

Also, tell your doctor about taking Igzelym and the increased risk of bleeding if your doctor prescribes fibrinolytic medicines, also known as clot-dissolving medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding

Igzelym should not be used during pregnancy or if you are planning to become pregnant. While taking Igzelym, women should use appropriate contraceptive methods to avoid becoming pregnant.

Before taking this medicine, tell your doctor if you are breastfeeding. Your doctor will discuss the benefits and risks of taking Igzelym while breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

It is unlikely that Igzelym will affect your ability to drive or use machines. However, if you experience dizziness or disorientation while taking the medicine, be cautious when driving or operating machinery.

Igzelym contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which is essentially sodium-free.

3. How to take Igzelym

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist.

What dose to take

• The starting dose is two coated tablets taken at the same time (a loading dose of 180 mg). This dose is usually given in the hospital;
• After the starting dose, the usual dose is one 90 mg coated tablet taken twice a day for up to 12 months, unless your doctor tells you otherwise;

It is recommended to take the medicine at the same time every day (e.g., one coated tablet in the morning and one in the evening).

Taking Igzelym with other blood-thinning medicines

Your doctor will usually recommend taking acetylsalicylic acid at the same time. This is a substance found in many medicines that prevent blood clotting. Your doctor will tell you what dose to take (usually between 75 and 150 mg per day).

How to take Igzelym

• The coated tablets can be taken with or without food.
• You can check when you last took a coated tablet of Igzelym by looking at the blister pack. The blister pack has prints showing a sun (for morning doses) and a moon (for evening doses). These prints indicate when you took your last dose.

What to do if you have difficulty swallowing the tablet

If you have difficulty swallowing the tablet, you can crush it and mix it with water as follows:

• crush the tablet into a fine powder;
• add the powder to half a glass of water;
• mix and drink immediately;
• to make sure you take all the medicine, refill the glass with water, rinse, and drink. If you are in the hospital, the crushed tablet can be given through a nasogastric tube.

What to do if you take more Igzelym than you should

If you take more Igzelym than you should, contact your doctor or go to the hospital immediately. Take the medicine packaging with you. You may be at risk of bleeding.

What to do if you forget to take Igzelym

• If you forget to take a dose, take the next dose at the usual time.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

What to do if you stop taking Igzelym

Do not stop taking Igzelym without consulting your doctor. You should take the medicine regularly and for as long as your doctor tells you. Stopping Igzelym may increase the risk of having another heart attack or stroke, or dying from a heart or blood vessel-related disease.

4. Possible side effects

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

The following side effects may occur when taking this medicine:

You should immediately contact your doctor if you experience any of the following symptoms - you may need urgent medical attention:

• Bleeding in the brain or inside the skull is an uncommon side effect and may cause stroke-like symptoms, such as:
• sudden numbness or weakness of the arms, legs, or face, especially if it occurs on one side of the body;
• sudden confusion, difficulty speaking or understanding others;
• sudden difficulty walking, loss of balance, or coordination;
• sudden dizziness or severe headache without a known cause;
• Bleeding symptoms, such as:
• heavy or prolonged bleeding;
• unexpected or prolonged bleeding;
• pink, red, or brown urine;
• bloody vomit or vomit that looks like coffee grounds;
• red or black stools (looking like tar);
• coughing or vomiting blood clots;
• Fainting:
• temporary loss of consciousness due to a sudden decrease in blood flow to the brain (occurs frequently);
• Symptoms related to a blood clotting disorder called thrombotic thrombocytopenic purpura (TTP), such as:
• fever and purple spots (called purpura) on the skin or in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained severe fatigue, or confusion.

You should discuss with your doctor if you experience:

• Shortness of breath (dyspnea) occurs very frequently.It may be caused by heart disease or another cause, or it may be a side effect of Igzelym. Dyspnea associated with ticagrelor is usually mild and characterized by sudden, unexpected shortness of breath, typically at rest; it may occur during the first few weeks of treatment and then not occur for many weeks. If dyspnea worsens or persists, contact your doctor. Your doctor will decide if treatment or further diagnostic tests are needed.

Other possible side effects

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

• increased uric acid levels in the blood (found in laboratory tests);
• bleeding caused by blood disorders.

Common (may affect up to 1 in 10 people):

• bruising;
• headache;
• dizziness or lightheadedness;
• diarrhea or indigestion;
• nausea (feeling sick);
• constipation;
• rash;
• itching;
• increased pain and swelling of the joints - symptoms of gout;
• dizziness or lightheadedness or blurred vision - symptoms of low blood pressure;

Other side effects are listed in the full leaflet.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the national reporting system.

5. How to store Igzelym

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

Do not use this medicine after the expiry date stated on the blister, bottle, and carton after "EXP". The expiry date refers to the last day of the month stated.

There are no special storage instructions for this medicine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Igzelym contains

• The active substance is ticagrelor. Each coated tablet contains 90 mg of ticagrelor.
• The other ingredients are: Core: mannitol, calcium hydrogen phosphate dihydrate, maize starch, maize starch paste, talc, sodium stearyl fumarate.
  Coating: polyvinyl alcohol, talc, titanium dioxide (E 171), glycerol monocaprylocaprate, sodium lauryl sulfate, yellow iron oxide (E 172).

What Igzelym looks like and contents of the pack

Coated tablet: the coated tablets are round, biconvex, yellow, and marked with "90" on one side and are smooth on the other side, with a diameter of 9.6 mm ± 5%.

Igzelym is available in:

• blister packs (with sun/moon symbols) containing 14, 56, or 60 coated tablets, in a cardboard box;
• a multipack containing 168 (3 packs of 56) or 180 (3 packs of 60) coated tablets in blister packs (with sun/moon symbols), in a cardboard box;
• single-dose blister packs containing 56 x 1, 60 x 1, or 100 x 1 coated tablets, in a cardboard box;
• a multipack containing 168 x 1 (3 packs of 56 x 1) coated tablets in single-dose blister packs, in a cardboard box;
• bottles containing 30 coated tablets, in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer:

PharOS MT Ltd
HF 62X, Hal Far Industrial Estate
Birzebbugia, BBG3000
Malta
For more information on this medicine, including its names in EU member states, contact your local representative of the marketing authorisation holder:

Mylan Healthcare Sp. z o.o.
Tel: +48 22 54 66 400
Date of last revision of the leaflet:02.03.2023