IGZELYM 60 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Igzelym, 60 mg, Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Contents of the Package Leaflet
3. What is Igzelym and what is it used for
   1. What is Igzelym
   2. What Igzelym is used for
   3. How Igzelym works
4. Important information before taking Igzelym
   1. When not to take Igzelym:
   2. Warnings and precautions
   3. Children and adolescents
   4. Igzelym with other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Igzelym contains sodium
5. How to take Igzelym
   1. How much to take
   2. Taking Igzelym with other medicines that prevent blood clotting
   3. How to take Igzelym
   4. What to do if you have difficulty swallowing the tablet
   5. What to do if you take more Igzelym than you should
   6. What to do if you forget to take Igzelym
   7. What to do if you stop taking Igzelym
6. Possible side effects
   1. Seek medical help immediately if you experience any of the following – you may need urgent medical attention:
   2. Tell your doctor if you experience:
   3. Other possible side effects
   4. Very common (may affect more than 1 in 10 people):
   5. Common (may affect up to 1 in 10 people):
   6. Uncommon (may affect up to 1 in 100 people):
   7. Frequency not known (cannot be estimated from the available data)
   8. Reporting side effects
7. How to store Igzelym
8. Contents of the pack and other information
   1. What Igzelym contains
   2. What Igzelym looks like and contents of the pack
   3. Marketing authorisation holder and manufacturer
   4. Marketing authorisation holder:
   5. Manufacturer:

Package Leaflet: Information for the Patient

Igzelym, 60 mg, Coated Tablets

Ticagrelor

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

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

Contents of the Package 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 pack 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 Igzelym is used for

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

• a heart attack, more than a year ago. The medicine reduces the likelihood of having another heart attack, stroke, or death due to a heart or blood vessel condition.

How Igzelym works

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

However, platelets can also form clots in narrowed blood vessels in the heart and brain. This can be very dangerous because:

• a clot can completely block the blood flow, which can cause a heart attack (heart muscle attack) 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 that changes in severity (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 the above applies to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking Igzelym, talk to your doctor or pharmacist:

• if you have an increased risk of bleeding due to:
• a 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 are going to have surgery (including dental surgery) at any time while taking Igzelym. This is because of an 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 shortness of breath. Your doctor will decide if further evaluation is needed;
• if you have any liver problems or have had a condition in the past that may have damaged your liver;
• if your blood test shows high levels of uric acid. Tell your doctor or pharmacist if any of the above applies 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 with other medicines

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

Tell your doctor or pharmacist if you are taking any of the following medicines:

• rosuvastatin (used to lower cholesterol levels);
• simvastatin or lovastatin in doses greater than 40 mg per day (used to lower cholesterol levels);
• rifampicin (an antibiotic);
• phenytoin, carbamazepine, and phenobarbital (used to control seizures);
• digoxin (used to treat heart failure);
• cyclosporin (used to weaken the immune system);
• quinidine and diltiazem (used to treat irregular heart rhythms);
• beta-blockers and verapamil (used to treat high blood pressure);
• morphine and other opioids (used to treat severe pain).

Particularly, tell your doctor or pharmacist if you are taking any of the following medicines that increase the risk of bleeding:

• oral anticoagulants, often called blood thinners, including warfarin;
• non-steroidal anti-inflammatory drugs (NSAIDs), often used as painkillers, such as ibuprofen and naproxen;
• selective serotonin reuptake inhibitors (SSRIs), used as antidepressants, such as paroxetine, sertraline, and citalopram;
• other medicines, such as 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), cisapride (used to treat heartburn), and ergot alkaloids (used to treat migraines and headaches).

Also, inform your doctor if you are taking Igzelym and have an increased risk of bleeding if your doctor prescribes fibrinolytic medicines, often called 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, inform your doctor if you are breastfeeding. Your doctor will discuss the benefits and risks of taking Igzelym while breastfeeding.

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

Driving and using machines

Igzelym is unlikely to affect your ability to drive or use machines. However, if you experience dizziness or disorientation while taking Igzelym, be cautious when driving or using machines.

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.

How much to take

• The usual dose of Igzelym is one 60 mg coated tablet twice a day. Continue taking Igzelym for as long as your doctor recommends;
• 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 medicines that prevent blood clotting

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 inform you about the 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 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 ensure you take all the medicine, refill the glass with water, swirl, and drink.

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. 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 recommends. Stopping Igzelym may increase the risk of having another heart attack, stroke, or death due to a heart or blood vessel condition.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

The following side effects may occur while taking Igzelym:

Ticagrelor affects blood clotting, so most side effects are related to bleeding. Bleeding can occur anywhere in the body. Some bleeding is common (e.g., bruising and nosebleeds). Severe bleeding is less common but can be life-threatening.

Seek medical help immediately if you experience any of the following – you may need urgent medical attention:

• Bleeding in the brain or within 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;
• vomiting blood or coffee-ground-like vomit;
• red or black stools (like tar);
• coughing or vomiting blood clots;
• Fainting:
• temporary loss of consciousness due to a sudden decrease in blood flow to the brain (common);
• Thrombotic thrombocytopenic purpura (TTP) symptoms, 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 extreme tiredness or confusion.

Tell your doctor if you experience:

• Shortness of breath (dyspnea) is very common.It may be caused by heart disease or another condition, or it may be a side effect of Igzelym. Dyspnea associated with ticagrelor is usually mild and characterized by sudden, unexpected shortness of breath, often 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;
• constipation;
• rash;
• itching;
• increased pain and swelling of the joints - symptoms of gout;
• dizziness or lightheadedness or blurred vision - symptoms of low blood pressure;
• nosebleeds;
• bleeding after surgery or from cuts and wounds that is more than usual;
• stomach bleeding (ulcer);
• bleeding gums.

Uncommon (may affect up to 1 in 100 people):

• allergic reaction - rash, itching, swelling of the face or lips/tongue, may be signs of an allergic reaction;
• confusion;
• vision disturbances caused by blood in the eye;
• bleeding from the reproductive tract, which is heavier or occurs at a different time than regular menstrual bleeding;
• bleeding into the joints and muscles, causing painful swelling;
• blood in the ear;
• internal bleeding, which can cause dizziness or lightheadedness.

Frequency not known (cannot be estimated from the available data)

• Abnormally low heart rate (usually less than 60 beats per minute)

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system listed in the website: https://smz.ezdrowie.gov.pl

By reporting side effects, you can help provide more information on the safety of this medicine.

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 which is stated on the blister, bottle, and carton after “EXP”. The expiry date refers to the last day of that month.

No special storage precautions are required.

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

6. Contents of the pack and other information

What Igzelym contains

• The active substance is ticagrelor. Each coated tablet contains 60 mg of ticagrelor.
• The other ingredients are: Core: mannitol, calcium hydrogen phosphate dihydrate, maize starch, pregelatinised maize starch, talc, sodium stearyl fumarate.

Coating: hypromellose, talc, titanium dioxide (E 171), glyceryl monocaprylate/caprate, sodium lauryl sulfate, red iron oxide (E 172), black iron oxide (E 172).

What Igzelym looks like and contents of the pack

Coated tablet: the coated tablets are round, biconvex, pink, and marked with “60” on one side and are smooth on the other side, with a diameter of 8.6 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 × 1 or 60 × 1 coated tablets, in a cardboard box;
• a multipack containing 168 × 1 (3 packs of 56 × 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 further information on this medicine, contact the 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