Igzelym

Package leaflet: Information for the patient

Igzelym, 60 mg, film-coated tablets
tikagrelor
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Igzelym is and what it is 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 Igzelym is and what it is used for

What Igzelym is
Igzelym contains the active substance called tikagrelor. It belongs to a group of medicines known as antiplatelet agents.

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

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

How Igzelym works
Igzelym affects blood cells called platelets (also known as thrombocytes). Platelets are very small blood cells that help stop bleeding by clumping together and sealing small holes at the site of cuts or blood vessel damage.

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

• a clot may completely block blood flow – this may cause a heart attack (myocardial infarction) or stroke, or
• a clot may cause partial blockage of blood vessels leading to the heart, reducing blood flow to the heart and possibly causing chest pain that varies in intensity (known as unstable angina).

Igzelym helps prevent platelets from sticking together. This reduces the likelihood of forming clots that could reduce blood flow.

2. Important information before using Igzelym

When not to use Igzelym:

• if the patient is allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6);
• if the patient is currently bleeding;
• if the patient has had a stroke caused by bleeding into the brain;
• if the patient has severe liver disease;
• if the patient is taking any of the following medicines:
  • ketoconazole (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 situations apply. If in doubt, consult a doctor or pharmacist before starting treatment with this medicine.

Warnings and precautions
Before taking Igzelym, consult a doctor or pharmacist:

• if the patient has an increased risk of bleeding due to:
  • recent serious injury;
  • recent surgical procedures (including dental procedures – consult a dentist regarding this);
  • conditions affecting blood clotting;
  • recent gastrointestinal bleeding (e.g. stomach ulcer or intestinal polyps);
• if the patient will undergo any surgical procedure (including dental) at any time during treatment with Igzelym. This is due to an increased risk of bleeding. The doctor may recommend stopping the medicine 5 days before the planned procedure;
• if the patient has a slow heart rate (usually less than 60 beats per minute) and does not have a pacemaker implanted;
• if the patient has asthma or other lung diseases or breathing difficulties;
• if the patient develops breathing problems such as rapid breathing, slow breathing, or apnoea. The doctor will decide whether further evaluation is needed;
• if the patient has any liver disorders or has previously had a disease that could have damaged the liver;
• if blood tests have shown elevated levels of uric acid in the patient. Talk to a doctor or pharmacist before taking the medicine if any of the above situations apply (or if in doubt).

If the patient is taking both Igzelym and heparin:

• the doctor may take a blood sample for diagnostic testing if heparin-induced thrombocytopenia (a rare platelet disorder) is suspected. It is important to inform the doctor about taking both Igzelym and heparin, as Igzelym may affect the results of the diagnostic test.

Children and adolescents
Igzelym is not recommended for use in children and adolescents under 18 years of age.

Igzelym and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. This is necessary because Igzelym may affect the action of other medicines, and other medicines may affect Igzelym. Inform the doctor or pharmacist if the patient is taking any of the following medicines:

• rosuvastatin (a medicine used to lower cholesterol levels);
• simvastatin or lovastatin at doses higher than 40 mg per day (medicines used to lower cholesterol levels);
• rifampicin (an antibiotic);
• phenytoin, carbamazepine, and phenobarbital (used to control seizures);
• digoxin (used to treat heart failure);
• cyclosporine (used to suppress the immune system);
• quinidine and diltiazem (used to treat heart rhythm disorders);
• beta-blockers and verapamil (used to treat high blood pressure);
• morphine and other opioids (used to treat severe pain).

Especially inform the doctor or pharmacist if the patient is taking any of the following medicines, which increase the risk of bleeding:

• oral anticoagulants, often called blood-thinning medicines, including warfarin;
• non-steroidal anti-inflammatory drugs (NSAIDs), commonly 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 ketoconazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (used to treat HIV and AIDS infections), cimetidine (used to treat heartburn), ergot alkaloids (used to treat migraines and headaches).

You should also inform the doctor about taking Igzelym and the associated increased risk of bleeding if the doctor prescribes fibrinolytic medicines, often called clot-dissolving medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding
Igzelym is not recommended during pregnancy or if there is a possibility of becoming pregnant. Women should use appropriate contraceptive methods while taking this medicine to avoid becoming pregnant.
Inform the doctor if you are breastfeeding. The doctor will discuss the benefits and risks of taking Igzelym while breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
It is unlikely that Igzelym will impair the ability to drive or operate machinery. However, if dizziness or confusion occurs during treatment, caution should be exercised when driving or operating machinery.

Igzelym contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Igzelym

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.
What dose should be taken

• The usual dose is one 60 mg coated tablet twice daily. You should continue taking Igzelym for as long as your doctor recommends;
• It is recommended to take the medicine at the same time each 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 an active
substance found in many medicines that help prevent blood clotting. Your doctor will advise you on
the dose to take (usually between 75 and 150 mg daily).
How to take Igzelym

• Coated tablets can be taken with or without food.
• You can check when you last took an Igzelym coated tablet by looking at the blister pack. The blister contains printed symbols showing the sun (for morning doses) and the moon (for evening doses). These symbols help patients remember when they last took a dose.

What to do if you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, it may be crushed and mixed with water as follows:

• Crush the tablet into a fine powder;
• Pour the powder into half a glass of water;
• Mix and drink immediately;
• To ensure the entire dose has been taken, refill the same glass with half a glass of water, swirl and drink. If the patient is being treated in hospital, the tablet may be administered via a nasogastric tube after dissolving in water.

Taking more Igzelym than recommended
If you take more Igzelym than prescribed, contact your doctor immediately or go to hospital.
Bring the medicine packaging with you. There may be an increased risk of bleeding.
If you forget to take Igzelym

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

Stopping Igzelym
Do not stop taking Igzelym without consulting your doctor. You should take this medicine regularly and for as long as your doctor recommends. Stopping Igzelym may increase the risk of another heart attack or stroke, or death due to heart or blood vessel disease.
If you have any further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur during treatment with this medicine:
Ticagrelor affects blood clotting, therefore most adverse reactions are related to bleeding. Bleeding may occur anywhere in the body. Some bleeding events are common (e.g. bruising and nosebleeds). Severe bleeding occurs less commonly, but may be life-threatening.
Contact a doctor immediately if any of the following symptoms occur – urgent medical assistance may be required:

• Intracranial or brain haemorrhage is an uncommon adverse reaction and may cause stroke-like symptoms such as:
• sudden numbness or weakness of the arms, legs, or face, especially if affecting only one side of the body;
• sudden confusion, difficulty speaking or understanding others;
• sudden difficulty walking, loss of balance or coordination;
• sudden dizziness or sudden severe headache without known cause;
  • signs of bleeding such as:
• heavy bleeding or bleeding that is difficult to stop;
• unexpected bleeding or bleeding that lasts a long time;
• pink, red or brown discoloration of urine;
• vomiting blood or vomit that looks like coffee grounds;
• red or black, tarry stools;
• coughing up or vomiting blood clots;
  • fainting:
• temporary loss of consciousness due to a sudden reduction in blood flow to the brain (common);
  • 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 extreme fatigue or disorientation.

Discuss with the doctor if the patient experiences:

• shortness of breath (dyspnoea) – very common. This may be caused by heart disease or another condition, or may be an adverse reaction to Igzelym. Dyspnoea associated with ticagrelor is usually mild and characterized by sudden, unexpected breathlessness, typically occurring at rest; it may appear during the first few weeks of treatment and then not recur for many weeks. If shortness of breath worsens or persists for a long time, contact a doctor. The doctor will decide whether treatment or further diagnostic tests are needed.

Other possible adverse reactions
Very common (may affect more than 1 in 10 people):

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

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

• bruising;
• headache;
• dizziness or vertigo;
• diarrhoea or indigestion;
• nausea;
• constipation;
• rash;
• itching;
• increased joint pain and swelling – symptoms of gout;
• dizziness, lightheadedness or blurred vision – symptoms of low blood pressure;
• nosebleeds;
• bleeding after surgery or from cuts (e.g. during shaving) and wounds, more severe than usual;
• bleeding from the gastric mucosa (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;
• visual disturbances due to presence of blood in the eye;
• genital tract bleeding that is heavier or occurs at a different time than regular menstrual bleeding;
• bleeding into joints and muscles, causing painful swelling;
• blood in the ear;
• internal bleeding, which may cause dizziness or lightheadedness.

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 4921 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Igzelym

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, bottle, and carton after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must 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, corn starch, pregelatinized starch (corn), talc, sodium stearyl fumarate.
  Coating: polyvinyl alcohol, talc, titanium dioxide (E 171), glycerol monokaprylocapronate, sodium lauryl sulfate, iron oxide red (E 172), iron oxide black (E 172).

What Igzelym looks like and contents of the pack
Coated tablet: The coated tablets are round, biconvex, pink, with the inscription "60" on one side and smooth on the other side, with a diameter of 8.6 mm ±5%.

Igzelym is available as:

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 about this medicinal product and its names in the Member States of the European Economic Area, please contact the local representative of the Marketing Authorization Holder:
Mylan Healthcare Sp. z o.o.
Tel: +48 22 54 66 400