Igzelym

Package leaflet: Information for the patient

Igzelym, 90 mg, film-coated tablets
tikagrelor
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, 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.

Leaflet contents

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 or
• unstable angina (chest pain or discomfort that is not adequately controlled).

The medicine reduces the likelihood of another heart attack, stroke, or death due to heart- or blood vessel-related 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 openings at the site of a cut or damaged blood vessel.

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

• a clot may completely block blood flow – which may cause a heart attack (myocardial infarction) or stroke, or
• a clot may partially block 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 a clot 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 advise 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 cardiac 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 apnea. The doctor will decide whether further evaluation is needed;
• if the patient has any liver disorders or has previously had a condition that could have damaged the liver;
• if blood tests show the patient has high levels of uric acid. Talk to a doctor or pharmacist before taking this 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 epileptic 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), cyproheptadine (used to treat heartburn), ergot alkaloids (used to treat migraines and headaches).

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 the patient is breastfeeding. The doctor will discuss the benefits and risks of using Igzelym during breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and using machines
It is unlikely that Igzelym will impair the ability to drive or operate machinery. However, if dizziness or disorientation 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 as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
What dose should be taken

• The initial dose is two coated tablets taken at the same time (a loading dose of 180 mg). This dose is usually administered in a hospital setting;
• After the initial dose, the usual dose is one coated tablet of 90 mg taken twice daily for a maximum period of 12 months, unless your doctor advises otherwise;
• 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 prevent blood clotting. Your doctor will advise you on the dose to take
(usually between 75 and 150 mg per day).
How to take Igzelym

• Coated tablets may be taken with food or independently of meals.
• Patients can check when they last took an Igzelym coated tablet by looking at the blister pack. The blister contains printed symbols indicating the sun (for morning doses) and the moon (for evening doses). These symbols help patients remember when they last took their 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 is taken, refill the same glass with half a glass of water, swirl and drink. If the patient is being treated in hospital, the crushed tablet may be administered through a nasogastric tube after mixing with water.

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

• If you miss 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 missed dose.

Stopping 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 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, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during treatment with this medicine:
Tikagrelor 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 uncommonly, but may be life-threatening.

Seek immediate medical attention if any of the following symptoms occur – urgent medical help may be needed:

• Intracranial haemorrhage (bleeding into the brain) is an uncommon adverse reaction and may cause symptoms of stroke such as:
  • sudden numbness or weakness in the arms, legs or face, especially on one side of the body;
  • sudden confusion, difficulty speaking or understanding speech;
  • sudden difficulty walking, loss of balance or coordination;
  • sudden dizziness or sudden severe headache with no 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 colouration of urine;
  • vomiting blood or vomiting material that looks like coffee grounds;
  • red or black, tarry stools;
  • coughing 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 tikagrelor is usually mild and characterised by sudden, unexpected breathlessness, typically occurring at rest. It may occur during the first few weeks of treatment and then not recur for many weeks. If breathlessness worsens or persists for a long time, contact a doctor. The doctor will decide whether treatment or additional diagnostic tests are needed.

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

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

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

• bruising;
• headache;
• dizziness or spinning sensation;
• 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. while shaving) and wounds that is heavier 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 caused by 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 (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 of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921 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 to 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 stated on the blister pack, 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 you no longer require. This will help protect the environment.

6. Contents of the pack and other information

What Igzelym contains

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

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

Igzelym is available in:

• A blister pack (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 blisters (with sun/moon symbols), in a cardboard box;
• A unit dose blister pack containing 56 × 1, 60 × 1 or 100 × 1 coated tablets, in a cardboard box;
• A multipack containing 168 × 1 (3 packs of 56 × 1) coated tablets in unit dose blisters, 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 about this medicinal product and its brand names in the European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
Mylan Healthcare Sp. z o.o.
Tel: +48 22 54 66 400