Ticagrelor Farmak

Leaflet accompanying the packaging: information for the user

Ticagrelor Farmak, 90 mg, film-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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Ticagrelor Farmak and what is it used for

What is Ticagrelor Farmak

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

What is Ticagrelor Farmak used for

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

• heart attack (myocardial infarction) or
• unstable angina (chest pain or discomfort which is not well controlled). The medicine reduces the likelihood of having another heart attack, stroke, or death due to a heart or blood vessel condition.

How Ticagrelor Farmak works

Ticagrelor Farmak works by affecting cells called platelets in the blood (also known as thrombocytes). These small blood cells help stop bleeding by clumping together and blocking small openings in injured blood vessels.

• A blood clot can completely block the blood flow - this can cause a heart attack (myocardial infarction) or stroke, or:
• A blood clot can cause partial blockage of the blood vessels leading to the heart - this reduces blood flow to the heart and can cause chest pain with varying intensity (known as unstable angina). Ticagrelor Farmak helps prevent platelets from clumping together, reducing the likelihood of a blood clot forming, which can reduce blood flow.

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2. Important information before taking Ticagrelor Farmak

When not to take Ticagrelor Farmak

• 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 in the brain;
• If the patient has severe liver disease;
• If the patient is 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) Do not take Ticagrelor Farmak if any of the above applies to you. If in doubt, consult a doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking Ticagrelor Farmak, consult a doctor or pharmacist:

• If the patient has an increased risk of bleeding due to:
• a recent serious injury;
• recent surgery (including dental surgery - consult a dentist);
• a condition that affects blood clotting;
• recent bleeding from the stomach or intestines (such as stomach ulcers or intestinal polyps);
• If the patient is going to have surgery (including dental surgery) while taking Ticagrelor Farmak. This is because of an increased risk of bleeding. The doctor may advise stopping the medicine 5 days before the planned surgery;
• If the patient has a slow heart rate (usually less than 60 beats per minute) and does not have a pacemaker;
• If the patient has asthma or other lung diseases or breathing difficulties;
• If the patient develops breathing difficulties such as rapid breathing, slow breathing, or shortness of breath. The doctor will decide if further evaluation is needed;
• If the patient has any liver problems or has had a disease that may have damaged the liver;
• If the patient's blood test shows high levels of uric acid. Consult a doctor or pharmacist before taking this medicine if any of the above applies to you (or if in doubt). If the patient is taking Ticagrelor Farmak and heparin:
• The doctor may take a blood sample for diagnostic tests if they suspect a rare platelet disorder caused by heparin. It is essential to inform the doctor about taking both Ticagrelor Farmak and heparin, as Ticagrelor Farmak may affect the test result.

Children and adolescents

Ticagrelor Farmak is not recommended for children and adolescents under 18 years of age.

Other medicines and Ticagrelor Farmak

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

• rosuvastatin (a medicine used to treat high cholesterol);
• simvastatin or lovastatin in doses greater than 40 mg per day (medicines used to treat high cholesterol);
• 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 heart rhythm disorders);
• beta-blockers and verapamil (used to treat high blood pressure);
• morphine and other opioids (used to treat severe pain)

Particularly, inform 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 medicines (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), cisapride (used to treat heartburn), and ergot alkaloids (used to treat migraines and headaches).

Also, inform your doctor about taking Ticagrelor Farmak and the increased risk of bleeding if your doctor prescribes fibrinolytic medicines, often called clot-dissolving medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding

Ticagrelor Farmak should not be taken during pregnancy or if there is a possibility of becoming pregnant. Women should use appropriate contraceptive methods to avoid becoming pregnant while taking this medicine.

Before taking this medicine, inform your doctor if you are breastfeeding. The doctor will discuss the benefits and risks of taking Ticagrelor Farmak during breastfeeding.

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

Driving and using machines

It is unlikely that Ticagrelor Farmak will affect your ability to drive or use machines. However, if you experience dizziness or disorientation while taking this medicine, be cautious when driving or using machines.

Sodium content

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially 'sodium-free'.

3. How to take Ticagrelor Farmak

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

How much to take

• The starting dose is 2 tablets taken at the same time (loading dose of 180 mg). This dose is usually given in a hospital.
• After the starting dose, the usual dose is one 90 mg tablet taken twice a day for up to 12 months, unless your doctor tells you otherwise.
• It is recommended to take this medicine at the same time every day (e.g., one tablet in the morning and one in the evening).

Taking Ticagrelor Farmak 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 Ticagrelor Farmak

• Tablets can be taken with or without food.
• The patient can check when they last took a tablet of Ticagrelor Farmak 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 to the patient when they took their last dose.

What to do if you have difficulty swallowing the tablet

If you have difficulty swallowing the tablet, it can be crushed and mixed 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 that all the medicine is taken, add another half glass of water, rinse, and drink. If the patient is in the hospital, the tablet can be mixed with water and given through a nasogastric tube.

What to do if you take more Ticagrelor Farmak than you should

If you take more Ticagrelor Farmak than you should, contact a 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 Ticagrelor Farmak

• 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 Ticagrelor Farmak

Do not stop taking Ticagrelor Farmak without talking to your doctor. You should take this medicine regularly and for as long as your doctor tells you. Stopping Ticagrelor Farmak 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, Ticagrelor Farmak can cause side effects, although not everybody gets them.

When taking this medicine, the following side effects may occur:

Ticagrelor Farmak affects blood clotting, and most side effects are related to bleeding. Bleeding can occur in any part of the body.

Some bleeding occurs frequently (e.g., bruising and nosebleeds). Severe bleeding occurs less frequently but can be life-threatening.

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

• Bleeding into 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;
• urine that is pink, red, or brown;
• vomiting blood or coffee-ground-like material;
• stool that is red or black (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 extreme tiredness or confusion.

Tell your doctor if you experience:

• Shortness of breath - occurs very commonly.It may be caused by heart disease or another condition, or it may be a side effect of Ticagrelor Farmak. Shortness of breath associated with Ticagrelor Farmak is usually mild and characterized by sudden, unexpected shortness of breath, usually at rest, which may occur during the first few weeks of treatment and then not occur for many weeks. If shortness of breath worsens or persists, consult a doctor. The doctor will decide if treatment or further 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 due to 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
• Nosebleeds
• Bleeding after surgery or from cuts and wounds (e.g., while shaving) that is more than usual

is more than usual

• Bleeding from the stomach lining (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
• Disorientation (confusion)
• Vision disturbances due to blood in the eye
• Vaginal bleeding that 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 experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

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

5. How to store Ticagrelor Farmak

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 carton and blister after 'EXP'. The expiry date refers to the last day of that month.

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 Ticagrelor Farmak contains

• The active substance is ticagrelor. Each film-coated tablet contains 90 mg of ticagrelor.
• The other ingredients are: Tablet core:mannitol, calcium hydrogen phosphate dihydrate, hydroxypropylcellulose, sodium carboxymethylcellulose, magnesium stearate Coating:hypromellose (6 mPas), titanium dioxide (E 171), talc, macrogol 400, yellow iron oxide (E 172).

What Ticagrelor Farmak looks like and contents of the pack

The tablets are yellow, round, biconvex, about 9.0 mm in diameter and 4.5 mm in height.

Ticagrelor Farmak is available in PVC/PVDC/Aluminum blister packs containing 10 or 14 tablets.

Cartons containing 56, 60, or 100 tablets are available.

Not all pack sizes may be marketed.

Marketing authorization holder

Farmak International Sp. z o.o.

ul. Koszykowa 65

00-667 Warsaw

tel. +48 22 822 93 06

Importer

Farmak International Sp. z o.o.

al. Piłsudskiego 141

92-318 Łódź

This medicine is authorized in the Member States of the European Economic Area under the following names:

Estonia:

Ticagrelor Farmak

Poland:

Ticagrelor Farmak

Date of last revision of the leaflet:

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