Ticagrelor farmak

Package leaflet: Information for the user

Ticagrelor Farmak, 90 mg, film-coated tablets
Ticagrelorum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as 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 Ticagrelor Farmak is and what it is used for
2. What you need to know before taking Ticagrelor Farmak
3. How to take Ticagrelor Farmak
4. Possible side effects
5. How to store Ticagrelor Farmak
6. Contents of the pack and other information

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

What Ticagrelor Farmak is
Ticagrelor Farmak contains an active substance called ticagrelor. It belongs to a group of medicines known as antiplatelet agents.

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

• a heart attack (myocardial infarction), or
• unstable angina (chest pain or discomfort that is not well controlled).

The medicine reduces the likelihood of having another heart attack, stroke, or death due to heart- or blood vessel-related disease.

How Ticagrelor Farmak works
Ticagrelor Farmak affects blood cells called platelets (also known as thrombocytes). These small blood cells help stop bleeding by clumping together and sealing small holes 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 – this could cause a heart attack (of the heart muscle) or stroke, or
• a clot may partially block blood vessels leading to the heart – this reduces blood flow to the heart and may cause chest pain that varies in intensity (called unstable angina).

Ticagrelor Farmak helps prevent platelets from clumping together, thereby reducing the risk of clot formation that could reduce blood flow.

2. Information before taking Ticagrelor Farmak

When not to take Ticagrelor Farmak

• If the patient is allergic to ticagrelor or to 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 Ticagrelor Farmak if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before starting treatment with this medicine.

Warnings and precautions

Talk to a doctor or pharmacist before taking Ticagrelor Farmak:

• 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);
  • a condition affecting blood clotting;
  • recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps);
• If the patient will undergo any surgical procedure (including dental procedures) while taking Ticagrelor Farmak. 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, slowed 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 high 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 Ticagrelor Farmak 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 Ticagrelor Farmak and heparin, as Ticagrelor Farmak may affect the diagnostic test result.

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

Other medicines and Ticagrelor Farmak
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. This is necessary because Ticagrelor Farmak may affect the action of other medicines, and other medicines may affect Ticagrelor Farmak.

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

• rosuvastatin (a medicine used to treat high cholesterol);
• simvastatin or lovastatin at 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);
• 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 your doctor or pharmacist if you are taking any of the following medicines, which increase the risk of bleeding:

• oral anticoagulants, often called blood thinners, 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), cisapride (used to treat heartburn), ergot alkaloids (used to treat migraines and headaches).

You should also inform your doctor that you are taking Ticagrelor Farmak and are at increased risk of bleeding if your doctor prescribes fibrinolytic medicines, often called clot-dissolving agents, such as streptokinase or alteplase.

Pregnancy and breastfeeding
Ticagrelor Farmak 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 pregnancy.

Inform your doctor if you are breastfeeding. Your doctor will discuss the benefits and risks of using Ticagrelor Farmak during breastfeeding.

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

Driving and using machines
It is unlikely that Ticagrelor Farmak will impair the ability to drive or operate machinery. However, if dizziness or confusion occurs while taking this medicine, caution should be exercised when driving or operating machinery.

Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to take Ticagrelor Farmak

This medicine should always be taken as prescribed by your doctor. If in doubt,
contact your doctor or pharmacist.
What dose to take

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

Taking Ticagrelor Farmak with other anticoagulant medicines
Your doctor will usually recommend taking acetylsalicylic acid concomitantly. This is an active substance
present in many medicines used to prevent blood clotting. Your doctor will advise you on the dose to take
(typically between 75 and 150 mg daily).
How to take Ticagrelor Farmak

• Tablets may be taken with or without food.
• You can check when you last took a Ticagrelor Farmak 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, add another half glass of water, swirl the glass, and drink. If the patient is being treated in hospital, the crushed tablet may be administered via a nasogastric tube after dissolving in water.

Taking more Ticagrelor Farmak than prescribed
If you take more Ticagrelor Farmak 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 miss a dose of Ticagrelor Farmak

• 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 Ticagrelor Farmak
Do not stop taking Ticagrelor Farmak without consulting your doctor. You should take this medicine regularly and for as long as your doctor advises. Stopping Ticagrelor Farmak may increase the risk of recurrent 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 effects

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

• Bleeding into the brain or intracranial haemorrhage is an uncommon adverse effect 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 very long time;
  • urine that is pink, red or brown in colour;
  • vomiting blood or material that looks like coffee grounds;
  • stools that are red or black (resembling tar);
  • coughing or vomiting blood clots;
• Fainting
  • temporary loss of consciousness caused by 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 your doctor if the patient experiences:

• Shortness of breath – very common. It may be caused by heart disease or another condition, or it may be an adverse effect of Ticagrelor Farmak. Dyspnoea associated with Ticagrelor Farmak 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 several weeks. If shortness of breath worsens or persists for a long time, contact your doctor. Your doctor will decide whether treatment or additional tests are needed.

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

• Increased uric acid levels in blood (detected in laboratory tests)
• Bleeding due to blood disorders

Common (may affect up to 1 in 10 people)

• Bruising
• Headache
• Feeling dizzy or lightheaded
• Diarrhoea or indigestion
• Nausea
• Constipation
• Rash
• Itching
• Severe joint pain and swelling – symptoms of gout
• Dizziness, lightheadedness or blurred vision – symptoms of low blood pressure
• Nosebleeds
• Bleeding after surgery or from minor cuts (e.g. during shaving) and wounds that are 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
• Disorientation (confusion)
• Visual disturbances caused by presence of blood in the eye
• Vaginal bleeding that is heavier than usual 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C,
02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Ticagrelor Farmak

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following:
"EXP". The expiry date refers to the last day of the stated month.
No special storage conditions apply 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. Such measures will help protect the environment.

6. Contents of the pack and other information

What Ticagrelor Farmak contains

• The active substance is ticagrelor. Each coated tablet contains 90 mg of ticagrelor.
• The other ingredients are:
  Tablet core: mannitol, calcium hydrogen phosphate dihydrate, hydroxypropyl cellulose, sodium croscarmellose, 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
Film-coated tablets, from light yellow to yellow, round, biconvex, with a diameter of approximately 9.0 mm and a height of approximately 4.5 mm.
Ticagrelor Farmak is available in PVC/PVDC/Aluminium blisters containing 10 or 14 tablets.
Cartons contain 56, 60 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Farmak International Sp. z o.o.
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 medicinal product is authorised in the European Economic Area countries under the following names:
Estonia: Ticagrelor Farmak
Poland: Ticagrelor Farmak