Ticagrelor teva

Package leaflet: Information for the patient

Ticagrelor Teva, 90 mg, film-coated tablets
Ticagrelor
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

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

Table of contents of the leaflet

1. What is Ticagrelor Teva and what is it used for
2. What you need to know before taking Ticagrelor Teva
3. How to take Ticagrelor Teva
4. Possible side effects
5. How to store Ticagrelor Teva
6. Contents of the pack and other information

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

What Ticagrelor Teva is
Ticagrelor Teva contains an active substance called ticagrelor. It belongs to a group of medicines
known as antiplatelet agents.
Why Ticagrelor Teva is used
Ticagrelor Teva, in combination with acetylsalicylic acid (another antiplatelet medicine), is used
only in adults. This medicine is prescribed for patients who have experienced:
Ticagrelor Teva 90 mg, tablets

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

The medicine reduces the likelihood of another heart attack or stroke, or death due to heart or
blood vessel disease.
How Ticagrelor Teva works
Ticagrelor Teva 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 clots inside diseased blood vessels in the heart and brain. This may be very dangerous because:

• a clot may completely block blood flow – which can lead to 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 causing chest pain that comes and goes (known as unstable angina).

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

2. Important information before using Ticagrelor Teva

When not to take Ticagrelor Teva

• 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 atazanawir (used to treat HIV and AIDS infections).

Do not take Ticagrelor Teva 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 starting Ticagrelor Teva, discuss with your doctor or pharmacist if:

• The patient has an increased risk of bleeding due to:
  • a recent serious injury
  • a recent surgical procedure (including dental surgery – consult a dentist about this)
  • a condition (disease) affecting the patient’s blood clotting
  • recent bleeding from the stomach or intestines (such as stomach ulcer or intestinal polyps).
• The patient will undergo any surgical procedures (including dental procedures) during treatment with Ticagrelor Teva. This is due to an increased risk of bleeding. The doctor may advise stopping the medicine 5 days before the planned procedure.
• The patient has a slow heart rate (usually less than 60 beats per minute) and does not have a pacemaker implanted.
• The patient has asthma or other lung diseases or breathing difficulties.
• The patient develops breathing problems such as rapid breathing, slow breathing, or apnoea. The doctor will decide if further evaluation is needed.
• The patient has any liver disorders or has previously had a condition that may have damaged the liver.
• Blood tests have shown elevated levels of uric acid in the patient.

Talk to your doctor or pharmacist before taking this medicine if any of the above situations apply (or if you are unsure).
If the patient is taking both Ticagrelor Teva 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 Teva and heparin, as Ticagrelor Teva may affect the test result.

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

Ticagrelor Teva with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This is necessary because Ticagrelor Teva may affect the action of other medicines, and other medicines may affect Ticagrelor Teva.

Inform your 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 your 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), 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 ketoconazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanawir (used to treat HIV and AIDS infections), cimetidine (used to treat heartburn), ergot alkaloids (used to treat migraines and headaches).

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

Pregnancy and breastfeeding
Ticagrelor Teva is not recommended during pregnancy or if there is a possibility of becoming pregnant. Women of childbearing potential should use appropriate contraceptive methods while taking this medicine to avoid pregnancy.

If the patient is breastfeeding, inform the doctor before taking this medicine. The doctor will discuss the benefits and risks of using Ticagrelor Teva during breastfeeding.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Driving and using machines
It is unlikely that Ticagrelor Teva impairs the ability to drive or operate machinery. However, if dizziness or confusion occurs during treatment, caution should be exercised when driving or operating machinery.

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

3. How to take Ticagrelor Teva

This medicine should always be taken exactly as your doctor or pharmacist has told you.
If you are unsure, ask your doctor or pharmacist.

Ticagrelor Teva 90 mg tablets

• The initial dose is two tablets taken together (a loading dose of 180 mg). This dose is usually given to patients in hospital.
• After the initial dose, the usual dose is 90 mg twice daily for up to 12 months, unless your doctor tells you otherwise.
• It is recommended that you take the medicine at the same time each day (for example, one tablet in the morning and one in the evening).

Taking Ticagrelor Teva with other medicines that prevent blood clotting
Your doctor will usually recommend that you also take acetylsalicylic acid. This is a substance found in many medicines that help prevent blood clotting. Your doctor will tell you what dose to take (usually between 75 and 150 mg per day).

How to take Ticagrelor Teva

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

What to do if you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, you may crush it and mix it 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 make sure you take the full dose, add another half glass of water to the same container, swirl gently, and drink.
• If you are being treated in hospital, the crushed tablet mixed with water may be given through a nasogastric tube.

Taking more Ticagrelor Teva than you should
If you take more Ticagrelor Teva than you should, contact your doctor immediately or go to the nearest hospital. Take the medicine pack with you. There may be an increased risk of bleeding.

If you forget to take Ticagrelor Teva

• If you forget to take 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 Teva
Do not stop taking Ticagrelor Teva without talking to your doctor. You should take the medicine regularly and for as long as your doctor tells you to. Stopping Ticagrelor Teva may increase your risk of having another heart attack or stroke, or of dying from a heart- or blood vessel-related condition.

If you have any further questions about how to use this medicine, ask 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:
Ticagrelor Teva affects blood clotting, therefore most adverse reactions 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 uncommonly, but may be life-threatening.
Contact a doctor immediately if any of the following symptoms occur – urgent medical attention may be required:

• Bleeding into the brain or intracranial 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 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
  • urine that is pink, red or brown in colour
  • vomiting blood or vomit that looks like coffee grounds
  • stools that are red or black (resembling tar)
  • coughing up or vomiting blood clots
• Fainting
  • temporary loss of consciousness caused by a sudden reduction in blood flow to the brain (this 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 fatigue or disorientation.

Discuss with a doctor if the patient experiences:

• shortness of breath (dyspnoea) – this occurs very commonly. It may be caused by heart disease or another condition, or may be an adverse reaction to Ticagrelor Teva. Dyspnoea associated with Ticagrelor Teva is usually mild in severity and is characterised by sudden, unexpected breathlessness, usually 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 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 caused by 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
• Feeling dizzy, lightheaded 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 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
• Visual disturbances caused by blood in the eye
• Bleeding from the reproductive tract 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, tell a doctor, pharmacist or nurse. Adverse reactions can also 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
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
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 Ticagrelor Teva

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and
blister after 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 packaging and other information

What Ticagrelor Teva contains
The active substance is ticagrelor.
Each film-coated tablet contains 90 mg of ticagrelor.
The other ingredients are:
Tablet core: mannitol (E421), calcium hydrogen phosphate, povidone, sodium starch glycolate type A,
magnesium stearate (E470b)
Tablet coating: hypromellose (E464), titanium dioxide (E171), talc (E553b), macrogol (E1521),
yellow iron oxide (E172) and red iron oxide (E172)

What Ticagrelor Teva looks like and contents of the pack
Round, light yellow to yellow film-coated tablets marked with "A91" on one side and unmarked on the other side, with a diameter of approximately 9 mm.
The following pack sizes are available:
Calendar blister made of OPA/Al/PVC-Al and PVC/PVDC-Al foil with sun/moon symbols
Pack size: 56 tablets.
Perforated calendar blister with single doses made of OPA/Al/PVC-Al and PVC/PVDC-Al foil with sun/moon symbols
Pack size: 56x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Manufacturers
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovića 25, Zagreb, 10000
Croatia
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovića 25, Zagreb, 10000
Croatia
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, Kraków
31-546 Poland

For more detailed information, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.,
ul. Emilii Plater 53
00-113 Warsaw
tel. (22) 345 93 00

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

| Member State | Name of the medicinal product | |------------------|-----------------------------------| | Bulgaria | Тикагрелор Тева 90 mg филмирани таблетки
Ticagrelor Teva 90 mg film-coated tablets | | Germany | Ticagrelor Teva 90 mg Filmtabletten | | Poland | Ticagrelor Teva |