Ticagrelor teva

Package leaflet: Information for the patient

Ticagrelor Teva, 60 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. 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 side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

What Ticagrelor Teva is used for
Ticagrelor Teva, in combination with acetylsalicylic acid (another antiplatelet medicine), is used only in adults. This medicine is prescribed for patients who have had:

Ticagrelor Teva 60 mg, tablets

• a heart attack more than one year ago. 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 cuts or damage in blood vessels.

However, platelets can 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 (of the heart muscle) 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 (called unstable angina).

Ticagrelor Teva helps prevent platelets from sticking together, 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 atazanavir (used in the treatment of HIV infection and AIDS).

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 taking Ticagrelor Teva, discuss with your doctor or pharmacist if:

• The patient has an increased risk of bleeding due to:
  • recent serious injury
  • recent surgical procedure (including dental procedures – consult a dentist in this matter)
  • a condition (disease) affecting blood clotting
  • recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps).
• The patient will undergo any surgical procedure (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 disorders such as rapid breathing, slow breathing, or apnoea. The doctor will decide whether further evaluation is necessary.
• 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 have any doubts).
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 diagnostic test result.

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

Ticagrelor Teva and 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 in doses exceeding 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), 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 in the treatment of HIV infection and AIDS), 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 measures 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 plans to have a child, she should consult a doctor or pharmacist before taking this medicine.

Driving and operating machinery
It is unlikely that Ticagrelor Teva affects 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 prescribed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
What dose to take
Ticagrelor Teva 60 mg tablets

• The usual dose is one 60 mg tablet twice daily. You should continue taking Ticagrelor Teva for as long as your doctor recommends.
• It is recommended to take the medicine at the same time each day (e.g. one tablet in the morning and one in the evening).

Taking Ticagrelor Teva 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 inform you of the dose to take (usually between 75 and 150 mg daily).
How to take Ticagrelor Teva

• Tablets may 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 a sun (for morning doses) and a 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, 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 ensure the entire dose is taken, pour another half glass of water into the glass, swirl and drink. If you are being treated in hospital, the crushed tablet may be administered through a nasogastric tube after dissolving in water.

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

• 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 Teva
Do not stop taking Ticagrelor Teva without consulting your doctor. You should take the medicine regularly and for as long as your doctor recommends. Stopping Ticagrelor Teva
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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The following adverse effects may occur during treatment with this medicine:
Ticagrelor Teva 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.
You should contact your 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 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 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 discoloured pink, red or brown
  • vomiting blood or material that looks like coffee grounds
  • stools coloured 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 (this is 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.

You should discuss with your doctor if you experience:

• shortness of breath – this is very common. It may be caused by heart disease or another condition, or may be an adverse effect of Ticagrelor Teva. Shortness of breath associated with Ticagrelor Teva treatment is usually mild and is characterised by sudden, unexpected breathlessness, usually occurring at rest. It may appear during the first few weeks of treatment and then not occur again 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 necessary.

Other possible adverse effects
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
• Dizziness or spinning sensation
• Diarrhoea or indigestion
• Nausea (feeling sick)
• 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 cuts (e.g. during 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 effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse effects 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 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 Teva

Keep this medicine out of the 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 instructions apply for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Ticagrelor Teva contains
The active substance is ticagrelor.
Each film-coated tablet contains 60 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), macrogol (E1521), talc (E553b),
and iron oxide red (E172)

What Ticagrelor Teva looks like and contents of the pack
Round, light pink to pink film-coated tablets, marked with "137" on one side and "A" on the other, with a diameter of approximately 8 mm.

Available pack sizes:
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

Manufacturer
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 further 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 European Economic Area countries under the following names:

| Member country | Name of the medicinal product | |--------------------|-------------------------------------| | Bulgaria | Тикагрелор Тева 60 mg филмирани таблетки
Ticagrelor Teva 60 mg film-coated tablets | | Germany | Ticagrelor Teva 60 mg Filmtabletten | | Poland | Ticagrelor Teva |