Ticagrelor Teva

Package Leaflet: Information for the Patient

Ticagrelor Teva, 90 mg, Film-Coated Tablets

Ticagrelor

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Ticagrelor Teva and what is it used for
• 2. Important information 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 is Ticagrelor Teva

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

What is Ticagrelor Teva used for

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

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

The medicine reduces the risk of having another heart attack or stroke, or dying from a heart or blood vessel-related problem.

How Ticagrelor Teva works

Ticagrelor Teva works by affecting blood cells called platelets (also known as thrombocytes). Platelets are very small blood cells which help to stop bleeding by clumping together to form a blood clot. However, platelets can also form blood clots in diseased blood vessels in the heart and brain, which can lead to heart attacks and strokes.

• a blood clot can completely block the blood flow - this can cause a heart attack (myocardial infarction) or stroke, or
• a blood clot can partially block the blood vessels leading to the heart - this reduces blood flow to the heart and can cause chest pain (unstable angina)

Ticagrelor Teva helps to prevent platelets from clumping together and forming blood clots, reducing the risk of a blood clot forming and so reducing the risk of another heart attack or stroke.

2. Important information before taking Ticagrelor Teva

When not to take Ticagrelor Teva

• If you are allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6).
• If you are currently bleeding.
• If you have had a stroke caused by bleeding in the brain.
• If you have severe liver disease.
• If you are 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 Teva if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking Ticagrelor Teva, tell your doctor or pharmacist if:

• you have an increased risk of bleeding due to:
• a recent serious injury
• a recent surgical procedure (including dental procedures - consult your dentist)
• a condition that affects blood clotting
• recent bleeding from the stomach or gut (such as stomach ulcers or colon polyps)
• you will be having surgery (including dental procedures) at any time during treatment with Ticagrelor Teva. This is because of the increased risk of bleeding. Your doctor may advise you to stop taking Ticagrelor Teva for 5 days before the surgery.
• you have a slow heart rate (usually less than 60 beats per minute) and do not have a pacemaker.
• you have asthma or other lung disease or breathing difficulties.
• you develop breathing difficulties such as rapid or slow breathing rate or pauses in breathing. Your doctor will decide if further evaluation is needed.
• you have any liver problems or have had a liver disease in the past.
• you have high levels of uric acid in your blood (found in blood tests).

Tell your doctor or pharmacist if any of the above applies to you (or if you are unsure). If you are taking Ticagrelor Teva and heparin:

• Your doctor may take a blood sample to check for a rare blood clotting disorder caused by heparin. It is important to tell your doctor that you are taking both Ticagrelor Teva and heparin, as Ticagrelor Teva may affect the results of the test.

Children and adolescents

Ticagrelor Teva should not be used in children and adolescents under 18 years of age.

Ticagrelor Teva with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and any you plan to take, as Ticagrelor Teva may interact with other medicines and other medicines may affect Ticagrelor Teva.

• rosuvastatin (used to lower cholesterol levels)
• simvastatin or lovastatin in doses greater than 40 mg per day (used to lower cholesterol levels)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine and phenobarbital (used to control fits)
• digoxin (used to treat heart failure)
• cyclosporin (used to suppress the immune system)
• quinidine and diltiazem (used to treat irregular heartbeats)
• beta-blockers and verapamil (used to treat high blood pressure)
• morphine and other opioids (used to treat severe pain)

Particularly tell 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), 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 atazanavir (used to treat HIV and AIDS), cisapride (used to treat heartburn), and ergot alkaloids (used to treat migraine and headache)

Also tell your doctor if you are taking Ticagrelor Teva and are at increased risk of bleeding if your doctor prescribes you fibrinolytic medicines (often called clot-busting medicines), such as streptokinase or alteplase.

Pregnancy and breastfeeding

Ticagrelor Teva should not be used during pregnancy or if you are planning to become pregnant. Women of childbearing potential should use appropriate contraceptive methods to prevent pregnancy while taking this medicine. If you are breastfeeding, consult your doctor before taking this medicine. Your doctor will discuss the benefits and risks of taking Ticagrelor Teva during breastfeeding. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Sodium

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

3. How to take Ticagrelor Teva

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist. Ticagrelor Teva, 90 mg, film-coated tablets

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

Taking Ticagrelor Teva with other anti-clotting medicines

Your doctor will usually recommend that you also take acetylsalicylic acid. 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 Teva

• You can take the tablets with or without food.
• You can check when you last took a tablet of Ticagrelor Teva by looking at the blister pack. The blister pack has a sun symbol (for morning doses) and a moon symbol (for evening doses). These symbols show you when you last took a dose.

What to do if you have difficulty swallowing the tablet

If you have difficulty swallowing the tablet, you can crush it and mix it with water as follows:

• Crush the tablet into a fine powder.
• Put the powder into half a glass of water.
• Mix and drink immediately.
• To make sure that you have taken all of the medicine, refill the glass with half a glass of water, swirl and drink. If you are in hospital, the tablet can be mixed with water and given through a nasogastric tube.

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

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

What to do if you forget to take Ticagrelor Teva

• 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 Teva

Do not stop taking Ticagrelor Teva without talking to your doctor first. You should take this medicine regularly and for as long as your doctor tells you. Stopping Ticagrelor Teva may increase your risk of having another heart attack or stroke, or dying from a heart or blood vessel-related problem. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The most common side effects are related to bleeding. Bleeding can occur anywhere in the body. Some bleeding is common (e.g. bruising and nosebleeds). Serious bleeding is less common but can be life-threatening.

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

• Bleeding in the brain or inside the skull is an uncommon side effect and may cause stroke-like symptoms such as:
• sudden numbness or weakness of your arms or legs or face, especially if it happens on only one side of your body
• sudden confusion, trouble speaking or understanding
• sudden trouble walking, dizziness, loss of balance or coordination
• sudden severe headache with no known cause
• Signs of bleeding such as:
• heavy or prolonged bleeding
• unexpected bleeding or bleeding that lasts a long time
• pink or red urine
• vomiting blood or vomit that looks like coffee grounds
• red or black stools (looking like tar)
• coughing or vomiting blood clots
• Fainting
• temporary loss of consciousness caused by a sudden drop in blood flow to the brain (common)
• Signs of a condition called thrombotic thrombocytopenic purpura (TTP), such as:
• fever and purple spots on the skin or 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 (dyspnoea) - very common. This may be due to your heart condition or another cause, or it may be a side effect of Ticagrelor Teva. Dyspnoea related to Ticagrelor Teva is usually mild and characterised by sudden, unexpected shortness of breath at rest, which may occur in the first few weeks of treatment and then persists for many weeks. If your dyspnoea gets worse or persists, contact your doctor. Your doctor will decide whether you need treatment or further investigations.

Other possible side effects

Very common (may affect more than 1 in 10 people)

• Increased levels of uric acid in the blood (found in blood tests)
• Bleeding due to blood disorders

Common (may affect up to 1 in 10 people)

• Appearance of bruises
• Headache
• Feeling dizzy or lightheaded
• Diarrhoea or indigestion
• Nausea (feeling sick)
• Constipation
• Rash
• Itching
• Increased pain and swelling of the joints - these are symptoms of gout
• Feeling dizzy or lightheaded or blurred vision - these are symptoms of low blood pressure
• Nosebleeds
• Bleeding after surgery or from cuts and wounds, which is more than usual
• Bleeding from the stomach (stomach ulcers)
• Bleeding gums

Uncommon (may affect up to 1 in 100 people)

• Allergic reactions - rash, itching, swelling of the face or lips or tongue may be signs of an allergic reaction
• Confusion
• Visual disturbances due to bleeding in the eye
• Bleeding from the reproductive organs, which is more than usual or happens at an unusual time (e.g. heavy or irregular periods)
• Bleeding into the 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 the available data)

• Abnormally low heart rate (usually less than 60 beats per minute)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the website: https://smz.ezdrowie.gov.pl. By reporting side effects you can help 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 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 conditions 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. These measures will help to 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 90 mg of ticagrelor. The other ingredients are:

Core of the tablet: mannitol (E421), calcium hydrogen phosphate, povidone, sodium starch glycolate type A, magnesium stearate (E470b)

Coating of the tablet: hypromellose (E464), titanium dioxide (E 171), talc (E553b), macrogol (E1521), yellow iron oxide (E172) and red iron oxide (E 172)

What Ticagrelor Teva looks like and contents of the pack

Yellow round film-coated tablets, 9 mm in diameter, with "A91" marked on one side and no marking on the other side. Ticagrelor Teva is available in calendar blister packs with sun/moon symbols and in perforated unit dose blister packs with sun/moon symbols. The pack sizes are: 56 tablets. Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Teva B.V.

Swensweg 5

2031GA Haarlem

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 on this medicine, please contact your local representative:

Teva Pharmaceuticals Polska Sp. z o.o.,

ul. Emilii Plater 53

00-113 Warszawa

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

Date of last revision of the package leaflet: