Ticagrelor Teva

Package Leaflet: Information for the Patient

Ticagrelor Teva, 60 mg, Coated Tablets

Ticagrelor

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

• Keep this 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 those not listed in this leaflet, please 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. 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 to patients who have had:

• heart attack, more than a year ago. The medicine reduces the likelihood of having another heart attack or stroke, or dying from a heart or blood vessel disease.

How Ticagrelor Teva works

Ticagrelor Teva works by affecting blood cells called platelets (also known as thrombocytes). Platelets are very small blood cells that help stop bleeding by clumping together and blocking small openings in 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 that comes and goes (known as unstable angina).

Ticagrelor Teva helps prevent platelets from clumping together, reducing the likelihood of a blood clot forming and reducing blood flow.

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 in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

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

• If you have an increased risk of bleeding due to:
• recent serious injury
• recent surgery (including dental surgery - consult your dentist)
• a condition that affects blood clotting
• recent bleeding from the stomach or intestines (such as stomach ulcers or intestinal polyps).
• If you will be having surgery (including dental surgery) while taking Ticagrelor Teva. This is because of the increased risk of bleeding. Your doctor may advise you to stop taking the medicine 5 days before the planned surgery.
• If you have a slow heart rate (usually less than 60 beats per minute) and do not have a pacemaker.
• If you have asthma or other lung diseases or breathing difficulties.
• If you develop breathing difficulties such as rapid breathing, slow breathing, or pauses in breathing. Your doctor will decide if further evaluation is needed.
• If you have any liver problems or have had a disease that may have damaged your liver.
• If your blood test shows high levels of uric acid.

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

• Your doctor may take a blood sample for diagnostic tests if they suspect a rare platelet disorder caused by heparin. It is essential to inform your doctor that you are taking both Ticagrelor Teva and heparin, as Ticagrelor Teva may affect the test result.

Children and adolescents

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

Ticagrelor Teva with other medicines

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

• rosuvastatin (a medicine used to lower cholesterol levels)
• simvastatin or lovastatin in doses greater than 40 mg per day (medicines used to lower cholesterol levels)
• 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 tell 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 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 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 if you are taking Ticagrelor Teva and have an increased risk of bleeding if your doctor prescribes fibrinolytic medicines, often called clot-dissolving 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. While taking the medicine, women should use appropriate contraceptive methods to avoid becoming pregnant.

If you are breastfeeding, inform your doctor before taking this medicine. Your doctor will discuss the benefits and risks of taking Ticagrelor Teva while breastfeeding.

If you are pregnant, breastfeeding, think you may be pregnant, or plan 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 disorientation while taking the medicine, be cautious when driving or using machines.

Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it 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.

How much to take

Ticagrelor Teva, 60 mg, tablets

• The usual dose is one 60 mg tablet twice a day. Continue taking Ticagrelor Teva for as long as your doctor recommends.
• It is recommended to take the medicine at the same time every 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 as well. This is a substance found in many medicines that prevent blood clotting. Your doctor will inform you about the dose to take (usually between 75 and 150 mg per day).

How to take Ticagrelor Teva

• Tablets can be taken with or without food.
• You can check when you last took a tablet 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 when you took your last 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.
• Pour the powder into half a glass of water.
• Mix and drink immediately.
• To ensure you take all the medicine, refill the glass with half a glass of water, swirl, and drink. If you are in the 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 the 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 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 having another heart attack or stroke, or dying from a heart or blood vessel disease.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ticagrelor Teva can cause side effects, although not everybody gets them. The following side effects may occur while taking this medicine:

Ticagrelor Teva affects blood clotting, so most side effects are related to bleeding. Bleeding can occur anywhere in 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 with no known cause
• Signs of bleeding, such as:
• heavy or prolonged bleeding
• unexpected or prolonged bleeding
• urine that is pink, red, or brown
• vomiting blood or coffee ground-like material
• stools that are black or tarry
• coughing or vomiting blood clots
• Fainting
• temporary loss of consciousness due to a sudden decrease in blood flow to the brain (occurs frequently)
• Signs of 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 (dyspnea) - occurs very frequently. It may be caused by heart disease or another cause, or it may be a side effect of Ticagrelor Teva. Dyspnea associated with Ticagrelor Teva 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 dyspnea worsens or persists, contact your doctor. Your 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 (vomiting)
• Constipation
• Rash
• Itching
• Increased pain and swelling of the joints - these are symptoms of gout
• Dizziness or lightheadedness or blurred vision - these are symptoms of low blood pressure
• Nosebleeds
• Bleeding after surgery or from cuts and wounds that is more than usual
• Bleeding from the stomach lining (stomach ulcers)
• 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
• Vision disturbances due to blood in the eye
• Bleeding from the reproductive tract, which is more than usual 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 those not listed in this leaflet, please inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides:

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 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.

No special storage instructions are needed.

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 pack and other information

What Ticagrelor Teva contains

The active substance is ticagrelor.

Each coated tablet contains 60 mg of ticagrelor.

The other ingredients are:

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

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

What Ticagrelor Teva looks like and contents of the pack

Round tablets, pink to pale pink in color, with the mark "137" on one side and "A" on the other, approximately 8 mm in diameter.

The following pack sizes are available:

Calendar blister pack with OPA/Al/PVC-Al and PVC/PVDC-Al foil with sun/moon symbols

Pack sizes: 56 tablets.

Perforated calendar blister pack with single doses with OPA/Al/PVC-Al and PVC/PVDC-Al foil with sun/moon symbols

Pack sizes: 56x1 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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