TICAGRELOR VIATRIS 60 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ticagrelor Viatris 60mg film-coated tablets EFG

Read all of this leaflet carefully before you start 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, 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

What is Ticagrelor Viatris

This medicine contains the active substance ticagrelor. It belongs to a group of medicines called platelet aggregation inhibitors.

What Ticagrelor Viatris is used for

This medicine, in combination with acetylsalicylic acid (another platelet aggregation inhibitor), is to be used only in adults. You have been prescribed this medicine because you have had:

• a heart attack, more than a year ago.

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

How ticagrelor viatris works

This medicine works on cells called ‘platelets’ (also called thrombocytes). These very small blood cells help stop bleeding by clumping together to block small holes in blood vessels that are cut or damaged.

However, platelets can also form clots inside damaged blood vessels in the heart and brain. This can be very dangerous because:

• the clot can completely block the blood flow; this can cause a heart attack (myocardial infarction) or a stroke, or
• the clot can partially block the blood vessels that go to the heart; this reduces blood flow to the heart and can cause intermittent chest pain (called ‘unstable angina’).

This medicine helps prevent platelets from clumping together. This reduces the chance of a blood clot forming that could reduce blood flow.

2. What you need to know before you take Ticagrelor Viatris

Do not take Ticagrelor Viatris if:

• You are allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6).
• You have a current bleeding disorder.
• You have had a stroke caused by bleeding in the brain.
• You have severe liver disease.
• You are 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)

Do not take this medicine if you are in any of the above situations. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine if:

• You have a higher risk of bleeding due to:
• • a recent severe injury
  • recent surgery (including dental surgery, ask your dentist about this)
  • you have a disorder that affects blood clotting
  • recent stomach or intestine bleeding (such as stomach ulcers or colon polyps)
• You need to have surgery (including dental surgery) at any time while taking this medicine. This is because it increases the risk of bleeding. Your doctor may want to stop your treatment with this medicine 5 days before surgery.
• Your heart rate is abnormally slow (usually less than 60 beats per minute) and you do not have a device that regulates your heart (pacemaker).
• You have asthma or other lung problems or breathing difficulties.
• You develop irregular breathing patterns, such as rapid, slow, or brief pauses in breathing. Your doctor will decide if you need any further evaluation.
• You have had any liver problems or have had a disease that may have affected your liver.
• You have had a blood test that shows high levels of uric acid.

If any of the above applies to you (or if you are unsure), consult your doctor or pharmacist before taking this medicine.

If you are taking ticagrelor and heparin:

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Children and adolescents

This medicine is not recommended for children and adolescents under 18 years of age.

Using Ticagrelor Viatris with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This is because this medicine may affect how some medicines work and some medicines may affect ticagrelor.

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

• Rosuvastatin (a medicine to treat high cholesterol)
• more than 40 mg daily of simvastatin or lovastatin (medicines used to treat high cholesterol)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine, and phenobarbital (used to control epilepsy)
• digoxin (used to treat heart failure)
• cyclosporin (used to suppress the body's immune system)
• quinidine and diltiazem (used to treat irregular heart rhythms)
• beta-blockers and verapamil (used to treat high blood pressure)
• morphine and other opioids (used to treat acute pain)

In particular, tell your doctor or pharmacist if you are taking any of the following medicines that increase the risk of bleeding:

• ‘oral anticoagulants’, often referred to as ‘blood thinners’, including warfarin.
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) frequently taken as painkillers, such as ibuprofen and naproxen.
• Selective Serotonin Reuptake Inhibitors (SSRIs) taken 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 stomach acidity), and ergot alkaloids (used to treat migraines and headaches).

Tell your doctor because, due to taking this medicine, you may have a higher risk of bleeding if your doctor gives you fibrinolytics, often referred to as ‘clot dissolvers’, such as streptokinase or alteplase.

Pregnancy and breastfeeding

This medicine is not recommended if you are pregnant or may become pregnant. Women should use appropriate contraceptive methods to prevent pregnancy while taking this medicine.

Consult your doctor before taking this medicine if you are breastfeeding. Your doctor will explain the benefits and risks of taking this medicine during this period.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

This medicine is unlikely to affect your ability to drive or use machines. If you feel dizzy or confused while taking this medicine, be careful while driving or using machines.

This medicine containssodium

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

3. How to take Ticagrelor Viatris

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much to take

• The normal dose is one 60 mg tablet twice a day. Keep taking this medicine for as long as your doctor tells you.
• Take this medicine at the same time every day (e.g., one tablet in the morning and one in the evening).

Ticagrelor Viatris with other medicines for blood clotting

Your doctor will also usually prescribe acetylsalicylic acid. This is a substance found in many medicines used to prevent blood clotting. Your doctor will tell you how much to take (usually between 75-150 mg daily).

How to take Ticagrelor Viatris

• You can take the tablet with or without food.
• You can check when you took your last tablet of this medicine by looking at the blister pack. A sun symbol (for morning) and a moon symbol (for evening) will appear. This will tell you if you have taken your dose.

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.
• Stir and drink immediately.
• To make sure there is no medicine left, rinse the empty glass with another half a glass of water and drink it.

If you are in the hospital, this tablet may be given to you mixed with a little water through a tube in your nose (nasogastric tube).

If you take more Ticagrelor Viatris than you should

If you take more ticagrelor than you should, consult your doctor or go to the hospital immediately. Take the medicine pack with you. You may have a higher risk of bleeding.

If you forget to take Ticagrelor Viatris

• If you forget to take a dose, just take your next dose at the usual time.
• Do not take a double dose (two doses at the same time) to make up for forgotten doses.

If you stop taking Ticagrelor Viatris

Do not stop taking this medicine without consulting your doctor. Take this medicine regularly and for as long as your doctor tells you. If you stop taking this medicine, you may increase the risk of having another heart attack or stroke, or dying from a heart or blood vessel-related 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, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur with this medicine:

• Ticagrelor affects blood clotting, so most side effects are related to bleeding.
• Bleeding can occur anywhere in the body. Some level of bleeding is common (such as bruising and nosebleeds).
• Severe bleeding is rare but can be life-threatening.

Tell your doctor immediately if you notice any of the following - you may need urgent medical treatment:

• A bleed in the brain or inside the skull is an uncommon side effect, and can cause signs of a stroke such as:
• • sudden numbness or weakness of the arms, legs, or face, especially if it affects only one side of the body
  • sudden confusion, difficulty speaking or understanding others
  • sudden difficulty walking or loss of balance or coordination
  • sudden feeling of dizziness or severe headache of unknown cause

• Signs of bleeding such as:
• • severe or uncontrolled bleeding
  • unexpected or prolonged bleeding
  • urine that is pink, red, or brown
  • vomiting blood or vomit that looks like “coffee grounds”
  • black or red stools (like tar)
  • coughing or vomiting blood

• Fainting (syncope)
• • temporary loss of consciousness due to a sudden drop in blood flow to the brain (common)

• Signs of a blood clotting problem called Thrombotic Thrombocytopenic Purpura (TTP) such as:
• • fever and purple spots (called purpura) on the skin and in the mouth, with or without yellowing of the skin or eyes (jaundice), extreme tiredness, or confusion

Tell your doctor if you notice any of the following:

• Difficulty breathing- this is very common.It may be due to your heart disease or another cause, or it may be a side effect of this medicine. Difficulty breathing related to ticagrelor is usually mild and is characterized by a sudden, unexpected need for air that usually occurs at rest and may disappear in many cases. If you think your difficulty breathing has worsened or lasts a long time, tell your doctor. They will decide if you need treatment or further investigations.

Other possible side effects

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

• High levels of uric acid in the blood (as seen in blood tests)
• Bleeding caused by blood disorders

Common (may affect up to 1 in 10 people)

• Bruising
• Headache
• Feeling dizzy or like everything is spinning
• Diarrhea or indigestion
• Feeling sick (nausea)
• Constipation
• Rash
• Itching
• Severe pain and inflammation in the joints – these are signs of gout
• Feeling dizzy or lightheaded, or blurred vision – these are signs of low blood pressure
• Nosebleeds
• Bleeding more than usual after surgery or cuts (e.g., when shaving) and injuries
• Stomach bleeding (ulcer)
• Gum bleeding

Uncommon (may affect up to 1 in 100 people)

• Allergic reaction – a skin rash, itching, or swelling of the face or swelling of the lips/tongue may be signs of an allergic reaction
• Confusion
• Vision problems caused by bleeding in the eye
• Vaginal bleeding that is heavier than usual, or that occurs at different times, than your usual menstrual period
• Bleeding in the joints and muscles that causes painful inflammation
• Blood in the ear
• Internal bleeding, this can cause dizziness or lightheadedness

Frequency not known (cannot be estimated from the available data)

• Abnormally slow heart rate (usually below 60 beats per minute)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ticagrelor Viatris

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 blister and the carton after EXP/CAD. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

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 protect the environment.

6. Contents of the pack and other information

Composition of ticagrelor viatris

• The active substance is ticagrelor.

Each film-coated tablet contains 60 mg of ticagrelor.

• The other ingredients are:

Core of the tablet

Coating of the tablets: poly (vinyl alcohol) (E1203), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate, lauryl sulfate, red iron oxide (E172), black iron oxide (E172).

Appearance of the product and packaging content

Film-coated tablet (tablet).

The tablets are round, biconvex, pink in color, marked with a '60' on one side and smooth on the other, with a diameter of 8.6 mm ± 5%.

This medication is available in:

• calendar blister pack (with sun/moon symbols) in packs of 14, 56, and 168 tablets
• standard blisters (with sun/moon symbols) in packs of 60 tablets
• multipack with 168 (3 packs of 56) tablets in calendar blister pack (with sun/moon symbols)
• multipack with 180 (3 packs of 60) tablets in standard blisters (with sun/moon symbols)
• perforated unit dose blister pack in packs of 14, 56, and 60 single-dose tablets
• multipack with 168 (3 packs of 56) single-dose tablets in perforated unit dose blister pack
• bottles of 30, 60, and 250 tablets

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

PharOS MT Ltd,

HF 62X,

Hal Far Industrial Estate,

Birzebbugia, BBG3000,

Malta

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany Ticagrelor Viatris 60 mg Filmtabletten

Austria Ticagrelor Viatris 60 mg Filmtabletten

Belgium Ticagrelor Viatris 60 mg film-coated tablets

Cyprus Ticagrelor Mylan 60 mg film-coated tablets

Denmark Ticagrelor Viatris

Spain Ticagrelor Viatris 60 mg film-coated tablets EFG

Estonia Ticagrelor Viatris

Finland Ticagrelor Viatris 60 mg film-coated tablet

Greece Ticagrelor/Mylan F.C.TAB 60 mg/TAB

Ireland Ticagrelor Viatris 60 mg film-coated tablets

Iceland Ticagrelor Viatris 60 mg film-coated tablets

Italy Ticagrelor Mylan

Luxembourg Ticagrelor Viatris 60 mg film-coated tablets

Norway Ticagrelor Viatris 60 mg film-coated tablets

Netherlands Ticagrelor Viatris 60 mg, film-coated tablets

Portugal Ticagrelor Mylan

United Kingdom (Northern Ireland) Ticagrelor 60 mg film-coated tablets

Czech Republic Ticagrelor Viatris

Sweden Ticagrelor Viatris

Date of the last revision of this leaflet:September 2024.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/