Ticagrelor Viatris 60 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ticagrelor Viatris 60mg Film-coated Tablets EFG

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet

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

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

Ticagrelor Viatris is a medicine that contains the active substance ticagrelor. It is used to prevent atherothrombotic events (problems caused by blood clots in arteries) in adults with:

• Acute coronary syndrome (ACS), a condition where blood flow to the heart is suddenly reduced or blocked, such as in heart attack or unstable angina;
• A history of myocardial infarction (heart attack); or
• Severe peripheral artery disease.

Ticagrelor Viatris is used in combination with acetylsalicylic acid (aspirin) to prevent blood clots from forming in blood vessels. This helps reduce the risk of heart attack, stroke, or death due to cardiovascular causes.

What is Ticagrelor Viatris

This medicine contains an active substance called ticagrelor. It belongs to a group of medicines known as antiplatelet agents.

What Ticagrelor Viatris is used for

This medicine, in combination with acetylsalicylic acid (another antiplatelet agent), is intended for use in adults only. You have been prescribed this medicine because you have had:

• a myocardial infarction more than one year ago.

This medicine reduces the risk of further myocardial infarction, stroke, or death due to heart or blood vessel disease.

How ticagrelor viatris works

This medicine acts on blood cells called 'platelets' (also known as thrombocytes). These very small blood cells help stop bleeding by clumping together to plug small holes in damaged or injured blood vessels.

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

• the clot may completely block blood flow; this can cause a heart attack (myocardial infarction) or a stroke, or
• the clot may partially block blood vessels leading to the heart; this reduces blood flow to the heart and may cause intermittent chest pain (known as 'unstable angina').

This medicine helps prevent platelet aggregation. This reduces the likelihood of a blood clot forming, which could otherwise reduce blood flow.

2. What you need to know before starting Ticagrelor Viatris

Do not take Ticagrelor Viatris if:

• You are allergic to ticagrelor or to any of the other ingredients of this medicine (listed in section 6).
• You are currently experiencing bleeding.
• 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 infection and AIDS)

Do not take this medicine if any of the above apply to you. 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 an increased risk of bleeding due to:
  • a recent severe injury
  • a recent surgical procedure (including dental procedures; ask your dentist about this)
  • a disorder affecting blood clotting
  • recent stomach or intestinal bleeding (such as stomach ulcer or colon 'polyps')
• You are scheduled to undergo any surgical procedure (including dental procedures) while taking this medicine. This is because the risk of bleeding may increase. Your doctor may decide to stop treatment with this medicine 5 days before surgery.
• Your heart rate is abnormally slow (normally less than 60 beats per minute) and you do not already have a device implanted to regulate your heart rhythm (pacemaker).
• You have asthma or other lung problems or difficulty breathing.
• You develop irregular breathing patterns, such as periods of rapid breathing, slow breathing, or brief pauses in breathing. Your doctor will decide whether you need further evaluation.
• You have had liver problems or previously had a condition that may have affected your liver.
• You have had a blood test showing elevated levels of uric acid.

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

If you are taking ticagrelor and heparin:

? Your doctor may require a blood sample for diagnostic testing if they suspect the presence of a rare platelet disorder caused by heparin. It is important to inform your doctor that you are taking ticagrelor and heparin, as this medication may affect the diagnostic test.

Children and adolescents

This medicinal product is not recommended for use in children and adolescents under 18 years of age.

Use of Ticagrelor Viatris with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because this medicine may affect the way some medicines work, and some medicines may affect ticagrelor.

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

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

In particular, inform 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), commonly 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 acid), and ergot alkaloids (used to treat migraines and headaches).

Also inform your doctor that because you are taking this medicine, you may have an increased risk of bleeding if your doctor administers fibrinolytics, often called 'clot dissolvers', such as streptokinase or alteplase.

Pregnancy and breastfeeding

The use of 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 machinery. However, if you feel dizzy or confused while taking this medicine, take caution when driving or operating machinery.

This medicine contains sodium

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 for use of this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to take

• The usual dose is one 60 mg tablet twice daily. Continue taking this medicine until your doctor tells you otherwise.
• Take this medicine at the same time each day (for example, one tablet in the morning and one at night).

Ticagrelor Viatris with other blood-thinning medicines

Your doctor will usually also prescribe acetylsalicylic acid. This is a substance present 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 may take the tablet with or without food.
• You can check when you last took this medicine by looking at the blister pack. A sun (for morning) and a moon (for night) are shown. This will indicate whether you have taken your dose.

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.
• Stir and drink immediately.
• To ensure no medicine is left behind, rinse the empty glass with another half glass of water and drink it.

If you are in hospital, this tablet may be administered mixed with a small amount of water through a tube inserted through the nose (nasogastric tube).

If you take more Ticagrelor Viatris than you should

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

If you forget to take Ticagrelor Viatris

• If you forget to take a dose, simply take your next dose at the usual time.
• Do not take a double dose (two doses at the same time) to make up for missed 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 to. If you stop taking this medicine, your risk of having another heart attack or stroke, or of dying from a heart or blood vessel-related disease, may increase.

If you have any further questions about 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 everyone will experience them.

The following side effects may occur with this medicine:

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

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

• Bleeding in the brain or within the skull is an uncommon side effect, and may cause signs of stroke such as:

  • sudden numbness or weakness in the arms, legs, or face, especially if affecting only one side of the body
  • sudden confusion, difficulty speaking or understanding others
  • sudden difficulty walking or loss of balance or coordination
  • sudden severe dizziness or sudden severe headache of unknown cause

• Signs of bleeding such as:

  • severe or uncontrollable bleeding
  • unexpected bleeding or bleeding that lasts a long time
  • pink, red, or brown urine
  • vomiting blood or vomit that looks like "coffee grounds"
  • black or red stools (resembling tar)
  • coughing up blood 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 disorder 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), unexplained extreme tiredness or confusion

Consult your doctor if you notice any of the following:

• Shortness of breath – this is very common. It may be due to your heart condition or another cause, or it may be a side effect of this medicine. Shortness of breath related to ticagrelor is usually mild and typically characterized by a sudden, unexpected need for air, occurring usually at rest. It may appear in the first weeks of treatment and in many cases may resolve over time. If you think your shortness of breath has worsened or persists, inform 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)

• High level 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
• Dizziness or sensation of spinning
• Diarrhea or indigestion
• Feeling unwell (nausea)
• Constipation
• Rash
• Itching
• Severe joint pain and swelling – these are signs of gout
• Dizziness, lightheadedness, or blurred vision – these are signs of low blood pressure
• Nosebleeds
• Heavier bleeding than usual after surgery or cuts (e.g., while shaving) and wounds
• Bleeding from the stomach lining (ulcer)
• Bleeding gums

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
• Heavier vaginal bleeding, or bleeding occurring at different times than your usual menstrual period
• Bleeding into 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 available data)

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human 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 sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and outer packaging following EXP/EXP. The expiry date refers to the last day of the month indicated.

This medicine requires no special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return empty containers and any unused medicines to the SIGRE collection point at your pharmacy. If you are unsure how to dispose of your containers and unused medicines, ask your pharmacist. This 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 components are:

Tablet core: mannitol (E421), calcium hydrogen phosphate dihydrate, corn starch, pregelatinized starch (corn), talc (E553b), sodium stearyl fumarate.

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

Appearance of the product and contents of the container

Film-coated tablet (tablet).

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

This medicine is available in:

• Calendar blister packs (with sun/moon symbols) in packs of 14, 56 and 168 tablets
• Standard blisters (with sun/moon symbols) in packs of 60 tablets
• Multipack containing 168 tablets (3 packs of 56) in calendar blister packs (with sun/moon symbols)
• Multipack containing 180 tablets (3 packs of 60) in standard blisters (with sun/moon symbols)
• Perforated unit dose blister packs in packs of 14, 56 and 60 single-dose tablets
• Multipack containing 168 tablets (3 packs of 56) in perforated unit dose blister packs
• Bottles containing 30, 60 and 250 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

PharOS MT Ltd
HF 62X
Hal Far Industrial Estate
Birzebbugia, BBG3000
Malta

For more information about this medicine, contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicine is authorised in the European Economic Area (EEA) member states under the following names:

Germany Ticagrelor Viatris 60 mg Filmtabletten
Austria Ticagrelor Viatris 60 mg Filmtabletten
Belgium Ticagrelor Viatris 60 mg filmomhulde tabletten
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 kalvopäällysteinen tabletti
Greece Ticagrelor/Mylan F.C.TAB 60 mg/TAB
Ireland Ticagrelor Viatris 60 mg film-coated tablets
Iceland Ticagrelor Viatris 60 mg filmuhúðaðar töflur
Italy Ticagrelor Mylan
Luxembourg Ticagrelor Viatris 60 mg comprimés pelliculés
Norway Ticagrelor Viatris 60 mg film-coated tablets
Netherlands Ticagrelor Viatris 60 mg, filmomhulde tabletten
Portugal Ticagrelor Mylan
United Kingdom (Northern Ireland) Ticagrelor 60 mg film-coated tablets
Czech Republic Ticagrelor Viatris
Sweden Ticagrelor Viatris

Date of the most recent review of this leaflet: September 2024.

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