Ticagrelor Viatris 90 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ticagrelor Viatris 90mg 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 must not be given to other people, even if they have the same symptoms as you, since 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 contents

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 used to prevent complications caused by blood clots, such as heart attack or stroke. It belongs to a group of medicines called antiplatelet agents. These medicines help prevent blood clots by stopping platelets (a type of blood cell) from sticking together.

Ticagrelor Viatris is used in adults who have had a heart attack or who have unstable angina (chest pain due to poor blood flow to the heart) requiring hospitalization. It is used together with acetylsalicylic acid (another antiplatelet medicine) to prevent blood clots from forming in blood vessels, reducing the risk of further heart attacks, stroke, or death.

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. Your doctor has prescribed this medicine because you have had:

• a myocardial infarction or
• unstable angina (angina or chest pain that is not well controlled).

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

How ticagrelor viatris works

This medicine acts on blood cells called 'platelets' (also known as thrombocytes). These tiny 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 (called '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 a surgical procedure (including dental procedures) at any time 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 rapid breathing, slowed breathing, or brief pauses in breathing. Your doctor will decide whether you need further evaluation.
• You have had liver problems or a previous illness that may have affected your liver.
• You have had a blood test showing an increased level 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 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

Tell 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.

Tell 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 defenses)
• 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, 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), 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 reflux), 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 fibrinolytic agents, often referred to as '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 use of machines

This medicine is unlikely to affect your ability to drive or use machinery. 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 administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to take

• The initial dose is two tablets taken at the same time (a loading dose of 180 mg). This dose is usually administered in hospital.
• After this initial dose, the usual dose is one 90 mg tablet twice daily for 12 months, unless 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 an ingredient 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 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 help you remember 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 that as well.

If you are in hospital, this tablet may be given to you 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, consult 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 forgotten doses.

If you stop taking Ticagrelor Viatris

Do not stop taking this medicine without consulting your doctor. Take this medicine regularly for as long as your doctor prescribes it. 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 how to use 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.

Contact 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 a stroke such as:

  • sudden numbness or weakness in 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 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 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 or in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained extreme tiredness or confusion

Contact 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 is typically characterized by a sudden, unexpected need for air that usually occurs at rest. It may appear during the first weeks of treatment and may resolve in many cases. If you feel 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 due to 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 normal 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 may also report side effects 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 the 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. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure how to dispose of unused medicines or their packaging, ask your pharmacist. This helps 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 90 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, yellow iron oxide (E172).

Appearance of the product and contents of the pack

Film-coated tablet (tablet).

The tablets are round, biconvex, yellow in colour, marked with '90' on one side and plain on the other, with a diameter of 9.6 mm ± 5%.

This medicine is available in:

• Calendar blister packs (with sun/moon symbols) in packs of 14, 56, and 168 tablets
• Standard blister packs (with sun/moon symbols) in packs of 60 tablets
• Multipacks containing 168 tablets (3 packs of 56) in calendar blister packs (with sun/moon symbols)
• Multipacks containing 180 tablets (3 packs of 60) in standard blister packs (with sun/moon symbols)
• Perforated unit-dose blister packs in packs of 14, 56, 60, and 100 single-dose tablets
• Multipacks containing 168 single-dose tablets (3 packs of 56) in perforated unit-dose blister packs
• Bottles containing 30, 60, and 250 tablets
• Tablets in standard blister packs (with sun/moon symbols)

Only certain 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 further 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 member states under the following names:

Germany Ticagrelor Viatris 90 mg Filmtabletten
Austria Ticagrelor Viatris 90 mg Filmtabletten
Belgium Ticagrelor Viatris 90 mg filmomhulde tabletten
Cyprus Ticagrelor Mylan 90 mg film-coated tablets
Denmark Ticagrelor Viatris
Spain Ticagrelor Viatris 90 mg film-coated tablets EFG
Estonia Ticagrelor Viatris
Finland Ticagrelor Viatris 90 mg kalvopäällysteinen tabletti
France Ticagrelor Viatris 90 mg, comprimés pelliculés
Greece Ticagrelor/Mylan F.C.TAB 90 mg/TAB
Ireland Ticagrelor Viatris 90 mg film-coated tablets
Iceland Ticagrelor Viatris 90 mg filmuhúðaðar töflur
Italy Ticagrelor Mylan
Latvia Ticagrelor Viatris 90 mg apvalkotas tabletes
Lithuania Ticagrelor Viatris 90 mg plevele dengtos tabletes
Luxembourg Ticagrelor Viatris 90 mg comprimés pelliculés
Norway Ticagrelor Viatris 90 mg film-coated tablets
Netherlands Ticagrelor Viatris 90 mg, filmomhulde tabletten
Portugal Ticagrelor Mylan
United Kingdom (Northern Ireland) Ticagrelor 90 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 Medical Devices (AEMPS): https://www.aemps.gob.es/