Ticagrelor Vivanta 90 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ticagrelor Vivanta 60 mg film-coated tablets EFG

Ticagrelor Vivanta 90 mg film-coated tablets EFG

Read the entire 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 questions, ask 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 these are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Ticagrelor Vivanta is and what it is used for
2. What you need to know before taking Ticagrelor Vivanta
3. How to take Ticagrelor Vivanta
4. Possible side effects

5 Storage of Ticagrelor Vivanta

1. Contents of the pack and other information

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

What Ticagrelor Vivanta is

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

What Ticagrelor Vivanta is used for

Ticagrelor Vivanta 60 mg film-coated tablets EFG

Ticagrelor, 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 having another myocardial infarction, a stroke, or dying from a disease related to the heart or blood vessels.

Ticagrelor Vivanta 90 mg film-coated tablets EFG

Ticagrelor, 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, or
• unstable angina (chest pain or chest discomfort that is not adequately controlled).

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

How Ticagrelor Vivanta works

Ticagrelor acts on cells called 'platelets' (also known as thrombocytes). These very small blood cells help stop bleeding by clumping together to seal 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').

Ticagrelor helps prevent platelets from clumping together. This reduces the likelihood of blood clots forming, which could otherwise reduce blood flow.

2. What you need to know before taking Ticagrelor Vivanta

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

Warnings and precautions

Talk to your doctor or pharmacist before taking ticagrelor if:

• You have a higher risk of bleeding due to:

• a recent serious injury

• a recent surgical procedure (including dental procedures; ask your dentist about this)

• a disorder affecting blood clotting

• recent bleeding from the stomach or intestines (such as stomach ulcer or colon 'polyps')

• You need to undergo surgery (including dental procedures) at any time while taking ticagrelor. This is because the risk of bleeding increases. 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 (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 further evaluation is needed.

• You have had liver problems or previously had a disease 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 he or she suspects a rare platelet disorder caused by heparin. It is important that you inform your doctor that you are taking both ticagrelor and heparin, as ticagrelor may affect the diagnostic test.

Children and adolescents

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

Other medicines and Ticagrelor Vivanta

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. This is because ticagrelor 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 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)
• cyclosporine (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 called '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 infection and AIDS), cisapride (used to treat stomach acid reflux), and ergot-derived alkaloids (used to treat migraines and headaches).

Also inform your doctor that, because you are taking ticagrelor, you may have an increased risk of bleeding if your doctor administers fibrinolytic agents, often called 'clot busters', such as streptokinase or alteplase.

Pregnancy and breastfeeding

The use of ticagrelor is not recommended if you are pregnant or could 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 ticagrelor 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 taking this medicine.

Driving and using machines

It is unlikely that ticagrelor will affect your ability to drive or use machines. However, if you feel dizzy or confused while taking this medicine, take care when driving or using machines.

3. How to take Ticagrelor Vivanta

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

How much to take

Ticagrelor Vivanta 60 mg film-coated tablets EFG

• The usual dose is one 60 mg tablet twice daily. Continue taking ticagrelor 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 Vivanta 90 mg film-coated tablets EFG

• The initial dose is two tablets taken together (a loading dose of 180 mg). This dose is normally administered in hospital.
• After this initial dose, the usual dose is one 90 mg tablet twice daily for 12 months, unless your doctor advises otherwise.
• Take this medicine at the same time each day (for example, one tablet in the morning and one at night).

Taking Ticagrelor Vivanta with other blood-thinning medicines

Your doctor will usually also 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 (normally between 75–150 mg daily).

How to take Ticagrelor Vivanta

• You may take this medicine with or without food.
• You can check when you last took a ticagrelor tablet by looking at the blister pack. A sun (for morning) and a moon (for night) are shown, which 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 it.

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

If you take more Ticagrelor Vivanta 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.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Ticagrelor Vivanta

• 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 once) to make up for a missed dose.

If you stop taking Ticagrelor Vivanta

Do not stop taking ticagrelor without consulting your doctor. Take this medicine regularly and for as long as your doctor has instructed. If you stop taking ticagrelor, 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The following adverse effects may occur with this medicine:

Ticagrelor affects blood clotting, so most adverse 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 uncommon but can be potentially fatal.

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 adverse 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, loss of balance or coordination

• sudden 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 fatigue or confusion.

Contact your doctor if you notice any of the following:

• Shortness of breath – this is very common. It may be due to heart disease or another cause, or it may be a side effect of ticagrelor. Shortness of breath related to ticagrelor is usually mild and is characterized by a sudden, unexpected need for air that typically occurs at rest and may appear during the first weeks of treatment; in many cases, it may resolve on its own. If you feel that your shortness of breath has worsened or persists, inform your doctor. Your doctor will decide whether you need treatment or further investigations.

Other possible adverse 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 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 – 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 normal 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 adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse 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 adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ticagrelor Vivanta

Keep this medicine out of the sight and reach of children.

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

• The active substance is ticagrelor.

Ticagrelor Vivanta 60 mg film-coated tablets EFG

Each film-coated tablet contains 60 mg of ticagrelor.

Ticagrelor Vivanta 90 mg film-coated tablets EFG

Each film-coated tablet contains 90 mg of ticagrelor.

• The other components are:

Tablet core: mannitol (E421), low-substituted hydroxypropyl cellulose, calcium hydrogen phosphate dihydrate, hydroxypropyl cellulose (E463) (contains silica), magnesium stearate (E470b).

Film coating of the tablets:

Ticagrelor Vivanta 60 mg film-coated tablets EFG

hypromellose 2910 (E464), titanium dioxide (E171), talc (E553b), macrogol 400 (E1521), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172)

Ticagrelor Vivanta 90 mg film-coated tablets EFG

hypromellose 2910 (E464), titanium dioxide (E171), macrogol 400 (E1521), talc (E553b), yellow iron oxide (E172).

Appearance of the product and contents of the pack

Ticagrelor Vivanta 60 mg film-coated tablets EFG

Film-coated tablets, round, biconvex, pink in colour (approximately 8 mm in diameter), engraved with “60 & M” on one side and plain on the other.

Ticagrelor Vivanta 90 mg film-coated tablets EFG

Film-coated tablets, biconvex, round, yellow in colour (approximately 9 mm in diameter), engraved with "90 & M" on one side and plain on the other.

Ticagrelor Vivanta is available in:

Ticagrelor 60 mg

• Blister packs (with sun/moon symbols) in boxes of 60 and 180 tablets
• Calendar blister packs (with sun/moon symbols) in boxes of 14, 56 and 168 tablets
• Perforated single-dose blister packs of 10 tablets; boxes of 60×1 and 180×1 tablets
• Perforated single-dose blister packs of 14 tablets; boxes of 14×1, 56×1, 168×1 tablets

Ticagrelor 90 mg

• Blister packs (with sun/moon symbols) in boxes of 60, 100 and 180 tablets
• Calendar blister packs (with sun/moon symbols) in boxes of 14, 56 and 168 tablets
• Perforated single-dose blister packs of 10 tablets; boxes of 60×1, 100×1 and 180×1 tablets
• Perforated single-dose blister packs of 14 tablets; boxes of 14×1, 56×1, 168×1 tablets

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Vivanta Generics s.r.o.

Trtinova 260/1, Cakovice,

19600, Prga 9

Czech Republic

Manufacturer:

MSN Labs Europe Ltd.,

KW20A Corradino Park,

Paola, PLA3000,

Malta

or

Pharmadox Healthcare Ltd.,

KW20A Kordin Industrial Park,

Paola, PLA3000,

Malta

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

Local representative:

Mabo-Farma S.A.

Calle Vía de los Poblados 3, Edificio 6

28033 Madrid

Spain

This medicinal product is authorised in the European Economic Area member states under the following names:

Germany: Ticagrelor Vivanta 60 mg Filmtabletten
Ticagrelor Vivanta 90 mg Filmtabletten

Cyprus: Ticagrelor MSN 60 mg, film-coated tablets
Ticagrelor MSN 90 mg, film-coated tablets

Denmark: Ticagrelor Vivanta

Spain: Ticagrelor Vivanta 60 mg comprimidos recubiertos con película EFG
Ticagrelor Vivanta 90 mg comprimidos recubiertos con película EFG

Finland: Ticagrelor Vivanta 60 mg kalvopäällysteiset tabletti
Ticagrelor Vivanta 90 mg kalvopäällysteiset tabletti

Hungary: Ticagrelor Vivanta 60 mg filmtabletta
Ticagrelor Vivanta 90 mg filmtabletta

Norway: Ticagrelor Vivanta

Netherlands: Ticagrelor Vivanta 60 mg filmomhulde tabletten
Ticagrelor Vivanta 90 mg filmomhulde tablet

Portugal: Ticagrelor Vivanta

Sweden: Ticagrelor Vivanta 60 mg filmdragerade tabletter
Ticagrelor Vivanta 90 mg filmdragerade tabletter

Date of the latest revision of this leaflet: February 2024

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