TICAGRELOR VIVANTA 60 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ticagrelor Vivanta 60 mg film-coated tablets EFG

Ticagrelor Vivanta 90 mg 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 Vivanta and what is it used for
2. What you need to know before you take Ticagrelor Vivanta
3. How to take Ticagrelor Vivanta
4. Possible side effects

5 Conservation of Ticagrelor Vivanta

1. Contents of the pack and further information

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

What is Ticagrelor Vivanta

This medicine contains the active substance ticagrelor. It belongs to a group of medicines called 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) should only be used 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 disease.

Ticagrelor Vivanta 90 mg film-coated tablets EFG

Ticagrelor in combination with acetylsalicylic acid (another antiplatelet agent) should only be used in adults. You have been prescribed this medicine because you have had:

• a heart attack, or
• unstable angina (chest pain or uncontrolled chest discomfort).

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

How Ticagrelor Vivanta works

Ticagrelor works on cells called ‘platelets’ (also called thrombocytes). These very small blood cells help stop bleeding by clumping together to block tiny 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’).

Ticagrelor 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 Vivanta

Do not take Ticagrelor Vivanta 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 ticagrelor 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 ticagrelor if:

• You have a higher risk of bleeding due to:

• a recent severe injury
• a recent surgical procedure (including dental procedures, ask your dentist about this)
• a disorder that affects blood clotting
• a recent stomach or intestinal bleeding (such as stomach ulcer or colon polyps)

• You need to have surgery (including dental procedures) at any time while taking ticagrelor. 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 (normally 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:

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

Children and adolescents

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

Other medicines and Ticagrelor Vivanta

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This is because ticagrelor 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 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 epilepsy)
• digoxin (used to treat heart failure)
• ciclosporin (used to reduce the body's immune response)
• 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 that, because you are taking ticagrelor, 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

Ticagrelor should not be used if you are pregnant or may become pregnant. Women should use appropriate contraceptive methods to avoid 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 time.

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

Ticagrelor 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.

3. How to take Ticagrelor Vivanta

Follow exactly the administration instructions of this medicine given by your doctor. 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 a day. Keep taking ticagrelor 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 Vivanta 90 mg film-coated tablets EFG

• The initial dose is two tablets at the same time (a loading dose of 180 mg). This dose will usually be given to you in the hospital.
• After this initial dose, the usual dose is one 90 mg tablet twice a day for 12 months, unless your doctor tells you otherwise.
• Take this medicine at the same time every day (e.g., one tablet in the morning and one in the evening).

Taking Ticagrelor Vivanta with other blood clotting medicines

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 Vivanta

• You can take this medicine with or without food.
• You can check when you took your last ticagrelor tablet 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 you get all the medicine, rinse the empty glass with another half 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 Vivanta than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Ticagrelor Vivanta

• 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 Vivanta

Do not stop taking ticagrelor without consulting your doctor. Take this medicine regularly and for as long as your doctor tells you. If you stop taking ticagrelor, you 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, this medicine can cause side effects, although not everybody gets them. With this medicine, the following side effects may occur:

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). Serious bleeding is uncommon but can 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 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 heart disease or another cause, or it may be a side effect of ticagrelor. Breathing difficulties related to ticagrelor are usually mild and are characterized by a sudden, unexpected need for air that usually occurs at rest and may appear in the first few weeks of treatment and in many cases may disappear. If you think your breathing difficulties have worsened or are lasting 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 the room is spinning
• Diarrhea or indigestion
• Feeling sick (nausea)
• Constipation
• Rash
• Itching
• Severe pain and swelling in the joints - these are signs of gout
• Feeling dizzy or faint, 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
• Bleeding from the stomach wall (ulcer)
• Bleeding from the 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 or irregular vaginal bleeding, or bleeding between periods
• Bleeding in the joints and muscles that causes painful swelling
• Bleeding in the ear
• Internal bleeding, which can cause dizziness or fainting

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 Medicines Surveillance System for Human Use https://www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Ticagrelor Vivanta

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container contents and additional information

• The active ingredient 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 hydroxypropylcellulose, calcium hydrogen phosphate dihydrate, hydroxypropylcellulose (E463) (contains silica), magnesium stearate (E470b).

Tablet film coating:

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).

Product appearance and container contents

Ticagrelor Vivanta 60 mg film-coated tablets EFG

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

Ticagrelor Vivanta 90 mg film-coated tablets EFG

Film-coated tablets, biconvex, round, yellow (approximately 9 mm in diameter), engraved with "90 & M" on one side and smooth 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 unit-dose blister pack of 10 tablets; boxes of 60×1 and 180×1 tablets.
• perforated unit-dose blister pack 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 unit-dose blister pack of 10 tablets; boxes of 60×1, 100×1, and 180×1 tablets.
• perforated unit-dose blister pack of 14 tablets; boxes of 14×1, 56×1, 168×1 tablets.

Only some pack sizes may be marketed.

Marketing authorization 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

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

Local representative:

Mabo-Farma S.A.

Calle Vía de los Poblados 3, Edificio 6

28033 Madrid

Spain

This medication is authorized in the member states of the European Economic Area under the following names:

Germany: Ticagrelor Vivanta 60 mg film-coated tablets

Ticagrelor Vivanta 90 mg film-coated tablets

Cyprus: Ticagrelor MSN 60 mg, film-coated tablets

Ticagrelor MSN 90 mg, film-coated tablets

Denmark: Ticagrelor Vivanta

Spain: Ticagrelor Vivanta 60 mg film-coated tablets EFG

Ticagrelor Vivanta 90 mg film-coated tablets EFG

Finland: Ticagrelor Vivanta 60 mg film-coated tablets

Ticagrelor Vivanta 90 mg film-coated tablets

Hungary: Ticagrelor Vivanta 60 mg film-coated tablets

Ticagrelor Vivanta 90 mg film-coated tablets

Norway: Ticagrelor Vivanta

Netherlands: Ticagrelor Vivanta 60 mg film-coated tablets

Ticagrelor Vivanta 90 mg film-coated tablets

Portugal: Ticagrelor Vivanta

Sweden: Ticagrelor Vivanta 60 mg film-coated tablets

Ticagrelor Vivanta 90 mg film-coated tablets

Date of the last revision of this prospectus: February 2024

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