Ticagrelor Aurovitas 90 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ticagrelor Aurovitas 60 mg film-coated tablets EFG

Ticagrelor Aurovitas 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

What Ticagrelor Aurovitas is

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

What Ticagrelor Aurovitas is used for

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:

For 60 mg:

• a myocardial infarction (heart attack) more than one year ago.

For 90 mg:

• a myocardial infarction (heart attack), or
• unstable angina (unstable chest pain or chest discomfort not adequately controlled).

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

How Ticagrelor Aurovitas works

Ticagrelor acts on blood cells called "platelets" (also known as thrombocytes). These very small blood cells help stop bleeding by clumping together to seal small holes in cut or damaged 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 forming a blood clot that could restrict blood flow.

2. What you need to know before starting to take Ticagrelor Aurovitas

Do not take Ticagrelor Aurovitas

• 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 any of the above apply to you. If you have any doubts, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take ticagrelor if:

• You have an increased risk of bleeding due to:
  • a recent serious injury.
  • a recent surgical procedure (including dental procedures; consult your dentist about this).
  • a disorder affecting blood clotting.
  • recent bleeding from the stomach or intestine (such as stomach ulcer or colon “polyps”).
• You need to undergo any surgical procedure (including dental procedures) 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 rhythm (pacemaker).
• You have asthma or other lung problems or breathing difficulties.
• 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 a previous illness 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 need to take a blood sample for diagnostic testing if he or she suspects a rare platelet disorder caused by heparin. It is important to 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 Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because ticagrelor may affect how 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).
• 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 severe 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), and ergot 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 you are given 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 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 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

Ticagrelor is unlikely to affect your ability to drive or use machines. However, if you feel dizzy or confused while taking this medicine, take care when driving or operating machinery.

Ticagrelor Aurovitas contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him or her before taking this medicine.

Ticagrelor Aurovitas contains sodium

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

3. How to take Ticagrelor Aurovitas

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

How much to take

For 60 mg:

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

For 90 mg:

• The initial dose is two tablets taken at once (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 tells you otherwise.
• Take this medicine at the same time each day (for example, one tablet in the morning and one at night).

Taking Ticagrelor Aurovitas 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 (usually between 75–150 mg daily).

How to take Ticagrelor Aurovitas

• You may 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 (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 Aurovitas 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, indicating the medicine and the amount ingested.

If you forget to take Ticagrelor Aurovitas

• 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 Aurovitas

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, 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 using 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 may be potentially fatal.

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 adverse effect, and may cause signs of stroke such as:

• sudden numbness or weakness of 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 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.

Consult 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 an adverse 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 spontaneously. 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 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 caused by blood disorders.

Common (may affect up to 1 in 10 people)

• Bruising.
• Headache.
• Dizziness or sensation of spinning (vertigo).
• Diarrhea or indigestion.
• Feeling unwell (nausea).
• Constipation.
• Rash.
• Itching.
• Severe pain and swelling in the joints – 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 (frequency 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ticagrelor Aurovitas

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

Do not use this medicine after the expiry date stated on the carton, bottle or blister pack after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ticagrelor Aurovitas

• The active substance is ticagrelor.

Each film-coated tablet contains 60 mg of ticagrelor.

Each film-coated tablet contains 90 mg of ticagrelor.

• The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose (grades 101 and 102), sodium croscarmellose, hypromellose 2910, colloidal anhydrous silica, and magnesium stearate.

Tablet coating: hypromellose 2910, macrogol 4000, calcium carbonate, iron oxide red (E172) (for the 60 mg dose), iron oxide yellow (E172) (for the 90 mg dose).

Nature of the product and contents of the pack

Ticagrelor Aurovitas 60 mg film-coated tablets EFG

Pinkish to pink, round, biconvex, film-coated tablets marked “60” on one side and “TL” on the other.

Ticagrelor Aurovitas 90 mg film-coated tablets EFG

Pale yellow to yellow, round, biconvex, film-coated tablets marked “90” on one side and “TL” on the other.

Ticagrelor Aurovitas is available in blister packs and HDPE bottles.

Pack sizes

Blister packs: 14, 30, 56, 60, 90, 100, 168, 180 and 200 film-coated tablets.

Calendar blister packs: 14, 56 and 168 film-coated tablets.

Bottles: 250 and 500 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

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

Germany: Ticagrelor PUREN 60 mg Filmtabletten
Ticagrelor PUREN 90 mg Filmtabletten

Belgium: Ticagrelor AB 60 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten
Ticagrelor AB 90 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten

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

France: TICAGRELOR ARROW 90 mg, comprimé pelliculé

Netherlands: Ticagrelor Aurobindo 60 mg, filmomhulde tabletten
Ticagrelor Aurobindo 90 mg, filmomhulde tabletten

Poland: Ticagrelor Aurovitas

Portugal: Ticagrelor Generis Phar

Date of the most recent revision of this leaflet: May 2025

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