TICAGRELOR ARISTO 90 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

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

What is ticagrelor

Ticagrelor contains the active substance ticagrelor. It belongs to a group of medicines called antiplatelet agents.

What is ticagrelor 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:

• a heart attack, more than a year ago.
• 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-related disease.

How ticagrelor works

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

Do not take ticagrelor if:

• you are allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6);
• you have a current bleeding condition;
• 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 surgery (including dental surgery, ask your dentist about this);
• you have a disorder that affects blood clotting;
• a recent stomach or intestine bleeding (such as stomach ulcer or colon ‘polyps’).

• You will be having surgery (including dental surgery) 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 (usually 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 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 platelet 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

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 seizures)
• digoxin (used to treat heart failure);
• cyclosporin (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).

Also, inform 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

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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. If you feel dizzy or confused while taking this medicine, be careful while driving or using machines.

Ticagrelor Aristo contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially ‘sodium-free’.

3. How to take Ticagrelor Aristo

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

How much to take

• 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 (for example, one tablet in the morning and one in the evening).

Taking ticagrelor with other medicines for blood clotting

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

You can take this medicine with or without food.

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 than you should

If you take more ticagrelor than you should, consult your doctor or go to the hospital immediately. Take 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

• 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

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-related 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. The following side effects may occur with this medicine:

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). Severe bleeding is rare but can be life-threatening.

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

• A bleed 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 (frequent).

• 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 unexplained 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 as if everything 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 (for example, when shaving) and injuries.
• Bleeding from the stomach walls (stomach ulcer).
• Bleeding gums.

Uncommon(may affect up to 1 in 100 people)

• Allergic reaction - a skin rash, itching, 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 into the joints and muscles that causes painful swelling.
• Bleeding in the ear.
• Internal bleeding, which can cause dizziness or fainting.

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 Monitoring 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. Storage of Ticagrelor Aristo

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 outer packaging and on the blister after ‘EXP’. 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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Ticagrelo Aristo

The active ingredient is ticagrelor.

Each tablet contains 90 mg of ticagrelor.

The other components are:

Tablet core: mannitol (E421), calcium hydrogen phosphate dihydrate, sodium starch glycolate (Type A), hypromellose, and magnesium stearate.

Coating: Opadry 03B220076 Yellow: hypromellose, titanium dioxide, macrogol 400, yellow iron oxide (E172), and talc.

Product Appearance and Container Content

Round, biconvex tablets, yellow in color, marked with '90' on one side and an approximate diameter of 9 mm.

Available in PVC-PVDC/aluminum blister packs of 10 and 14 tablets.

Packs of 14, 56, 60, 100, and 168 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Manufacturer

KeVaRo GROUP Ltd.

9, Tsaritsa Eleonora Str.,

office 23,

Sofia 1618,

Bulgaria

Or

Adalvo Limited

Malta Life Sciences Park, Building 1, Level 4

Sir Temi Zammit Buildings

San Gwann Industrial Estate

San Gwann, SGN 3000

Malta

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

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

Estonia Ticagrelor Aristo

Norway Ticagrelor Aristo 90 mg film-coated tablet

Germany Ticagrelor Aristo 90 mg film-coated tablets

Spain Ticagrelor Aristo 90 mg film-coated tablets EFG

Italy Ticagrelor Aristo 90 mg film-coated tablets

Portugal Ticagrelor Aristo

Poland Ticagrelor Aristo

Slovenia Ticagrelor Aristo 90 mg film-coated tablets

Date of the last revision of this leaflet:January 2022

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