ATIRABO 60 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Atirabo, 60 mg, Film-Coated Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Package Leaflet
3. What is Atirabo and what is it used for
   1. What is Atirabo
   2. What Atirabo is used for
   3. How Atirabo works
4. Important information before taking Atirabo
   1. When not to take Atirabo
   2. Warnings and precautions
   3. Children and adolescents
   4. Atirabo and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Atirabo contains sodium
5. How to take Atirabo
   1. How much to take
   2. What to do if you have difficulty swallowing the tablet
   3. What to do if you take more Atirabo than you should
   4. What to do if you forget to take Atirabo
   5. What to do if you stop taking Atirabo
6. Possible side effects
   1. Seek medical help immediately if you experience any of the following symptoms - you may need urgent medical attention:
   2. Tell your doctor if you experience:
   3. Other possible side effects
   4. Very common (may affect more than 1 in 10 people)
   5. Common (may affect up to 1 in 10 people)
   6. Uncommon (may affect up to 1 in 100 people)
   7. Frequency not known (cannot be estimated from the available data)
   8. Reporting side effects
7. How to store Atirabo
8. Contents of the pack and other information
   1. What Atirabo contains
   2. What Atirabo looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the package leaflet:

Package Leaflet: Information for the Patient

Atirabo, 60 mg, Film-Coated Tablets

Ticagrelor

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Atirabo and what is it used for
• 2. Important information before taking Atirabo
• 3. How to take Atirabo
• 4. Possible side effects
• 5. How to store Atirabo
• 6. Contents of the pack and other information

1. What is Atirabo and what is it used for

What is Atirabo

Atirabo contains the active substance ticagrelor, which belongs to a group of antiplatelet medicines.

What Atirabo is used for

Atirabo is used in combination with acetylsalicylic acid (another antiplatelet medicine) only in adults who have had:

• myocardial infarction more than a year ago. The medicine reduces the likelihood of another myocardial infarction or stroke, or death due to heart or blood vessel disease.

How Atirabo works

Atirabo affects blood cells called platelets (also known as thrombocytes). Platelets are very small blood cells that help stop bleeding by clumping together and blocking small openings in damaged blood vessels.

However, platelets can also form clots inside blood vessels in the heart and brain, which can be very dangerous because:

• a clot can completely block the flow of blood, which can cause a heart attack (myocardial infarction) or stroke, or
• a clot can cause partial blockage of blood vessels leading to the heart, reducing blood flow to the heart and causing chest pain that changes in severity (known as unstable angina).

Atirabo helps prevent platelets from clumping together, reducing the likelihood of a clot forming that could reduce blood flow.

2. Important information before taking Atirabo

When not to take Atirabo

• If you are allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6).
• If you have active bleeding.
• If you have had a stroke caused by bleeding in the brain.
• If you have severe liver disease.
• If you are taking any of the following medicines:
• ketokonazole (used to treat fungal infections)
• clarithromycin (used to treat bacterial infections)
• nefazodone (an antidepressant)
• ritonavir and atazanavir (used to treat HIV and AIDS infections). Do not take Atirabo if any of the above applies to you. If in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking Atirabo, discuss with your doctor or pharmacist:

• If you have an increased risk of bleeding due to:
• recent severe injury
• recent surgery (including dental surgery - consult your dentist)
• a condition that affects blood clotting
• recent bleeding from the stomach or intestines (such as stomach ulcers or intestinal polyps).
• If you will be undergoing surgery (including dental surgery) while taking Atirabo. This is due to an increased risk of bleeding. Your doctor may advise you to stop taking the medicine 5 days before the planned surgery.
• If you have a heart rate that is too slow (usually less than 60 beats per minute) and do not have a pacemaker.
• If you have asthma or other lung diseases or breathing difficulties.
• If you develop breathing difficulties such as rapid breathing, slow breathing, or shortness of breath. Your doctor will decide whether further evaluation is needed.
• If you have any liver problems or have had a disease that may have damaged your liver.
• If your blood test shows high levels of uric acid. Inform your doctor or pharmacist before taking the medicine if any of the above applies to you (or if in doubt).

If you are taking Atirabo and heparin:

• Your doctor may take a blood sample for diagnostic tests if they suspect a rare platelet disorder caused by heparin. It is essential to inform your doctor that you are taking both Atirabo and heparin, as Atirabo may affect the test result.

Children and adolescents

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

Atirabo and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, as Atirabo may affect the way other medicines work, and other medicines may affect Atirabo.

• rosuvastatin (a medicine used to lower cholesterol levels), simvastatin, or lovastatin in doses greater than 40 mg per day (medicines used to lower cholesterol levels)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine, and phenobarbital (used to control seizures)
• digoxin (used to treat heart failure)
• cyclosporin (used to weaken the immune system)
• quinidine and diltiazem (used to treat heart rhythm disorders)
• beta-blockers and verapamil (used to treat high blood pressure)
• morphine and other opioids (used to treat severe pain).

Particularly inform 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), often used as painkillers, such as ibuprofen and naproxen
• selective serotonin reuptake inhibitors (SSRIs), used 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 infections), cisapride (used to treat heartburn), and ergot alkaloids (used to treat migraines and headaches).

Also, inform your doctor if you are taking Atirabo and have an increased risk of bleeding if your doctor prescribes fibrinolytic medicines, often referred to as clot-dissolving medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding

Atirabo should not be taken during pregnancy or if you are planning to become pregnant.

Women should use effective contraception to avoid becoming pregnant while taking Atirabo.

Before taking this medicine, inform your doctor if you are breastfeeding. Your doctor will discuss the benefits and risks of taking Atirabo while 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.

Driving and using machines

Atirabo is unlikely to affect your ability to drive or use machines. If you experience dizziness or disorientation while taking the medicine, be careful when driving or using machines.

Atirabo contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take Atirabo

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

How much to take

• The usual dose is one 60 mg tablet twice a day. You should continue to take Atirabo for as long as your doctor recommends.

It is recommended to take the medicine at the same time every day (e.g., one tablet in the morning and one in the evening).

• Take the medicine with or without food.
• You can check when you last took a tablet by looking at the blister pack. The blister pack has a sun symbol (for morning doses) and a moon symbol (for evening doses) to help you remember when you took your last dose.

What to do 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.
• Mix and drink immediately.
• To ensure you take all the medicine, add another half glass of water, stir, and drink. If you are in the hospital, the crushed tablet can be given through a nasogastric tube.

What to do if you take more Atirabo than you should

If you take more Atirabo than you should, contact your doctor or go to the hospital immediately. You may be at risk of bleeding.

What to do if you forget to take Atirabo

• If you forget to take a dose, take the next dose at the usual time.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

What to do if you stop taking Atirabo

Do not stop taking Atirabo without talking to your doctor. You should take the medicine regularly and for as long as your doctor recommends. Stopping Atirabo may increase the risk of another heart attack or stroke, or death due to heart or blood vessel disease.

4. Possible side effects

Like all medicines, Atirabo can cause side effects, although not everybody gets them.

The following side effects may occur while taking this medicine:

Atirabo affects blood clotting, and most side effects are related to bleeding. Bleeding can occur anywhere in the body. Some bleeding is common (e.g., bruising and nosebleeds). Severe bleeding is less common but can be life-threatening.

Seek medical help immediately if you experience any of the following symptoms - you may need urgent medical attention:

• Bleeding in the brain or inside the skull is an uncommon side effect and may cause stroke-like symptoms, such as:
• sudden numbness or weakness of the arms, legs, or face, especially if it occurs on one side of the body
• sudden confusion, difficulty speaking or understanding others
• sudden difficulty walking, loss of balance, or coordination
• sudden dizziness or severe headache without a known cause
• Bleeding symptoms, such as:
• heavy or prolonged bleeding
• unexpected or prolonged bleeding
• urine that is pink, red, or brown
• vomiting blood or coffee-ground-like material
• stool that is red or black (like tar)
• coughing or vomiting blood clots
• Fainting
• temporary loss of consciousness due to a sudden decrease in blood flow to the brain (common)
• Symptoms related to 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 severe fatigue or confusion.

Tell your doctor if you experience:

• Shortness of breath (dyspnea) - very common. It may be caused by heart disease or another cause, or it may be a side effect of Atirabo. Dyspnea associated with Atirabo is usually mild and characterized by sudden, unexpected shortness of breath, often at rest, which may occur during the first few weeks of treatment and then not occur for many weeks. If dyspnea worsens or persists, contact your doctor. Your doctor will decide whether treatment or further tests are needed.

Other possible side effects

Very common (may affect more than 1 in 10 people)

• Increased uric acid levels in the blood (found in laboratory tests)
• Bleeding caused by blood disorders

Common (may affect up to 1 in 10 people)

• Formation of bruises
• Headaches
• Dizziness or feeling of spinning
• Diarrhea or indigestion
• Nausea (feeling sick)
• Constipation
• Rash
• Itching
• Increased pain and swelling of joints - symptoms of gout
• Dizziness or lightheadedness - symptoms of low blood pressure
• Nosebleeds
• Bleeding after surgery or from cuts and wounds that is more than usual
• Bleeding from the stomach lining (ulcer)
• Bleeding gums

Uncommon (may affect up to 1 in 100 people)

• Allergic reaction - rash, itching, swelling of the face or lips/tongue may be signs of an allergic reaction
• Disorientation (confusion)
• Vision disturbances caused by blood in the eye
• Bleeding from the reproductive tract, which is more than usual or occurs at an unusual time (e.g., heavy or irregular menstrual bleeding)
• Bleeding into joints and muscles, causing painful swelling
• Blood in the ear
• Internal bleeding, which can cause dizziness or lightheadedness

Frequency not known (cannot be estimated from the available data)

• Abnormally low heart rate (usually less than 60 beats per minute)

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the national reporting system via the Medicines Agency website or to the marketing authorization holder.

5. How to store Atirabo

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 packaging after EXP. The expiry date refers to the last day of the month.

No special precautions for storage are necessary.

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

6. Contents of the pack and other information

What Atirabo contains

• The active substance is ticagrelor. Each film-coated tablet contains 60 mg of ticagrelor.
• The other ingredients are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, hypromellose type 2910 (6 mPas), croscarmellose sodium, magnesium stearate. Tablet coating: hypromellose type 2910 (6 mPas), titanium dioxide (E 171), talc, propylene glycol, iron oxide red (E 172), iron oxide black (E 172). See section 2 "Atirabo contains sodium".

What Atirabo looks like and contents of the pack

Pale pink, round, biconvex film-coated tablets (tablets) with a marking of 60 on one side.

Tablet size: diameter approximately 8 mm.

Atirabo is available in cardboard boxes containing 14, 56, 60, 168, or 180 film-coated tablets in blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For more information about this medicine, contact the local representative of the marketing authorization holder:

KRKA-POLSKA Sp. z o.o.

ul. Równoległa 5

02-235 Warszawa

telephone: + 48 22 573 75 00

Date of last revision of the package leaflet: