ATIRABO 90 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Atirabo, 90 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, 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. Taking Atirabo with other anti-clotting medicines
   3. How to take Atirabo
   4. What to do if you have difficulty swallowing the tablet
   5. What to do if you take more Atirabo than you should
   6. What to do if you forget to take Atirabo
   7. What to do if you stop taking Atirabo
6. Possible side effects
   1. You should immediately contact your doctor 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, 90 mg, Film-Coated Tablets

Ticagrelor

Read the package leaflet carefully before taking the medicine, 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 medicine 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 medicines called antiplatelet agents.

What Atirabo is used for

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

• myocardial infarction (heart attack) or
• unstable angina (chest pain or discomfort that is not well controlled). The medicine reduces the likelihood of having another heart attack or stroke, or dying from a heart or blood vessel-related condition.

How Atirabo works

Atirabo works by affecting platelets in the blood. Platelets are very small blood cells that help stop bleeding by clumping together and blocking small openings in blood vessels.

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

Atirabo helps prevent platelets from clumping together, reducing the likelihood of a blood clot forming and blocking 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 are currently 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:
• ketokonazol (used to treat fungal infections)
• klarytromycyna (used to treat bacterial infections)
• nefazodon (an antidepressant)
• rytonawir and atazanawir (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 serious 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 having surgery (including dental surgery) while taking Atirabo. This is because of an increased risk of bleeding. Your doctor may advise you to stop taking Atirabo 5 days before the planned surgery.
• If you have a slow heart rate (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 if 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 this 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 the medicines you are taking, or have recently taken, and any you plan to take. This is because Atirabo may affect the way other medicines work, and other medicines may affect Atirabo.

• rosuwastatin (a medicine used to lower cholesterol) or simvastatin or lovastatin in doses greater than 40 mg per day (medicines used to lower cholesterol)
• 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 irregular heartbeat)
• 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 ketokonazol (used to treat fungal infections), klarytromycyna (used to treat bacterial infections), nefazodon (an antidepressant), rytonawir and atazanawir (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 you fibrinolytic medicines, often referred to as clot-busting medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding

Atirabo should not be used during pregnancy or if you are planning to become pregnant. While taking this medicine, women should use effective contraception to avoid becoming pregnant.

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, 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. However, if you experience dizziness or disorientation while taking this medicine, be cautious when driving or using machines.

Atirabo contains sodium

This 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 starting dose is two tablets taken at the same time (loading dose of 180 mg). This dose is usually given in a hospital setting.
• After the starting dose, the usual dose is one 90 mg tablet taken twice a day for up to 12 months, unless your doctor tells you otherwise.
• 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).

Taking Atirabo with other anti-clotting medicines

Your doctor will usually recommend taking acetylsalicylic acid at the same time. This is a substance found in many anti-clotting medicines. Your doctor will tell you what dose to take (usually between 75 and 150 mg per day).

How to take Atirabo

• The tablets can be taken 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 keep track of 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.
• Put the powder into half a glass of water.
• Mix and drink immediately.
• To make sure 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. Take the medicine pack with you. 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 tells you. Stopping Atirabo may increase the risk of having another heart attack or stroke, or dying from a heart or blood vessel-related condition.

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:

You should immediately contact your doctor if you experience any of the following symptoms - you may need urgent medical attention:

• Bleeding in the brain or within 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 with no 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 extreme tiredness 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 related to Atirabo is usually mild and characterized by sudden, unexpected shortness of breath, usually 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 if 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)

• Bruising
• Headache
• Dizziness or lightheadedness
• Diarrhea or nausea
• Nausea (feeling sick)
• Constipation
• Rash
• Itching
• Increased pain and swelling of the 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 (ulcers)
• 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 due to blood in the eye
• Bleeding from the reproductive tract, which is heavier or occurs at a different time than regular menstrual bleeding
• Bleeding into the 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 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 Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects 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 stated on the packaging after EXP. The expiry date refers to the last day of that month.

There are no special storage instructions for this medicine.

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 90 mg of ticagrelor.
• The other ingredients are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, hypromellose type 2910 (6 mPas), sodium croscarmellose, magnesium stearate. Tablet coating: hypromellose type 2910 (6 mPas), titanium dioxide (E 171), talc, propylene glycol, yellow iron oxide (E 172). See section 2 "Atirabo contains sodium".

What Atirabo looks like and contents of the pack

Light yellow-brown, round, biconvex film-coated tablets (tablets) with a marking of 90 on one side.

Tablet size: diameter approximately 9 mm.

Atirabo is available in cardboard boxes containing 14, 56, 60, 100, 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 further information on this medicine, contact the local representative of the marketing authorization holder:

KRKA-POLSKA Sp. z o.o.

ul. Równoległa 5

02-235 Warsaw

telephone: +48 22 573 75 00

Date of last revision of the package leaflet: