Atirabo

Package leaflet: Information for the patient

Atirabo, 60 mg, film-coated tablets
Ticagrelor
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Atirabo is and what it is used for
2. What you need to know 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 Atirabo is and what it is used for

What Atirabo is
Atirabo contains the active substance called ticagrelor. It belongs to a group of medicines known as antiplatelet agents.

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

• a heart attack more than one year ago. The medicine reduces the likelihood of having another heart attack or stroke, or of dying due to heart- or blood vessel-related 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 sealing small openings at the site of a cut or damaged blood vessel.

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

• a clot may completely block blood flow – this may cause a heart attack (of the heart muscle) or stroke, or
• a clot may cause partial blockage of blood vessels leading to the heart – reducing blood flow to the heart and possibly causing chest pain of varying intensity (called unstable angina).

Atirabo helps prevent platelets from clumping together, thereby reducing the risk of clot formation that could impair blood flow.

2. Important Information Before Using Atirabo

When Not to Take Atirabo

• If the patient is allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6).
• If the patient is currently experiencing bleeding.
• If the patient has had a stroke caused by bleeding into the brain.
• If the patient has severe liver disease.
• If the patient is 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 infections).

Do not take Atirabo if any of the above situations apply. If in doubt, consult a doctor or pharmacist before starting treatment with this medicine.

Warnings and Precautions
Before starting Atirabo, discuss the following with your doctor or pharmacist:

• If the patient has an increased risk of bleeding due to:
  • recent serious injury
  • recent surgical procedures (including dental procedures – consult a dentist in such cases)
  • a medical condition affecting blood clotting
  • recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps).
• If the patient will undergo any surgical procedure (including dental) during treatment with Atirabo. This is due to an increased risk of bleeding. The doctor may advise stopping the medicine 5 days before the planned procedure.
• If the patient has a slow heart rate (usually less than 60 beats per minute) and does not have a pacemaker implanted.
• If the patient has asthma or other lung diseases or breathing difficulties.
• If the patient develops breathing problems such as rapid breathing, slow breathing, or apnea. The doctor will decide whether further evaluation is needed.
• If the patient has any liver disorders or has previously had a condition that could have damaged the liver.
• If blood tests have shown elevated levels of uric acid. Talk to your doctor or pharmacist before taking Atirabo if any of the above situations apply (or if you have any doubts).

If the patient is taking Atirabo together with heparin:

• The doctor may take a blood sample for diagnostic testing if heparin-induced thrombocytopenia (a rare platelet disorder) is suspected. It is important to inform the doctor about taking both Atirabo and heparin, as Atirabo may affect the diagnostic test result.

Children and Adolescents
Atirabo is not recommended for use in children and adolescents under 18 years of age.

Atirabo and Other Medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. This is important because Atirabo may affect the action of other medicines, and other medicines may affect Atirabo. Inform your doctor or pharmacist if the patient is taking any of the following medicines:

• rosuvastatin (a medicine used to lower cholesterol levels), simvastatin, or lovastatin at doses exceeding 40 mg per day (medicines used to lower 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 immune system)
• quinidine and diltiazem (used to treat heart rhythm disorders)
• beta-blockers and verapamil (used to treat hypertension)
• morphine and other opioids (used to treat severe pain).

Especially inform your doctor or pharmacist if the patient is taking any of the following medicines, which increase the risk of bleeding:

• oral anticoagulants, often called blood-thinning medicines, including warfarin
• non-steroidal anti-inflammatory drugs (NSAIDs), commonly 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), cimetidine (used to treat heartburn), ergot alkaloids (used to treat migraines and headaches).

Also inform your doctor about taking Atirabo and the increased risk of bleeding if the doctor prescribes fibrinolytic medicines, often called clot-dissolving medicines, such as streptokinase or alteplase.

Pregnancy and Breast-Feeding
Atirabo is not recommended during pregnancy or if there is a possibility of becoming pregnant. Women should use appropriate contraceptive methods while taking this medicine to avoid pregnancy.
Inform your doctor if you are breast-feeding. The doctor will discuss the benefits and risks of taking Atirabo while breast-feeding.
If the patient is pregnant or breast-feeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.

Driving and Operating Machinery
It is unlikely that Atirabo will impair the ability to drive or operate machinery. However, if dizziness or confusion occurs during treatment, caution should be exercised when driving or operating machinery.

Atirabo Contains Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Atirabo

This medicine should always be taken as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.

What dose to take

• The usual dose is one 60 mg tablet twice daily. You should continue taking Atirabo for as long as your doctor recommends.

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

Taking Atirabo with other blood-thinning medicines
Your doctor will usually recommend that you also take acetylsalicylic acid. This is a substance found in many medicines that prevent blood clotting. Your doctor will tell you what dose to take (usually between 75 and 150 mg daily).

How to take Atirabo

• Tablets may be taken with or without food.
• You can check when you last took a tablet by looking at the blister pack. The blister contains printed symbols showing a sun (for morning doses) and a moon (for evening doses). These symbols help you remember when you last took your dose.

What to do 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 the entire dose has been taken, add another half glass of water to the same container, swirl, and drink. If you are being treated in hospital, the crushed tablet may be administered via a nasogastric tube after mixing with water.

Taking more Atirabo than recommended
If you take more Atirabo than prescribed, contact your doctor immediately or go to hospital. Bring the medicine pack with you. There may be an increased risk of bleeding.

If you forget to take Atirabo

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

Stopping Atirabo
Do not stop taking Atirabo without talking to your doctor. You should take this 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.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during treatment with this medicine:
Atirabo affects blood clotting; therefore, most adverse reactions are related to bleeding. Bleeding may occur anywhere in the body. Some bleeding events are common (e.g., bruising and nosebleeds). Severe bleeding is uncommon but may be life-threatening.
Seek immediate medical attention if any of the following symptoms occur – urgent medical care may be required:

• Intracranial bleeding or bleeding into the brain is an uncommon adverse reaction and may cause stroke-like symptoms such as:
• sudden numbness or weakness in the arms, legs, or face, especially on one side of the body
• sudden confusion, difficulty speaking or understanding speech
• sudden difficulty walking, loss of balance or coordination
• sudden dizziness or sudden severe headache with no known cause
• Signs of bleeding such as:
• heavy or difficult-to-stop bleeding
• unexpected bleeding or bleeding that lasts a long time
• pink, red, or brown urine
• vomiting blood or vomit that looks like coffee grounds
• red or black, tarry stools
• coughing up or vomiting blood clots
• Fainting
• temporary loss of consciousness caused by a sudden reduction 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 fatigue or disorientation.

Discuss with your doctor if the patient experiences:

• Shortness of breath – very common. It may be caused by heart disease or another condition, or it may be an adverse reaction to Atirabo. Shortness of breath associated with Atirabo is usually mild and characterized by sudden, unexpected breathlessness, typically occurring at rest. It may appear during the first few weeks of treatment and then not recur for several weeks. If shortness of breath worsens or persists for a long time, contact your doctor. The doctor will decide whether treatment or additional tests are needed.

Other possible adverse reactions
Very common (may affect more than 1 in 10 people)

• Increased blood uric acid levels (detected in laboratory tests)
• Bleeding due to blood disorders

Common (may affect up to 1 in 10 people)

• Bruising
• Headache
• Dizziness or vertigo
• Diarrhea or indigestion
• Nausea
• Constipation
• Rash
• Itching
• Increased joint pain and swelling – symptoms of gout
• Dizziness, lightheadedness, or blurred vision – symptoms of low blood pressure
• Nosebleeds
• Bleeding after surgery or from minor cuts (e.g., during shaving) and wounds that is heavier than usual
• Bleeding from gastric mucosa (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)
• Visual disturbances due to presence of blood in the eye
• Bleeding from the genital tract that is heavier or occurs at a different time than regular menstrual bleeding
• 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 low heart rate (usually less than 60 beats per minute)

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Atirabo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the word EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Atirabo contains

• The active substance is ticagrelor. Each coated tablet contains 60 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, 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
Light pink, round, biconvex coated tablets (tablets) with the number "60" marked on one side.
Tablet dimensions: approximately 8 mm in diameter.
Atirabo is available in cardboard boxes containing 14, 56, 60, 168 or 180 coated tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation 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 about this medicinal product, please contact the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw, Poland
Telephone: +48 22 573 75 00