Atirabo

Patient Information Leaflet

Atirabo, 90 mg, film-coated tablets
Ticagrelor
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not share it with others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents

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, or
• unstable angina (chest pain or discomfort that is not adequately controlled).

The medicine reduces the risk of having another heart attack or stroke, or of dying from 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 blood vessel injury.

However, platelets can 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 – leading to a heart attack (myocardial infarction) or stroke, or
• a clot may partially block blood vessels leading to the heart – reducing blood flow to the heart and causing chest pain of varying intensity (called unstable angina).

Atirabo helps prevent platelets from clumping together, thereby reducing the risk of forming a clot 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 atazanawir (used to treat HIV and AIDS infections).

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

Warnings and precautions
Before starting Atirabo, discuss the following with a 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 regarding this)
• a medical condition affecting blood clotting
• recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps).
• If the patient will undergo any surgical procedures (including dental) during treatment with Atirabo. This is due to an increased risk of bleeding. The doctor may recommend discontinuing 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 cardiac 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 necessary.
• 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 in the patient. Talk to a doctor or pharmacist before taking Atirabo if any of the above situations apply (or if in doubt).

If the patient is taking Atirabo and heparin simultaneously:

• The doctor may take a blood sample for diagnostic testing if heparin-induced thrombocytopenia 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 with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. This is necessary because Atirabo may affect the action of other medicines, and other medicines may affect Atirabo. Inform the doctor or pharmacist if the patient is taking any of the following medicines:

• rosuvastatin (a medicine used to reduce cholesterol levels), or simvastatin or lovastatin at doses exceeding 40 mg daily (medicines used to reduce cholesterol levels)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine, and phenobarbital (used to control 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 high blood pressure)
• morphine and other opioids (used to treat severe pain).

Especially inform the 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 atazanawir (used to treat HIV and AIDS infections), cisapride (used to treat heartburn), ergot alkaloids (used to treat migraines and headaches).

Also inform the 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 breastfeeding
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 the doctor if the patient is breastfeeding. The doctor will discuss the benefits and risks associated with using Atirabo during breastfeeding.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
It is unlikely that Atirabo will impair the ability to drive or operate machinery. However, if dizziness or disorientation 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 it is considered "sodium-free".

3. How to use Atirabo

This medicine should always be used exactly as prescribed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
What dose to use

• The initial dose is two tablets taken at the same time (loading dose of 180 mg). This dose is usually administered in a hospital.
• After the initial dose, the usual maintenance dose is one 90 mg tablet taken twice daily for up to 12 months, unless your doctor advises otherwise.
• 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 taking acetylsalicylic acid at the same time. This is an ingredient
found in many medicines that prevent blood clotting. Your doctor will advise you on the 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 patients remember when they last took their 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.
• Mix and drink immediately.
• To ensure the full dose is 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 dissolving in water.

Taking more Atirabo than recommended
If you take more Atirabo than prescribed, contact your doctor immediately or go to the nearest hospital.
Take 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 the medicine regularly and for as long as your doctor recommends. Stopping Atirabo treatment may increase the risk of having another heart attack or stroke, or of dying from a heart or blood vessel-related condition.
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 medicinal product may cause adverse reactions, although not everyone experiences 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.
You should contact your doctor immediately if any of the following symptoms occur – urgent medical care may be required:

• Intracranial haemorrhage (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 if affecting only one side of the body
• sudden confusion, difficulty speaking or understanding others
• sudden difficulty walking, loss of balance or coordination
• sudden dizziness or sudden severe headache without known cause
• Symptoms of bleeding such as:
• heavy or severe bleeding that is difficult to stop
• unexpected bleeding or bleeding that lasts a long time
• urine discoloured pink, red, or brown
• vomiting blood or material that looks like coffee grounds
• stools coloured red or black (resembling tar)
• 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.

You should discuss with your doctor if the patient experiences:

• shortness of breath (dyspnoea) – very common. It may be caused by heart disease or another condition, or may be an adverse reaction to Atirabo. Dyspnoea associated with Atirabo is usually mild and characterised by sudden, unexpected breathlessness, usually at rest, which may occur 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 further investigations are necessary.

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

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

Common (may affect up to 1 in 10 people)

• Bruising
• Headaches
• Dizziness or vertigo
• Diarrhoea or indigestion
• Nausea
• Constipation
• Rash
• Itching
• Intense joint pain and swelling – symptoms of gout
• Dizziness, lightheadedness, or blurred vision – symptoms of low blood pressure
• Nosebleeds
• Bleeding after surgery or from cuts (e.g. during shaving) that is heavier than usual
• Bleeding from the 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 caused by presence of blood in the eye
• Bleeding from the reproductive 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, 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

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 the abbreviation
EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply to this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the package and other information

What Atirabo contains

• The active substance is ticagrelor. Each 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, iron oxide yellow (E 172). See section 2 "Atirabo contains sodium".

What Atirabo looks like and contents of the pack
Light brownish-yellow, round, biconvex coated tablets (tablets) with the number 90 marked on one side.
Tablet dimensions: diameter approximately 9 mm.
Atirabo is available in cardboard boxes containing 14, 56, 60, 100, 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 medicine, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
telephone: +48 22 573 75 00