Atixarso

Patient Information Leaflet

Atixarso, 60 mg, film-coated tablets
ticagrelor
Please read all of 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 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 adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

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

1. What Atixarso is and what it is used for

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

What Atixarso is used for
Atixarso, 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 risk of having another heart attack or stroke, or of dying from a heart- or blood vessel-related disease.

How Atixarso works
Atixarso 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 cuts or damage in blood vessels.

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 – which can lead to a heart attack (myocardial infarction) 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 that varies in intensity (called unstable angina).

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

2. Important information before using Atixarso

When not to take Atixarso

• 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 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 Atixarso 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 to take Atixarso, discuss this 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 condition affecting blood clotting
• recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps).
• If the patient will undergo any surgical procedures (including dental procedures) during treatment with Atixarso. 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 apnoea. The doctor will decide whether further evaluation is necessary.
• If the patient has any liver disorders or has previously had a disease that could have damaged the liver.
• If blood tests have shown high levels of uric acid in the patient. Talk to a doctor or pharmacist before taking Atixarso if any of the above situations apply to the patient (or if in doubt).

If the patient is taking both Atixarso and 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 Atixarso and heparin, as Atixarso may affect the diagnostic test result.

Children and adolescents
Atixarso is not recommended for use in children and adolescents under 18 years of age.
Atixarso 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 Atixarso may affect the action of other medicines, and other medicines may affect Atixarso. Inform the doctor or pharmacist if the patient is taking any of the following medicines:

• rosuvastatin (a medicine used to reduce cholesterol levels)
• simvastatin or lovastatin at doses higher than 40 mg daily (medicines used to reduce 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 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 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), cimetidine (used to treat heartburn), ergot alkaloids (used to treat migraines and headaches).

Also inform the doctor about taking Atixarso 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
Atixarso is not recommended during pregnancy or if pregnancy is possible. Women should use appropriate contraceptive methods while taking this medicine to avoid becoming pregnant.
Inform the doctor before taking this medicine if breastfeeding. The doctor will discuss the benefits and risks of using Atixarso during breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before taking this medicine.
Driving and operating machinery
It is unlikely that Atixarso 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.
Atixarso contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to use Atixarso

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

• The usual dose is one 60 mg tablet twice daily. You should continue taking Atixarso 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 Atixarso with other blood-thinning medicines
Your doctor will usually recommend taking acetylsalicylic acid at the same time. This is an active
substance 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 Atixarso

• 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 indicating the sun (for morning doses) and the 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, it may be crushed and mixed 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, pour another half glass of water, swirl and drink. If the patient is being treated in hospital, the tablet dissolved in water may be administered via a nasogastric tube.

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

• 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 Atixarso
Do not stop taking Atixarso without talking to your doctor. You should take the medicine regularly
and for as long as your doctor advises. Stopping Atixarso 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, please 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:
Atixarso 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 occurs less frequently but may be life-threatening.
Contact a 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 of the arms, legs or face, especially on 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 with no known cause
• Signs of bleeding such as:
• heavy bleeding or bleeding that is difficult to stop
• unexpected bleeding or bleeding that lasts a long time
• urine that is pink, red or brown in colour
• vomiting blood or vomit that looks like coffee grounds
• red or black (tarry-looking) stools
• coughing up or vomiting blood clots
• Fainting
• temporary loss of consciousness caused by a sudden reduction in blood flow to the brain (this is 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 the doctor if the patient experiences:

• shortness of breath – this is very common. It may be caused by heart disease or another condition, or it may be an adverse reaction to Atixarso. Shortness of breath associated with Atixarso is usually mild and is characterised by sudden, unexpected breathlessness, usually 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 a doctor. The doctor will decide whether treatment or further investigations 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
• Headaches
• Dizziness or spinning sensation
• Diarrhoea 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 cuts (e.g. during shaving) and wounds that is heavier 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)
• Visual disturbances due to presence of blood in the eye
• Bleeding from the genital tract that is heavier than usual 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, tell a doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions
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 may 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 Atixarso

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 EXP. The expiry date refers to the last day of the stated month.
No special storage conditions for this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the packaging and other information

What Atixarso 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, sodium croscarmellose, magnesium stearate.
  Tablet coating: hypromellose type 2910, titanium dioxide (E 171), talc, propylene glycol, iron oxide red (E 172), iron oxide black (E 172). See section 2 "Atixarso contains sodium".

What Atixarso looks like and contents of the pack
Light pink, round, biconvex coated tablets (tablets) with the number 60 engraved on one side.
Tablet dimensions: approximately 8 mm in diameter.
Atixarso 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 and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

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