Atixarso

Patient Information Leaflet

Atixarso, 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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 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 called ticagrelor. It belongs to a group of medicines known as 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, or
• unstable angina (chest pain or discomfort that is not adequately controlled).

The medicine reduces the likelihood of having another heart attack or stroke, or of dying due to 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 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 – 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 impair 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 experienced 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 infection and AIDS).

Do not take Atixarso 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 treatment with Atixarso, discuss 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 recommend stopping the medicine 5 days before a planned procedure.
• If the patient has a very 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, slowed breathing, or apnea. 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 elevated uric acid levels in the patient.

Talk to a doctor or pharmacist before taking Atixarso if any of the above situations apply (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 or has recently taken, as well as any medicines the patient 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 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 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 atazanavir (used to treat HIV infection and AIDS), 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 there is a possibility of becoming pregnant. Women should use appropriate contraceptive methods while taking this medicine to avoid pregnancy.

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 plans to have a child, she should consult a doctor or pharmacist before taking this medicine.

Driving and using machines
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, meaning the medicine is considered "sodium-free".

3. How to use Atixarso

This medicine should always be taken exactly as instructed by your doctor or pharmacist. If you are unsure,
please consult your doctor or pharmacist.
What dose to take

• The initial dose is two tablets taken at the same time (loading dose of 180 mg). This dose is usually administered in hospital.
• After the initial dose, the usual 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 Atixarso 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 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 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, 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, add another half glass of water to the container, swirl, and drink. If the patient is being treated in hospital, the crushed tablet dissolved in water may be administered via a nasal tube (nasogastric tube).

Taking more Atixarso than recommended
If you take more Atixarso than recommended, contact your doctor immediately or go to hospital.
Bring the medicine pack with you. There may be an increased risk of bleeding.
If you miss a dose of 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 must take the medicine regularly and for as long as your doctor advises. Stopping Atixarso 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, 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 is uncommon but may be life-threatening.
Seek immediate medical advice if any of the following symptoms occur – urgent medical assistance 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 material that looks like coffee grounds
• stools that are 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.

Discuss with the doctor if the patient experiences:

• Shortness of breath – very common. This may be due to heart disease or another cause, or may be an adverse reaction to Atixarso. Shortness of breath associated with Atixarso 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 the doctor. The doctor will decide whether treatment or additional investigations are necessary.

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

• Increased uric acid levels in blood (detected in laboratory tests)
• Bleeding due to 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 minor wounds (e.g. during shaving) 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 caused by 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 a doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Atixarso

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the EXP abbreviation. The expiry date refers to the last day of the specified month.
No special storage instructions 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 required. Such measures will help protect the environment.

6. Contents of the pack and other information

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

What Atixarso looks like and contents of the pack
Light brownish-yellow, round, biconvex coated tablets (tablets) with the marking "90" on one side.
Tablet dimensions: approximately 9 mm in diameter.
Atixarso 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 and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This medicinal product is authorised for marketing in the European Economic Area countries under the following names: