ATIXARSO 60 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Atixarso, 60 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Contents of the Package Leaflet
3. What is Atixarso and what is it used for
   1. What is Atixarso
   2. What is Atixarso used for
   3. How Atixarso works
4. Important information before taking Atixarso
   1. When not to take Atixarso
   2. Warnings and precautions
   3. Children and adolescents
   4. Atixarso and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Atixarso contains sodium
5. How to take Atixarso
   1. How much to take
   2. Taking Atixarso with other blood-thinning medicines
   3. How to take Atixarso
   4. What to do if you have difficulty swallowing the tablet
   5. What to do if you take more Atixarso than you should
   6. What to do if you forget to take Atixarso
   7. What to do if you stop taking Atixarso
6. Possible side effects
   1. Seek medical help immediately 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 Atixarso
8. Contents of the pack and other information
   1. What Atixarso contains
   2. What Atixarso looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicine is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the Patient

Atixarso, 60 mg, Film-Coated Tablets

Ticagrelor

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What is Atixarso and what is it 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 is Atixarso and what is it used for

What is Atixarso

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

What is Atixarso used for

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

• a heart attack, more than a year ago. The medicine reduces the likelihood of having another heart attack, stroke, or death due to a heart or blood vessel condition.

How Atixarso works

Atixarso works by affecting cells called platelets in the blood (also known as thrombocytes). Platelets are very small blood cells that help stop bleeding by clumping together and blocking small openings in blood vessels when they are cut or damaged.

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

• a clot can completely block the flow of blood - this can cause a heart attack (myocardial infarction) or stroke, or
• a clot can cause partial blockage of the blood vessels leading to the heart - this reduces blood flow to the heart and can cause chest pain that changes in severity (known as unstable angina).

Atixarso helps prevent platelets from clumping together, reducing the likelihood of a clot forming, which can reduce blood flow.

2. Important information before taking Atixarso

When not to take Atixarso

• 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:
• ketokonazole (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 applies to you. If in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking Atixarso, discuss with your doctor or pharmacist:

• If you have an increased risk of bleeding due to:
• a 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 Atixarso. This is because of an increased risk of bleeding. Your doctor may advise you to stop taking Atixarso 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 breathlessness. 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. Consult your doctor or pharmacist before taking this medicine if any of the above applies to you (or if in doubt).

If you are taking Atixarso 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 Atixarso and heparin, as Atixarso may affect the test result.

Children and adolescents

Atixarso is not recommended for children and adolescents under 18 years of age.

Atixarso and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, as Atixarso may affect the way other medicines work, and other medicines may affect Atixarso.

Tell your doctor or pharmacist if you are taking any of the following medicines:

• rosuvastatin (used to lower cholesterol levels)
• simvastatin or lovastatin in doses greater than 40 mg per day (used to lower cholesterol levels)
• 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 heart rhythm disorders)
• beta-blockers and verapamil (used to treat high blood pressure)
• morphine and other opioids (used to treat severe pain).

Particularly, tell 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 ketokonazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (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 Atixarso and have an increased risk of bleeding if your doctor prescribes fibrinolytic medicines, often referred to as clot-dissolving medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding

Atixarso should not be used during pregnancy or if you are planning to become pregnant.

While taking this medicine, women should use appropriate contraceptive methods 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 Atixarso while breastfeeding.

If you are pregnant, breastfeeding, 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

It is unlikely that Atixarso will 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.

Atixarso contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take Atixarso

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 usual dose is one 60 mg tablet twice a day. Continue taking Atixarso for as long as your doctor recommends.
• 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 Atixarso with other blood-thinning medicines

Your doctor will usually recommend taking acetylsalicylic acid at the same time. This is a substance found in many medicines that prevent blood clotting. Your doctor will inform you of the dose to take (usually between 75 and 150 mg per day).

How to take Atixarso

• 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 prints showing a sun (for morning doses) and a moon (for evening doses). These prints indicate 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 ensure you take all the medicine, refill the glass with half a glass of water, rinse, and drink. If you are being treated in a hospital, the tablet can be mixed with water and given through a nasogastric tube.

What to do if you take more Atixarso than you should

If you take more Atixarso 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 Atixarso

• 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 Atixarso

Do not stop taking Atixarso without talking to your doctor. You should take the medicine regularly and for as long as your doctor recommends. Stopping Atixarso may increase the risk of having another heart attack, stroke, or death due to a heart or blood vessel condition.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Atixarso can cause side effects, although not everybody gets them. The following side effects may occur while taking this medicine:

Atixarso affects blood clotting, and most side effects are related to bleeding. Bleeding can occur anywhere in the body. Some bleeding is common (e.g., bruising and nosebleeds). Severe bleeding is less common but can be life-threatening.

Seek medical help immediately if you experience any of the following symptoms - you may need urgent medical attention:

• Bleeding into the brain or inside the skull is an uncommon side effect and can 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 without a 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 black or tar-like
• 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 severe fatigue or confusion.

Tell your doctor if you experience:

• Shortness of breath (dyspnea) - very common. It may be caused by heart disease or another condition, or it may be a side effect of Atixarso. Dyspnea associated with Atixarso is usually mild and characterized by sudden, unexpected shortness of breath, often 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 due to blood disorders

Common (may affect up to 1 in 10 people)

• Bruising
• Headache
• Dizziness or lightheadedness
• Diarrhea or indigestion
• Nausea (vomiting)
• Constipation
• Rash
• Itching
• Increased pain and swelling of the joints - these are symptoms of gout
• Dizziness or lightheadedness or blurred vision - these are symptoms of low blood pressure
• Nosebleeds
• Bleeding after surgery or from cuts and wounds that is more 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)
• Vision disturbances due to blood in the eye
• Bleeding from the reproductive tract, which is more than usual or occurs at an unusual time (e.g., heavy or irregular menstrual bleeding)
• Bleeding into the joints and muscles, causing painful swelling
• Blood in the ear
• Internal bleeding, which can 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 leaflet, tell your doctor or pharmacist. You can also report side effects directly to the national reporting system:

Department of Drug Safety and Pharmacovigilance

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.

By reporting side effects, you can help 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 which is stated on the carton after EXP. The expiry date refers to the last day of that month.

No special storage precautions are required.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Atixarso contains

• The active substance is ticagrelor. Each film-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

Pale pink, round, biconvex film-coated tablets (tablets) with "60" marked on one side.

Tablet size: diameter approximately 8 mm.

Atixarso is available in cardboard boxes containing 14, 56, 60, 168, or 180 film-coated tablets in blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:05.04.2023