ATIXARSO 90 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Atixarso, 90 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Table of 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 with 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 anti-clotting medicines
   3. How to take Atixarso
   4. What to do if you have trouble 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 immediate medical attention 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 of 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, 90 mg, Film-Coated Tablets

Ticagrelor

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

• Keep this 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 experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of 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, which belongs to a group of medicines called antiplatelet agents.

What is Atixarso used for

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

• myocardial infarction (heart attack) or
• unstable angina (chest pain or discomfort which is not well controlled).

Atixarso reduces the risk of having another heart attack or stroke, or dying from a heart or blood vessel-related problem.

How Atixarso works

Atixarso works by affecting cells in the blood called platelets. Platelets are very small blood cells which help to stop bleeding by clumping together to form a blood clot.

However, platelets can also form clots in the blood vessels of the heart and brain, which can lead to a heart attack or stroke.

• a clot can completely block the blood flow - this can cause a heart attack (myocardial infarction) or stroke, or
• a clot can partially block the blood flow to the heart - this reduces blood flow to the heart and can cause chest pain (unstable angina).

Atixarso helps to prevent platelets from clumping together and forming clots, reducing the risk of a clot blocking the 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). Do not take Atixarso if any of the above apply to you. If you are in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking Atixarso, tell 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).
• you are going to have surgery (including dental surgery) while taking Atixarso. This is because you may be at increased risk of bleeding. Your doctor may advise you to stop taking Atixarso 5 days before the planned surgery.
• you have a slow heart rate (usually less than 60 beats per minute) and do not have a pacemaker.
• you have asthma or other lung diseases or breathing difficulties.
• you develop breathing difficulties such as rapid breathing, slow breathing or pauses in breathing. Your doctor will decide if further evaluation is needed.
• you have any liver problems or have had a disease in the past that may have damaged your liver.
• you have high levels of uric acid in your blood. Tell your doctor or pharmacist if any of the above apply to you (or if you are unsure).

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 important to inform your doctor that you are taking both Atixarso and heparin, as Atixarso may affect the results of the diagnostic test.

Children and adolescents

Atixarso should not be used in children and adolescents under 18 years of age.

Atixarso with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and any you plan to take.

• 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 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 tell your doctor or pharmacist if you are taking any of the following medicines that 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 ketokonazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (used to treat HIV and AIDS), cisapride (used to treat heartburn), and ergot alkaloids (used to treat migraines and headaches).

Also tell your doctor if you are taking Atixarso and have an increased risk of bleeding, if your doctor prescribes you fibrinolytic medicines (often called clot-busting 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 Atixarso, women should use appropriate contraceptive methods to prevent pregnancy.

Before taking this medicine, tell your doctor if you are breastfeeding. Your doctor will discuss the benefits and risks of taking Atixarso while breastfeeding.

If you are pregnant or 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 confusion while taking Atixarso, be careful 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 unsure, ask your doctor or pharmacist.

How much to take

• The starting dose is two tablets taken at the same time (loading dose of 180 mg). This dose is usually given in a hospital.
• After the starting dose, the usual dose is one 90 mg tablet twice a day for up to 12 months, unless your doctor tells you otherwise.
• 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 anti-clotting medicines

Your doctor will usually advise you to take acetylsalicylic acid at the same time as Atixarso.

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 per day).

How to take Atixarso

• You can take the tablets with or without food.
• You can check when you last took a tablet by looking at the blister pack.
• The blister pack has a sun symbol (for morning doses) and a moon symbol (for evening doses) to help you remember when you last took a dose.

What to do if you have trouble swallowing the tablet

If you have trouble 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 make sure you take all the medicine, refill the glass with half a glass of water, swirl and drink.
• If you are in 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 increased 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 first.

Take the medicine regularly and for as long as your doctor tells you.

Stopping Atixarso may increase the risk of having another heart attack or stroke, or dying from a heart or blood vessel-related problem.

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 Atixarso:

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 immediate medical attention if you experience any of the following symptoms - you may need urgent medical attention:

• Bleeding in the brain or within the skull is an uncommon side effect and may 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 with no known cause
• Bleeding symptoms, such as:
• heavy or prolonged bleeding
• unexpected bleeding or bleeding that lasts a long time
• urine that is pink, red or brown
• vomiting blood or material that looks like coffee grounds
• stools that are black or tarry
• coughing or vomiting blood clots
• Fainting
• temporary loss of consciousness due to a sudden drop in blood flow to the brain (common)
• Thrombotic thrombocytopenic purpura (TTP) symptoms, 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 tiredness or confusion.

Tell your doctor if you experience:

• Shortness of breath (dyspnoea) - very common. This may be caused by heart disease or other conditions, or it may be a side effect of Atixarso.

Other possible side effects

Very common (may affect more than 1 in 10 people)

• Increased levels of uric acid in the blood (found in laboratory tests)
• Bleeding caused by blood disorders

Common (may affect up to 1 in 10 people)

• Bruising
• Headache
• Dizziness or lightheadedness
• Diarrhoea or indigestion
• Nausea (feeling sick)
• 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 (stomach ulcers)
• 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
• Confusion (disorientation)
• Vision disturbances due to bleeding in the eye
• Bleeding from the reproductive organs, which is more than usual or occurs at an unusual time (e.g. heavy or irregular menstrual periods)
• Bleeding into the joints and muscles, causing painful swelling
• Blood in the ear
• Internal bleeding, which may 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 of side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.

Side effects can be reported directly to the

Department of Medicinal Product Monitoring

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

Side effects can also be reported 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 pack after EXP.

The expiry date refers to the last day of that month.

No special storage precautions are required.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.

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 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, yellow iron oxide (E 172). See section 2 "Atixarso contains sodium".

What Atixarso looks like and contents of the pack

Light yellowish-brown, round, biconvex film-coated tablets (tablets) with the mark 90 on one side.

Tablet size: diameter approximately 9 mm.

Atixarso is available in cardboard boxes containing 14, 56, 60, 100, 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 package leaflet: 05.04.2023