OREBRITON 60 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Orebriton, 60 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 Orebriton and what is it used for
   1. What is Orebriton
   2. What Orebriton is used for
   3. How Orebriton works
4. Important information before taking Orebriton
   1. When not to take Orebriton
   2. Warnings and precautions
   3. Children and adolescents
   4. Orebriton and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Orebriton contains sodium
5. How to take Orebriton
   1. How much to take
   2. Taking Orebriton with other blood-thinning medicines
   3. How to take Orebriton
   4. What to do if you have difficulty swallowing the tablet
   5. What to do if you take more Orebriton than you should
   6. What to do if you forget to take Orebriton
   7. What to do if you stop taking Orebriton
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. Reporting side effects
7. How to store Orebriton
8. Contents of the pack and other information
   1. What Orebriton contains
   2. What Orebriton 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:
   5. For further information, contact the representative of the marketing authorization holder in Poland:
   6. Date of last revision of the leaflet: November 2022

Package Leaflet: Information for the Patient

Orebriton, 60 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Orebriton and what is it used for

What is Orebriton

Orebriton contains the active substance ticagrelor, which belongs to a group of medicines called antiplatelet medicines.

What Orebriton is used for

Orebriton is used in combination with acetylsalicylic acid (another antiplatelet medicine) only in adults. You have been given this medicine because you have had:

• a heart attack, more than a year ago. Orebriton reduces the likelihood of having another heart attack or stroke, or dying from a heart or blood vessel condition.

How Orebriton works

Orebriton works by affecting cells in the blood called platelets (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 in blood vessels in the heart and brain, which can be very dangerous because:

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

Orebriton helps prevent platelets from clumping together, reducing the likelihood of a clot forming and reducing blood flow.

2. Important information before taking Orebriton

When not to take Orebriton

• if you are allergic to ticagrelor or any of the other ingredients of Orebriton (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 Orebriton 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 Orebriton, consult 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 are going to have surgery (including dental surgery) while taking Orebriton. This is because of an increased risk of bleeding. Your doctor may advise you to stop taking Orebriton 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 or slow breathing or shortness of breath. 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 Orebriton 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 Orebriton and heparin, as Orebriton may affect the test result.

Children and adolescents

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

Orebriton and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any you plan to take. This is because Orebriton may affect the way other medicines work, and other medicines may affect Orebriton. You must tell your doctor or pharmacist if you are taking any of the following medicines:

• rosuvastatin (a medicine used to lower cholesterol levels);
• simvastatin or lovastatin in doses greater than 40 mg per day (medicines 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), cisapride (used to treat heartburn), and ergot alkaloids (used to treat migraines and headaches).

You should also inform your doctor about taking Orebriton and the increased risk of bleeding if your doctor prescribes you fibrinolytic medicines, also known as clot-dissolving medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. Orebriton is not recommended during pregnancy or if you can become pregnant. During treatment with Orebriton, 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 Orebriton while breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Orebriton is unlikely to affect your ability to drive or use machines. However, if you experience dizziness or disorientation while taking this medicine, be careful when driving or using machines.

Orebriton contains sodium

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

3. How to take Orebriton

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

How much to take

• The usual dose of Orebriton is one 60 mg tablet twice a day. Continue taking Orebriton for as long as your doctor recommends.
• Take the medicine at the same time every day (e.g., one tablet in the morning and one in the evening).

Taking Orebriton 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 tell you what dose to take (usually between 75 and 150 mg per day).

How to take Orebriton

You can take the tablets with or without food.

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
• Pour 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 being treated in a hospital, the crushed tablet can be given through a nasogastric tube.

What to do if you take more Orebriton than you should

If you take more Orebriton 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 Orebriton

• 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 Orebriton

Do not stop taking Orebriton without talking to your doctor. You should take Orebriton regularly and for as long as your doctor recommends. Stopping Orebriton may increase the risk of having another heart attack or stroke, or dying from a heart or blood vessel condition. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Orebriton can cause side effects, although not everybody gets them. The following side effects may occur while taking this medicine: Orebriton affects blood clotting, and most side effects are related to bleeding. Bleeding can occur anywhere in the body. Some bleeding occurs frequently (e.g., bruising and nosebleeds). Severe bleeding occurs less frequently but can be life-threatening.

Seek medical help immediately 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 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 red or black (like coal)
• coughing or vomiting blood clots.
• Fainting
• temporary loss of consciousness due to a sudden decrease in blood flow to the brain (occurs frequently).
• 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.

Tell your doctor if you experience:

• Shortness of breath (dyspnea)- very common. It may be caused by heart disease or another cause, or it may be a side effect of Orebriton. Dyspnea associated with Orebriton is usually mild and characterized by sudden, unexpected shortness of breath, usually at rest, which may occur during the first few weeks of treatment and then not occur for many weeks. If shortness of breath worsens or persists, consult your doctor. Your doctor will decide if treatment or further diagnostic 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 caused by blood disorders

Common(may affect up to 1 in 10 people)

• bruising
• headache
• dizziness or lightheadedness
• diarrhea or indigestion
• nausea (feeling sick)
• constipation
• rash
• itching
• increased pain and swelling of the joints - symptoms of gout
• dizziness or lightheadedness or blurred vision - symptoms of low blood pressure
• nosebleeds
• bleeding after surgery or from cuts and wounds (e.g., during shaving) 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
• vision disturbances due to blood in the eye
• vaginal bleeding that is heavier or occurs at a different time than regular 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(frequency cannot be estimated from available data)

• abnormally low heart rate (usually less than 60 beats per minute)

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 4921 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 Orebriton

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month. There are no special storage requirements. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Orebriton contains

• The active substance is ticagrelor. Each film-coated tablet contains 60 mg of ticagrelor.
• The other ingredients are: Tablet core: mannitol, calcium hydrogen phosphate dihydrate, sodium carboxymethylcellulose (type A), hypromellose 2910, magnesium stearate. Tablet coating: hypromellose, titanium dioxide (E 171), macrogol 400, iron oxide red (E 172), iron oxide black (E 172).

What Orebriton looks like and contents of the pack

Tablet (film-coated tablet): Round, biconvex, pink tablets with a diameter of 8 mm, with the inscription "60" on one side. Carton containing a transparent blister of PVC/PVDC/Aluminum foil containing 10, 14, 28, 30, 56, 60, 100, or 168 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder: Zentiva k.s., U kabelovny 130, Dolni Mecholupy, 102 37 Prague 10, Czech Republic. Manufacturer: Labormed Pharma S.A., Bulevardul Pallady Theodor 44 B, 032266 Bucharest, Romania; Adalvo Limited, Malta Life Sciences Park, Building 1, Level 4, Sir Temi Zammit Buildings, San Gwann Industrial Estate, San Gwann, SGN 3000, Malta.

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

Estonia, Czech Republic, Poland, Greece - Orebriton; Bulgaria - Оребритон 60 mg филмирани таблетки; Croatia - Orebriton 60 mg filmom obložene tablete; Slovakia - Orebriton 60 mg; Romania - Orebriton 60 mg comprimate filmate.

For further information, contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o., ul. Bonifraterska 17, 00-203 Warsaw, phone: +48 22 375 92 00.

Date of last revision of the leaflet: November 2022