Orebriton

Package leaflet: Information for the patient

Orebriton, 60 mg, film-coated tablets
Ticagrelor
Please read all of this leaflet carefully before taking this medicine, because 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.

Contents of the leaflet

1. What Orebriton is and what it is used for
2. What you need to know 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 Orebriton is and what it is used for

What Orebriton is
Orebriton contains an active substance called ticagrelor. It belongs to a group of medicines known as antiplatelet agents.

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

• a heart attack more than one year ago. The medicine reduces the likelihood of having another heart attack or stroke, or of dying from a heart- or blood vessel-related disease.

How Orebriton works
Orebriton 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 openings at the site of a cut or damaged blood vessel.

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 – this can cause a heart attack (myocardial infarction) or stroke, or
• a clot may partially block blood vessels leading to the heart, reducing blood flow to the heart and possibly causing chest pain that varies in intensity (known as unstable angina).

Orebriton helps prevent platelets from clumping together, thereby reducing the risk of forming clots that could impair blood flow.

2. Important information before using Orebriton

When not to use Orebriton

• if the patient is allergic to ticagrelor or any of the other ingredients of Orebriton (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 Orebriton 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 taking Orebriton, consult a doctor or pharmacist:

• if the patient has an increased risk of bleeding due to:
  • a 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 procedure (including dental) during treatment with Orebriton. 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 needed;
• if the patient has any liver problems or has previously had a disease that may have damaged the liver;
• if blood tests have shown high levels of uric acid in the patient's blood. Talk to a doctor or pharmacist before taking Orebriton if any of the above situations apply (or if in doubt).

If the patient is taking Orebriton and heparin at the same time:

• 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 Orebriton and heparin, as Orebriton may affect the diagnostic test result.

Children and adolescents
Orebriton is not recommended for use in children and adolescents under 18 years of age.
Orebriton and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This is necessary because Orebriton may affect the action of other medicines, and other medicines may affect Orebriton.
Inform your doctor or pharmacist if you are 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 your doctor or pharmacist if you are 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 and AIDS infections), cimetidine (used to treat heartburn), 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 fibrinolytic medicines, often called clot-dissolving medicines, such as streptokinase or alteplase.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Orebriton is not recommended during pregnancy or if there is a possibility of becoming pregnant.
Women of childbearing potential should use appropriate contraceptive methods during treatment to avoid pregnancy.
Inform the doctor before using this medicine if breastfeeding. The doctor will discuss the benefits and risks associated with using Orebriton during breastfeeding.
Driving and operating machinery
It is unlikely that Orebriton will impair the ability to drive or operate machinery. However, if dizziness or disorientation occurs during treatment, caution should be exercised when driving or operating machinery.
Orebriton contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose and is considered "sodium-free".

3. How to use Orebriton

This medicine should always be used as prescribed by your doctor. If in doubt,
contact your doctor or pharmacist.
What dose to use

• The usual dose is one 60 mg tablet twice daily. You should continue taking Orebriton for as long as your doctor recommends.
• This medicine should be taken every day at the same time (e.g. one tablet in the morning and one in the evening).

Taking Orebriton with other blood-thinning medicines
Your doctor will usually recommend that you also take acetylsalicylic acid. This is a 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 Orebriton
Tablets may be taken with or without food.
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 entire dose is taken, pour another half glass of water, swirl and drink. If the patient is being treated in hospital, the tablet may be administered through a nasogastric tube after being dissolved in water.

Taking more Orebriton than prescribed
If you take more Orebriton than prescribed, contact your doctor immediately or go to hospital.
Bring the medicine packaging with you. There may be an increased risk of bleeding.
If you miss a dose of Orebriton

• 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 treatment with Orebriton
Do not stop taking Orebriton without talking to your doctor. You should take this medicine regularly
and for as long as your doctor recommends. Stopping this medicine 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, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following adverse effects may occur during treatment with this medicine:
Orebriton affects blood clotting, therefore most adverse effects 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.
You should contact your doctor immediately if any of the following symptoms occur – urgent medical assistance may be required:

• Bleeding into the brain or intracranial haemorrhage is an uncommon adverse effect and may cause stroke-like symptoms such as:
  • sudden numbness or weakness in arms, legs or face, especially if affecting only 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.
• Symptoms of bleeding such as:
  • heavy bleeding or bleeding difficult to stop
  • unexpected bleeding or bleeding lasting a long time
  • urine discoloured pink, red or brown
  • vomiting blood or material that looks like coffee grounds
  • stools coloured red or black (resembling tar)
  • coughing 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.

You should discuss with your doctor if the patient experiences:

• Shortness of breath (dyspnoea) – very common. It may be caused by heart disease or another condition, or may be an adverse effect of Orebriton. Dyspnoea associated with Orebriton treatment 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 your doctor. The doctor will decide whether treatment or additional diagnostic tests are necessary.

Other possible adverse effects
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 vertigo
• 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
• visual disturbances caused by blood in the eye
• vaginal bleeding 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 4921 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the responsible entity.
Reporting adverse effects helps to 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 pack and the outer cardboard
pack after EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
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 Orebriton contains

• The active substance is ticagrelor. Each coated tablet contains 60 mg of ticagrelor.
• Other ingredients are:
  Tablet core: mannitol, calcium hydrogen phosphate dihydrate, sodium carboxymethyl starch (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
Film-coated tablet (tablet): Round, biconvex, pink tablets with a diameter of 8 mm, marked with "60" engraved on one side.
Carton box containing a transparent PVC/PVDC/Aluminum blister with 10, 14, 28, 30, 56, 60, 100 or 168 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zentiva k.s.
U kabelovny 130
Dolni Mecholupy
102 37 Prague 10
Czech Republic

Manufacturers:
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 medicinal product is authorised in 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, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel.: +48 22 375 92 00