Ticagrelor Olpha

Leaflet accompanying the packaging: patient information

Ticagrelor Olpha, 60 mg, coated tablets

Ticagrelor

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and is intended for your use only. Do not give it to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Ticagrelor Olpha and what is it used for

What is Ticagrelor Olpha

Ticagrelor Olpha contains the active substance ticagrelor, which belongs to a group of antiplatelet medicines.

What is Ticagrelor Olpha used for

Ticagrelor Olpha 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 another heart attack or stroke, or death due to heart or blood vessel disease.

How Ticagrelor Olpha works

Ticagrelor Olpha works by affecting blood cells called platelets (also known as thrombocytes). Platelets are very small blood cells that help stop bleeding by clumping together and blocking small holes in injured blood vessels. However, platelets can also form clots inside diseased blood vessels in the heart and brain, which can be very dangerous because:

• a clot can completely block blood flow, causing a heart attack (myocardial infarction) or stroke, or
• a clot can cause partial blockage of blood vessels leading to the heart, reducing blood flow to the heart and causing chest pain of varying intensity (known as "unstable angina").

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

2. Important information before taking Ticagrelor Olpha

When not to take Ticagrelor Olpha

• if the patient is allergic to ticagrelor or any of the other ingredients of Ticagrelor Olpha (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:
• 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 Ticagrelor Olpha if any of the above situations apply to you. If in doubt, consult a doctor or pharmacist before starting treatment with this medicine.

Warnings and precautions

Before starting treatment with Ticagrelor Olpha, discuss the following with your doctor or pharmacist:

• if the patient has an increased risk of bleeding due to:
• a recent serious injury;
• recent surgery (including dental surgery; consult a dentist);
• a disease that affects blood clotting;
• recent bleeding from the stomach or intestines (such as stomach ulcers or intestinal polyps);
• if the patient is going to have surgery (including dental surgery) while taking Ticagrelor Olpha. This is because of the increased risk of bleeding. The doctor may advise stopping the medicine 5 days before the planned surgery;
• if the patient has a slow heart rate (usually less than 60 beats per minute) and does not have a pacemaker;
• if the patient has asthma or other lung diseases or breathing difficulties;
• if the patient develops breathing difficulties such as rapid breathing, slow breathing, or shortness of breath. The doctor will decide whether further evaluation is needed;
• if the patient has any liver disorders or has had a disease that may have damaged the liver;
• if the patient's blood test shows high levels of uric acid.

Consult a doctor or pharmacist before taking the medicine if any of the above situations apply to you (or if in doubt). If you are taking Ticagrelor Olpha and heparin:

• the doctor may take a blood sample for diagnostic tests if they suspect a rare platelet disorder caused by heparin. It is essential to inform the doctor that you are taking both Ticagrelor Olpha and heparin, as Ticagrelor Olpha may affect the test result.

Children and adolescents

Ticagrelor Olpha is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Ticagrelor Olpha

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. This is necessary because Ticagrelor Olpha may affect the action of other medicines, and other medicines may affect Ticagrelor Olpha. 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 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 inform 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 about taking Ticagrelor Olpha and the 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

Ticagrelor Olpha should not be used during pregnancy or if there is a possibility of becoming pregnant. Women should use appropriate contraceptive measures to avoid becoming pregnant while taking the medicine. Before taking this medicine, inform your doctor if you are breastfeeding. The doctor will discuss the benefits and risks of taking Ticagrelor Olpha while breastfeeding. If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, consult a doctor or pharmacist before taking this medicine.

Driving and using machines

It is unlikely that Ticagrelor Olpha will affect your ability to drive or use machines. If you experience dizziness or disorientation while taking the medicine, be cautious when driving or using machines.

Sodium content

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

3. How to take Ticagrelor Olpha

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

What dose to take

• The usual dose is one 60 mg tablet twice a day. Continue taking Ticagrelor Olpha 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 Ticagrelor Olpha with other blood-thinning medicines

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

How to take Ticagrelor Olpha

The tablets can be taken 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;
• add the powder to half a glass of water;
• mix and drink immediately;
• to ensure that all the medicine is taken, add another half glass of water, rinse, and drink. If you are being treated in a hospital, the tablet can be dissolved in water and given through a nasogastric tube.

What to do if you take more Ticagrelor Olpha than you should

If you take more Ticagrelor Olpha than you should, contact a doctor or go to a hospital immediately. Take the medicine packaging with you. You may experience an increased risk of bleeding.

What to do if you forget to take Ticagrelor Olpha

• 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 want to stop taking Ticagrelor Olpha

Do not stop taking Ticagrelor Olpha without consulting your doctor. Take the medicine regularly and for as long as your doctor recommends. Stopping Ticagrelor Olpha may increase the risk of another heart attack or stroke, or death due to heart or blood vessel disease. If you have any further doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ticagrelor Olpha can cause side effects, although not everybody gets them. The following side effects may occur when taking this medicine: Ticagrelor Olpha affects blood clotting, so 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 into 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 affects only 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 tar);
• 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) - occurs very frequently.It may be caused by heart disease or another cause, or it may be a side effect of Ticagrelor Olpha. Dyspnea associated with Ticagrelor Olpha 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 shortness of breath worsens or persists, consult a doctor. The doctor will decide whether 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 (detected in laboratory tests)
• bleeding caused by blood disorders

Common (may affect up to 1 in 10 people)

• bruising
• headaches
• dizziness or lightheadedness
• diarrhea or indigestion
• nausea (vomiting)
• 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., while shaving) that is more than usual
• stomach bleeding (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 caused by 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 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 side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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 Ticagrelor Olpha

Keep out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister pack and carton after "EXP". The expiry date refers to the last day of the month. There are no special precautions for storage. Store in the original packaging to protect from light. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ticagrelor Olpha contains

• The active substance is ticagrelor. Each coated tablet contains 60 mg of ticagrelor.
• The other ingredients are: Tablet core:hypromellose 2910, mannitol, microcrystalline cellulose, sodium starch glycolate, magnesium stearate Tablet coating:hypromellose 2910, titanium dioxide (E171), macrogol 400, talc, red iron oxide (E172).

What Ticagrelor Olpha looks like and contents of the pack

Coated tablet (tablet): pink, round, biconvex coated tablets with "60" marked on one side and smooth on the other. Blister pack of 14 or 15 coated tablets. Carton containing 56 tablets (4 blister packs), 60 tablets (4 blister packs), 168 tablets (12 blister packs), and 196 tablets (14 blister packs). Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

JSC "Olpha", Rupnicu street 5, Olaine, Olaines district, LV-2114, Latvia. E-mail: [email protected]

Manufacturer:

JSC "Olpha", Rupnicu street 5, Olaine, Olaines district, LV-2114, Latvia. Genepharm S.A, 18th km Marathonos Avenue, 153 51 Pallini Attiki, Greece

Date of last revision of the leaflet: