Tikozek

PATIENT INFORMATION LEAFLET

Information leaflet included in the packaging: information for the patient

Tikozek, 60 mg, hard capsules

tikagrelor

Read the contents of 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.
• Consult a doctor or pharmacist if you have any doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Tikozek and what is it used for

What is Tikozek

Tikozek contains the active substance tikagrelor. It belongs to a group of medicines called antiplatelet agents.

What is Tikozek used for

Tikozek, in combination with acetylsalicylic acid (another antiplatelet medicine), is used 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 Tikozek works

Tikozek works by affecting cells called platelets (also known as thrombocytes). Platelets are very small blood cells that help stop bleeding by clumping together and sealing 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 the flow of blood - this can cause a heart attack (myocardial infarction) or stroke, or
• a clot can cause partial blockage of blood vessels leading to the heart - which reduces blood flow to the heart and can cause chest pain of varying intensity (known as unstable angina).

Tikozek helps prevent platelets from clumping together, reducing the likelihood of a clot forming that could reduce blood flow.

2. Important information before taking Tikozek

When not to take Tikozek

• if the patient is allergic to tikagrelor or any of the other ingredients of Tikozek (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 Tikozek if any of the above situations apply to you. If in doubt, consult your doctor or pharmacist before starting treatment with this medicine.

Warnings and precautions

Before taking Tikozek, consult 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 your dentist);
• a condition 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) at any time while taking Tikozek. This is because of the increased risk of bleeding. Your doctor may advise stopping Tikozek 5 days before the planned surgery;
• if the patient has a heart rate that is too slow (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 problems or has had a disease that could have damaged the liver;
• if the patient's blood test shows high levels of uric acid. Tell your doctor or pharmacist if any of the above situations apply to you (or if in doubt).

If the patient is taking Tikozek and heparin:

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

Children and adolescents

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

Other medicines and Tikozek

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 Tikozek may affect the action of other medicines, and other medicines may affect Tikozek. 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:

• heparin (see "Warnings and precautions");
• 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 Tikozek 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

Tikozek should not be taken during pregnancy or if there is a possibility of becoming pregnant. Women should use appropriate contraceptive methods 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 Tikozek 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

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

Sodium content

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

3. How to take Tikozek

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

What dose to take

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

Taking Tikozek 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 Tikozek

• The capsules can be taken with or without food.

What to do if you have trouble swallowing the capsules

If you have trouble swallowing the capsules, the contents of the capsule can be mixed with water immediately before taking it. The contents of the capsule should be poured into a glass with a small amount of water, mixed well, and taken immediately after preparation. If the patient is being treated in a hospital, the contents of the capsule can be dissolved in water and given through a nasogastric tube.

What to do if you take more Tikozek than you should

If you take more Tikozek than you should, contact your doctor or go to the hospital immediately. Take the medicine packaging with you. There may be an increased risk of bleeding.

What to do if you forget to take Tikozek

• 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 Tikozek

Do not stop taking Tikozek without talking to your doctor. You should take the medicine regularly and for as long as your doctor recommends. Stopping Tikozek 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 taking Tikozek, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tikozek can cause side effects, although not everybody gets them. The following side effects may occur when taking this medicine: Tikozek 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 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 material that looks like coffee grounds;
• 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 confusion.

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 Tikozek. Dyspnea associated with Tikozek is usually mild and characterized by sudden, unexpected shortness of breath, usually at rest, and 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. 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
• 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 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 can cause dizziness or lightheadedness.

Frequency not known (frequency 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 any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tikozek

Keep out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton after: Expiry date: and on each blister after: EXP. The expiry date refers to the last day of the month stated. Do not store above 30°C. 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 Tikozek contains

• The active substance is tikagrelor. Each hard capsule contains 60 mg of tikagrelor.
• The other ingredients are: Capsule contents: maize starch, mannitol, magnesium stearate. Capsule shell: gelatin, titanium dioxide (E 171), iron oxide yellow (E 172).

What Tikozek looks like and contents of the pack

Tikozek 60 mg hard capsules are size "0", with a white body and a yellow cap, and are filled with a white or almost white powder. PVC/PVDC/Aluminum blisters containing 56 or 60 hard capsules in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder:

Celon Pharma S.A.
ul. Ogrodowa 2A Kiełpin
05-092 Łomianki
tel.: +48 22 75-15-933
e-mail: info@celonpharma.com

Manufacturer:

Celon Pharma S.A.
ul. Marymoncka 15
05-152 Kazuń Nowy
To obtain more detailed information, please contact the local representative of the marketing authorization holder:
Celon Pharma S.A.
ul. Ogrodowa 2A Kiełpin
05-092 Łomianki
tel.: +48 22 75-15-933
e-mail: info@celonpharma.com

Date of last revision of the leaflet: