Tikozek

PATIENT INFORMATION LEAFLET

Information leaflet attached to the packaging: patient information

Tikozek 90 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

What is Tikozek

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

What Tikozek is used for

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

• heart attack or
• unstable angina (chest pain or angina that is not adequately controlled). The medicine reduces the likelihood of having another heart attack or stroke or dying from a heart or blood vessel-related disease.

How Tikozek works

Tikozek works by affecting cells called platelets in the blood (also called thrombocytes). Platelets are very small blood cells that help stop bleeding by clumping together and blocking small holes in damaged blood vessels.

• a blood clot can completely block the blood flow - this can cause a heart attack (of the heart muscle) or stroke or:
• a blood clot can cause partial blockage of the blood vessels leading to the heart - this reduces blood flow to the heart and can cause chest pain of varying intensity (called unstable angina). Tikozek helps prevent platelets from clumping together, reducing the likelihood of a blood 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:
• ketokonazol (used to treat fungal infections);
• klarytromycyna (used to treat bacterial infections);
• nefazodon (an antidepressant);
• rytonawir and atazanawir (used to treat HIV and AIDS infections) Do not take Tikozek 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 Tikozek, consult a doctor or pharmacist:

• if the patient has an increased risk of bleeding due to:
• recent serious injury;
• recent surgery (including dental surgery - consult a 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. The doctor may advise stopping the medicine 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 in the past 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 applies 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 essential to inform the doctor about taking both Tikozek and heparin, as Tikozek may affect the test result.

Children and adolescents

Tikozek should not be used in 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.

• rosuwastatin (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 ketokonazol (used to treat fungal infections), klarytromycyna (used to treat bacterial infections), nefazodon (an antidepressant), rytonawir and atazanawir (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 Tikozek 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

Tikozek should not be used 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.

Your 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 cautious 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 initial dose is two capsules taken at the same time (loading dose of 180 mg). This dose is usually given in a hospital.
• After the initial dose, the usual dose is one 90 mg capsule taken 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 capsule in the morning and one in the evening).

Taking Tikozek with other blood-thinning medicines

Your doctor will usually advise you to take 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 difficulty swallowing the capsules

If you have difficulty swallowing the capsules, the contents of the capsule can be mixed with water immediately before taking it.

Empty the contents of the capsule into a glass with a small amount of water, mix thoroughly, and drink immediately after preparation.

If you are 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 a doctor or go to a hospital immediately.

Take the medicine packaging with you.

You may be at 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.

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

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

If you have any further questions on the use of this product, ask 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 while taking this medicine:

Tikozek 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 inside 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;
• symptoms of bleeding, such as:
• heavy bleeding or bleeding that is difficult to stop;
• unexpected bleeding or bleeding that lasts a long time;
• 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 severe fatigue or confusion.

Tell your doctor if you experience:

• shortness of breath (dyspnea) - occurs very commonly.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, 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 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 (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 - 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 (stomach 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 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 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 any possible 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:

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 90 mg of tikagrelor.
• The other ingredients are: Capsule contents: cornstarch, mannitol, magnesium stearate. Capsule shell: gelatin, titanium dioxide (E 171), iron oxide, red (E 172).

What Tikozek looks like and contents of the pack

Tikozek 90 mg hard capsules are size 0, with a white body and an orange to red 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

For more information, contact your 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: