Tikozek

Patient Information Leaflet

Tikozek, 60 mg, hard capsules
ticagrelor
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Tikozek is and what it is 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 Tikozek is and what it is used for

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

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

• a heart attack more than one year ago. The medicine reduces the likelihood of having another heart attack or stroke, or death due to heart or blood vessel disease.

How Tikozek works
Tikozek 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 may cause a heart attack (myocardial infarction) or stroke, or
• a clot may cause partial blockage of blood vessels leading to the heart – reducing blood flow to the heart and possibly causing chest pain of varying intensity (called unstable angina).

Tikozek helps prevent platelets from clumping together, thereby reducing the risk of clot formation that could impair blood flow.

2. Important information before using Tikozek

When not to use Tikozek

• if the patient is allergic to ticagrelor 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:
  • 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 Tikozek 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 Tikozek, 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 is scheduled to undergo any surgical procedure (including dental) during treatment with Tikozek. This is due to an increased risk of bleeding. The doctor may recommend discontinuing 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 apnea. The doctor will decide whether further evaluation is needed;
• if the patient has any liver disorders or has previously had a condition that could have damaged the liver;
• if blood tests have shown elevated levels of uric acid in the patient. Talk to a doctor or pharmacist before taking Tikozek if any of the above situations apply (or if in doubt).

If the patient is taking both Tikozek and heparin:

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

Children and adolescents
Tikozek is not recommended for use 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, have recently taken, or 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 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:

• heparin (see section "Warnings and precautions");
• oral anticoagulants, often called blood thinners, 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), cisapride (used to treat heartburn), ergot alkaloids (used to treat migraines and headaches).

You should also inform your doctor about taking Tikozek and the increased risk of bleeding if your doctor prescribes fibrinolytic medicines, often called clot-dissolving agents, such as streptokinase or alteplase.
Pregnancy and breastfeeding
Tikozek is not recommended during pregnancy or if there is a possibility of becoming pregnant.
Women should use appropriate contraceptive methods while taking this medicine to avoid pregnancy.
Inform your doctor if you are breastfeeding. The doctor will discuss the benefits and risks of using Tikozek during breastfeeding.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Driving and using machines
It is unlikely that Tikozek affects the ability to drive or operate machinery. However, if dizziness or disorientation occurs during treatment, exercise caution when driving or operating machinery.
Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Tikozek

This medicine should always be taken as directed by your doctor. If you have any doubts,
contact your doctor or pharmacist.
What dose to take

• The usual dose is one 60 mg capsule twice daily. You should continue taking Tikozek for as long as your doctor recommends.
• It is recommended to take the medicine at the same time each 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 advise you on the dose to take
(usually between 75 and 150 mg per day).
How to take Tikozek

• Capsules may be taken with or without food.

What to do if you have difficulty swallowing capsules
If you have difficulty swallowing the capsules, the contents of the capsule may be mixed with water
immediately before taking.
Empty the contents of the capsule into a glass containing a small amount of water, stir well and
drink immediately after preparation.
If the patient is being treated in hospital, the contents of the capsule may be administered through
a nasal tube (nasogastric tube) after dissolving in water.
Taking more Tikozek than recommended
If you take more Tikozek than recommended, contact your doctor immediately or go to hospital.
Take the medicine packaging with you.
There may be an increased risk of bleeding.
If you miss a dose of Tikozek

• 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 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during treatment with this medicine:
Tikozek affects blood clotting, therefore most adverse reactions are related to bleeding. Bleeding may occur anywhere in the body. Some bleeding events are common (e.g. bruising and nosebleeds). Severe bleeding occurs less frequently but may be life-threatening.
You should contact your doctor immediately if any of the following symptoms occur – urgent medical attention may be required:

• Intracranial bleeding or bleeding into the brain is an uncommon adverse reaction and may cause stroke-like symptoms such as:
• sudden numbness or weakness of the 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 without known cause;
  • Symptoms of bleeding such as:
• heavy or difficult-to-stop bleeding;
• unexpected bleeding or bleeding lasting a long time;
• urine discolored pink, red or brown;
• vomiting blood or material that looks like coffee grounds;
• stool discolored 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 (this is common).
  • Symptoms related to a blood clotting disorder called thrombotic thrombocytopenic purpura (TTP), such as:
• fever and purple skin spots (called purpura) on the skin or inside the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained extreme fatigue or confusion.

You should discuss with your doctor if the patient experiences:

• Shortness of breath (dyspnea) – very common. It may be caused by heart disease or another condition, or it may be an adverse reaction to Tikozek. Dyspnea associated with Tikozek treatment is usually mild and characterized by sudden, unexpected breathlessness, usually occurring at rest, which 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. Your doctor will decide whether treatment or further investigations are needed.

Other possible adverse reactions
Very common (may affect more than 1 in 10 people)

• increased blood uric acid levels (detected in laboratory tests)
• bleeding caused by blood disorders

Common (may affect up to 1 in 10 people)

• bruising
• headache
• dizziness or vertigo
• diarrhoea or indigestion
• nausea (feeling sick)
• 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 minor cuts (e.g. while 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
• confusion
• visual disturbances caused by blood in the eye
• vaginal bleeding that is heavier 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 unknown (cannot be estimated from available data)

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, consult your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Tikozek

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box following:
Expiry date and on each blister after: EXP. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines must 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 package and other information

What Tikozek contains

• The active substance is ticagrelor. Each hard capsule contains 60 mg of ticagrelor.
• The other ingredients are:
  Capsule contents: pregelatinized corn 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 yellow cap, filled with white or almost white powder.
Packs of 56 or 60 hard capsules in PVC/PVDC/Aluminium blisters, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Celon Pharma S.A.
ul. Ogrodowa 2A Kiełpin
05-092 Łomianki
tel.: +48 22 75-15-933
e-mail: [email protected]

Manufacturer:
Celon Pharma S.A.
ul. Marymoncka 15
05-152 Kazuń Nowy

For further information, please contact the local representative of the Marketing Authorisation Holder:
Celon Pharma S.A.
ul. Ogrodowa 2A Kiełpin
05-092 Łomianki
tel.: +48 22 75-15-933
e-mail: [email protected]