Tikozek

Package leaflet: Information for the patient

Tikozek 90 mg hard capsules
ticagrelor
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• Speak to your doctor or pharmacist if you have any doubts.
• 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 adverse effects, including any possible side effects 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. What you need to know before you take 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 ticagrelor. It belongs to a group of medicines called 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 or
• unstable angina (chest pain or discomfort that is not adequately controlled).

The medicine reduces the likelihood of having another heart attack or stroke, or of dying from a heart- or blood vessel-related condition.

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 when a blood vessel is cut or damaged.

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 could cause a heart attack (of the heart muscle) 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 (called unstable angina).

Tikozek helps prevent platelets from clumping together, thereby reducing the risk of clot formation that could reduce 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. 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:
  • recent serious injury;
  • recent surgical procedures (including dental procedures – advice from a dentist should be sought in this regard);
  • 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) at any time during treatment with Tikozek. This is due to an increased risk of bleeding. The doctor may recommend 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 apnea. The doctor will decide whether further evaluation is needed;
• if the patient has any liver disorders or has previously had a disease that could have damaged the liver;
• if blood tests have shown high 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 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 reduce cholesterol levels);
• simvastatin or lovastatin at doses higher than 40 mg per day (medicines used to reduce cholesterol levels);
• rifampicin (an antibiotic);
• phenytoin, carbamazepine, and phenobarbital (used to control 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).

Also inform your doctor about taking Tikozek 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
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. Your doctor will discuss the benefits and risks of using Tikozek during breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery
It is unlikely that Tikozek 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.

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 exactly as prescribed by your doctor. If in doubt,
contact 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 administered in hospital.
• After the initial dose, the usual maintenance dose is one 90 mg capsule taken twice daily for up to 12 months, unless your doctor advises otherwise.
• 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 an active
substance found in many medicines used to prevent blood clotting. Your doctor will advise you
on the dose to take (usually between 75 and 150 mg daily).
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 capsule contents may be mixed with water
immediately before administration.
Empty the contents of the capsule into a glass containing a small amount of water, mix thoroughly, and drink immediately after preparation.
If the patient is being treated in hospital, the capsule contents dissolved in water may be
administered via a nasogastric tube (nasogastric feeding tube).
Taking more Tikozek than prescribed
If you take more Tikozek than prescribed, contact your doctor immediately or go to hospital.
Take the medicine pack 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 the 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 first talking to your doctor. You must take the medicine
regularly and for as long as your doctor advises. Stopping Tikozek may increase the risk of
further heart attack or stroke, or death due to heart or blood vessel disease.
If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with this medicine:
Tikozek affects blood clotting, therefore most side effects are related to bleeding. Bleeding may occur anywhere in the body. Some bleeding events are common (e.g. bruising and nosebleeds). Severe bleeding occurs uncommonly, but may be life-threatening.
Contact a doctor immediately if any of the following symptoms occur – urgent medical attention may be required:

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

Discuss with the doctor if the patient experiences:

• shortness of breath (dyspnoea) – very common. It may be caused by heart disease or another condition, or may be a side effect of Tikozek. Dyspnoea associated with Tikozek treatment is usually mild and is characterised by sudden, unexpected breathlessness, typically occurring at rest. It may appear during the first few weeks of treatment and then not occur again for several weeks. If breathlessness worsens or persists for a long time, contact a doctor. The doctor will decide whether treatment or additional tests are necessary.

Other possible side effects
Very common (may affect more than 1 in 10 people)

• increased uric acid levels in blood (detected in laboratory tests)
• bleeding due to blood disorders

Common (may affect up to 1 in 10 people)

• bruising
• headache
• 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 bleed more than usual
• bleeding from gastric mucosa (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)
• visual disturbances due to presence of 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 not known (cannot be estimated from available data)

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

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, talk to your doctor or pharmacist. Side effects 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 side effects helps provide more information on the safe use of the 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 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 90 mg of ticagrelor.
• Other ingredients are:
  Capsule contents: pregelatinized corn starch, 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, filled with white or almost white powder.
PVC/PVDC/Aluminium blisters containing 56 or 60 hard capsules in a cardboard box.
Not all pack sizes may be marketed.

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

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

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