Tigrix

Package leaflet: Information for the user

TIGRIX, 90 mg, film-coated tablets
tikagrelor
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.
• If you have any further questions, please ask 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 as yours.
• 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 TIGRIX is and what it is used for
2. What you need to know before taking TIGRIX
3. How to take TIGRIX
4. Possible side effects
5. How to store TIGRIX
6. Contents of the pack and other information

1. What TIGRIX is and what it is used for

What TIGRIX is
TIGRIX contains the active substance called tikagrelor. It belongs to a group of medicines known as antiplatelet agents.
Why TIGRIX is used
TIGRIX, in combination with acetylsalicylic acid (another antiplatelet medicine), is used only in adults. You are receiving this medicine because you have had:

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

How TIGRIX works
TIGRIX 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 (myocardial infarction) or stroke, or
• a clot may partially block blood vessels leading to the heart, reducing blood flow to the heart and causing chest pain that varies in intensity (called unstable angina).

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

2. Important information before using TIGRIX

When NOT TO USE TIGRIX

• if the patient is allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6);
• if the patient currently has bleeding;
• if the patient has experienced 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: o ketoconazole (used to treat fungal infections); o clarithromycin (used to treat bacterial infections); o nefazodone (an antidepressant medicine); o ritonavir and atazanavir (used to treat HIV and AIDS infections). Do not take TIGRIX 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 starting to take TIGRIX, discuss this with a doctor or pharmacist:

• if the patient has an increased risk of bleeding due to: o recent serious injury; o recent surgical procedures (including dental procedures – consult a dentist regarding this); o conditions affecting blood clotting; o recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps);
• if the patient will undergo any surgical procedures (including dental procedures) during treatment with TIGRIX. This is due to an increased risk of bleeding. The doctor may advise 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, slowed breathing, or apnoea. The doctor will decide whether further evaluation is needed;
• if the patient has any liver disorders or has previously had a disease that may have damaged the liver;
• if blood tests have shown elevated levels of uric acid. Talk to a doctor or pharmacist before taking TIGRIX if any of the above situations apply (or if in doubt).

If the patient is taking both TIGRIX 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 TIGRIX and heparin, as TIGRIX may affect the diagnostic test result.

Children and adolescents
TIGRIX is not recommended for use in children and adolescents under 18 years of age.
TIGRIX and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This is necessary because TIGRIX may affect the action of other medicines, and other medicines may affect TIGRIX.
Inform the doctor or pharmacist if the patient is taking any of the following medicines:

• rosuvastatin or doses higher than 40 mg per day: simvastatin or lovastatin (medicines used to reduce 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 the doctor or pharmacist if the patient is 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;
• medicines such as cyproheptadine (used to treat heartburn), ergot alkaloids (used to treat migraines and headaches);
• 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). These medicines must not be taken together with TIGRIX (see also: When NOT TO USE TIGRIX).

Fibrinolytic medicines, often called "clot-busting medicines" (such as streptokinase or alteplase), may increase the risk of bleeding if taken together with TIGRIX.
Inform the doctor if the patient is taking TIGRIX.
Pregnancy and breastfeeding
TIGRIX is not recommended during pregnancy or if there is a possibility of becoming pregnant.
Women of childbearing potential should use appropriate contraceptive methods while taking this medicine to avoid pregnancy.
Inform the doctor before taking this medicine if breastfeeding. The doctor will discuss the benefits and risks of using TIGRIX during breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before taking this medicine.
Driving and operating machinery
It is unlikely that TIGRIX impairs the ability to drive or operate machinery. However, if dizziness or disorientation occurs during treatment, caution should be exercised when driving or operating machinery.

3. How to take TIGRIX

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Dosage

• The initial dose is two 90 mg tablets taken at the same time (loading dose of 180 mg). This dose is usually administered in a hospital setting.
• After the initial dose, the usual maintenance dose is one 90 mg tablet taken twice daily for up to 12 months, unless otherwise directed by your doctor.
• It is recommended to take the medicine at the same time each day (e.g. one tablet in the morning and one in the evening).

Taking TIGRIX 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 daily).
How to take TIGRIX

• Tablets may be taken with or without food.

What to do if you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, it may be crushed and mixed with water as follows:

• Crush the tablet into a fine powder;
• Pour the powder into half a glass of water;
• Stir and drink immediately;
• To ensure the entire dose is taken, add another half glass of water, swirl, and drink.

If the patient is being treated in hospital, the tablet may be administered through a nasogastric tube after being dissolved in water.
How to open the bottle
Press the cap down and turn it counterclockwise.
Taking more than the recommended dose of TIGRIX
If you take more than the recommended dose of TIGRIX, 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 TIGRIX

• 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 TIGRIX treatment
Do not stop taking TIGRIX without talking to your doctor. You should take the medicine regularly and for as long as your doctor recommends. Stopping TIGRIX treatment may increase the risk of having another heart attack or stroke, or of dying from a heart or blood vessel-related 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.
TIGRIX affects blood clotting, therefore most adverse reactions are related to bleeding. Bleeding can occur at any site in the body. Some bleeding events are common (e.g. bruising and nosebleeds). Severe bleeding occurs uncommonly, but may be life-threatening.
Contact your doctor immediately if any of the following symptoms occur

• urgent medical attention may be required:
• intracranial haemorrhage 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 with no known cause.

• signs of bleeding such as: heavy or difficult-to-stop bleeding; unexpected bleeding or bleeding lasting a very long time; pink, red or brown urine; vomiting blood or material that looks like coffee grounds; red or black stool (resembling tar); coughing or vomiting blood clots.
• fainting – temporary loss of consciousness caused by a sudden reduction in blood flow to the brain (this 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.

Discuss with the doctor if the patient experiences:

• shortness of breath – this occurs very commonly. It may be caused by heart disease or another condition, or may be an adverse reaction to TIGRIX. Shortness of breath associated with TIGRIX is usually mild and characterised by sudden, unexpected breathlessness, usually at rest, which may occur during the first few weeks of treatment and then may not recur for several weeks. If shortness of breath worsens or persists for a long time, contact your doctor. The 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 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
• severe 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 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
• disorientation (confusion)
• visual disturbances due to presence of blood in the eye
• genital tract 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 (frequency 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store TIGRIX

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the outer carton
after: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What TIGRIX contains

• The active substance is ticagrelor. Each film-coated tablet contains 90 mg of ticagrelor.
• Other ingredients are:
  Tablet core: mannitol, calcium hydrogen phosphate dihydrate, hydroxypropyl cellulose, calcium carmellose, magnesium stearate
  Tablet coating: hypromellose (E 464), titanium dioxide (E 171), talc (E 553b), yellow iron oxide (E 172), macrogol (E 1521)

What TIGRIX looks like and contents of the pack
Round, biconvex, yellow film-coated tablets with a diameter of approximately 9 mm.
TIGRIX is available in PVC/PVDC/Aluminium foil blisters in cardboard boxes containing 56 or 60 film-coated tablets, and in HDPE bottles with a child-resistant closure containing a desiccant, packed in a cardboard box containing 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

This medicinal product is authorised in the European Economic Area member states under the following names:
Croatia: TIGRIX 90 mg filmom obložene tablete
Poland: TIGRIX

For further information, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20