Tigrix

Package leaflet: Information for the user

TIGRIX, 60 mg, film-coated tablets
tikagrelor
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, 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.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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.

What TIGRIX is used for
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 more than one year ago. The medicine reduces the likelihood of having another heart attack or stroke, or of dying due to 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 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 that varies in intensity (called unstable angina).

TIGRIX helps prevent platelets from clumping together, thereby reducing the likelihood of clot formation that could impair 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 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:
  o ketoconazole (used to treat fungal infections);
  o clarithromycin (used to treat bacterial infections);
  o nefazodone (an antidepressant);
  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 – advice should be sought from 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 a planned procedure;
• if the patient has a slow heart rate (usually less than 60 beats per minute) and does not have a cardiac 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 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 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, has recently taken, or 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 simvastatin in doses higher than 40 mg per day or lovastatin (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).

In particular, 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 cimetidine (used to treat heartburn), ergot alkaloids (used to treat migraine and headache); 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-dissolving" 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 should use appropriate contraceptive methods during treatment to avoid pregnancy.
Inform the doctor before using 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 plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
It is unlikely that TIGRIX 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.

3. How to take TIGRIX

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

• The usual dose of this medicine is one 60 mg tablet twice daily. You should continue taking TIGRIX for as long as your doctor recommends.
• 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;
• mix and drink immediately;
• to ensure the entire dose has been 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 dissolving in water.
Instructions for opening the bottle
Press the cap down and turn counterclockwise.
Taking more TIGRIX than recommended
If you take more TIGRIX than recommended, contact your doctor immediately or go to a hospital.
Bring 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
Do not stop taking TIGRIX without talking to your doctor. You should take this medicine regularly
and for as long as your doctor recommends. Stopping TIGRIX 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 may occur at any site in the body. Some bleeding events are common (e.g. bruising and nosebleeds). Severe bleeding is uncommon but may be life-threatening.
Contact a doctor immediately if any of the following symptoms occur

• urgent medical assistance may be required:
• intracranial or brain haemorrhage is an uncommon adverse reaction and may cause stroke-like symptoms such as:
  • sudden numbness or weakness of the 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.
• signs of bleeding such as:
  • heavy or difficult-to-stop bleeding;
  • unexpected bleeding or bleeding lasting a long time;
  • urine that is pink, red or brown;
  • vomiting blood or material that looks like coffee grounds;
  • red or black, tarry stools;
  • coughing or vomiting blood.
• fainting – temporary loss of consciousness caused by a sudden reduction in blood flow to the brain (common).
• symptoms of 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.

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 an adverse reaction to TIGRIX. Dyspnoea associated with TIGRIX is usually mild and is 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 breathlessness worsens or persists for a long time, contact the 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. while shaving) and wounds that bleed more than usual
• bleeding from the stomach 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
• confusion (disorientation)
• visual disturbances caused by 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 not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard box after: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will 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 60 mg of ticagrelor.
• The 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), iron oxide red (E 172), macrogol (E 1521).

What TIGRIX looks like and contents of the pack
Round, biconvex, pink film-coated tablets with a diameter of approximately 8 mm.
TIGRIX is available in blisters made of PVC/PVDC/Aluminium, packed in cardboard boxes containing 56 or 60 film-coated tablets, and in HDPE bottles with a PP 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 countries under the following names:
Croatia: TIGRIX 60 mg filmom obložene tablete
Poland: TIGRIX

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