Tigrix

Package Leaflet: Information for the User

TIGRIX, 90 mg, coated tablets

Ticagrelor

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is TIGRIX and what is it used for
• 2. Important information 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 is TIGRIX and what is it used for

What is TIGRIX

TIGRIX contains the active substance ticagrelor, which belongs to a group of antiplatelet medicines.

What is TIGRIX used for

TIGRIX is used in combination with acetylsalicylic acid (another antiplatelet medicine) only in adults. The patient is given this medicine because they have had:

• myocardial infarction or
• unstable angina (chest pain or discomfort that is not adequately controlled). The medicine reduces the likelihood of another myocardial infarction or stroke, or death due to heart or blood vessel disease.

How TIGRIX works

TIGRIX works by affecting cells called platelets (also known as thrombocytes). Platelets are very small blood cells that help stop bleeding by clumping together and blocking small openings in injured blood vessels.

• A blood clot can completely block the blood flow - this can cause a myocardial infarction (heart muscle) or stroke, or
• A blood clot can cause partial blockage of the blood vessels leading to the heart, reducing blood flow to the heart and causing chest pain of varying intensity (known as unstable angina).

TIGRIX helps prevent platelets from clumping together, reducing the likelihood of a blood clot forming, which can reduce blood flow.

2. Important information before taking TIGRIX

When NOT to take TIGRIX

• if the patient is allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6);
• if the patient is currently bleeding;
• if the patient has had a stroke caused by bleeding in 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 TIGRIX if any of the above situations apply to the patient. In case of doubt, consult a doctor or pharmacist before starting treatment with this medicine.

Warnings and precautions

Before starting to take TIGRIX, the patient should discuss the following with their doctor or pharmacist:

• if the patient has an increased risk of bleeding due to: recent serious injury; recent surgery (including dental surgery - the patient should consult their 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) while taking TIGRIX. This is because of the increased risk of bleeding. The doctor may advise stopping TIGRIX 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 that may have damaged the liver;
• if the patient's blood test shows high levels of uric acid. The patient should talk to their doctor or pharmacist before taking TIGRIX if any of the above situations apply to them (or in case of doubt).

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

Children and adolescents

TIGRIX is not recommended for children and adolescents under 18 years of age.

TIGRIX and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take. This is because TIGRIX may affect the way other medicines work, and other medicines may affect TIGRIX.

• rosuvastatin or doses greater than 40 mg per day: simvastatin or lovastatin (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).

In particular, the patient should inform their doctor or pharmacist if they 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;
• medicines such as cisapride (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 notbe taken at the same time as TIGRIX (see also: When NOT to take TIGRIX)

Fibrinolytic medicines, often referred to as "clot-busting" medicines (such as streptokinase or alteplase), may increase the risk of bleeding if taken with TIGRIX. The patient should inform their doctor if they are taking TIGRIX.

Pregnancy and breastfeeding

TIGRIX is not recommended during pregnancy or if the patient is planning to become pregnant. Women should use effective contraception to avoid becoming pregnant while taking TIGRIX. Before taking this medicine, the patient should inform their doctor if they are breastfeeding. The doctor will discuss the benefits and risks of taking TIGRIX while breastfeeding. If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a baby, they should ask their doctor or pharmacist for advice before taking this medicine.

Driving and using machines

It is unlikely that TIGRIX will affect the ability to drive or use machines. If the patient experiences dizziness or disorientation while taking TIGRIX, they should be cautious when driving or using machines.

3. How to take TIGRIX

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.

Dosage

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

Taking TIGRIX with other blood-thinning medicines

The doctor will usually advise taking acetylsalicylic acid at the same time. This is a substance found in many medicines that prevent blood clotting. The doctor will inform the patient about the dose to take (usually between 75 and 150 mg per day).

How to take TIGRIX

• The tablets can be taken with or without food.

What to do if the patient has difficulty swallowing the tablet

If the patient has difficulty swallowing the tablet, it can be crushed and mixed with water as follows:

• crush the tablet into a fine powder;
• add the powder to half a glass of water;
• mix and drink immediately;
• to ensure that all the medicine is taken, add another half glass of water, rinse, and drink.

If the patient is being treated in a hospital, the crushed tablet can be given through a nasogastric tube.

What to do if the patient takes more TIGRIX than they should

If the patient takes more TIGRIX than they should, they should contact their doctor or go to the hospital immediately. They should take the medicine pack with them. There may be an increased risk of bleeding.

What to do if the patient forgets to take TIGRIX

• If the patient forgets to take a dose, they should take the next dose at the usual time.
• The patient should not take a double dose (two doses at the same time) to make up for the forgotten dose.

What to do if the patient stops taking TIGRIX

The patient should not stop taking TIGRIX without talking to their doctor. The medicine should be taken regularly and for as long as the doctor advises. Stopping TIGRIX may increase the risk of another myocardial infarction or stroke, or death due to heart or blood vessel disease. If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, TIGRIX can cause side effects, although not everybody gets them. TIGRIX 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.

The patient should contact their doctor immediately if they experience any of the following symptoms

• may require urgent medical attention:
• bleeding in the brain or within 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 affects only one side of the body; sudden confusion, difficulty speaking or understanding others; sudden difficulty walking, loss of balance, or coordination;

o sudden dizziness or severe headache without a known cause.

• symptoms of bleeding, such as:heavy or prolonged bleeding; unexpected or prolonged bleeding; urine that is pink, red, or brown; vomiting blood or material that looks like coffee grounds; stools that are black or tarry; coughing or vomiting blood clots.
• faintingtemporary loss of consciousness caused by 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 extreme tiredness or confusion.

The patient should discuss the following with their doctor

• shortness of breath (dyspnea) - occurs very frequently. It may be caused by heart disease or another cause, or it may be a side effect of TIGRIX. Dyspnea associated with TIGRIX 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 dyspnea worsens or persists, the patient should contact their doctor. The 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 levels of uric acid 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 nausea
• vomiting
• constipation
• rash
• itching
• increased pain and swelling of the joints - symptoms of gout
• dizziness or lightheadedness - symptoms of low blood pressure
• nosebleeds
• bleeding after surgery or from cuts and wounds (e.g., during shaving) that is more 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)
• vision disturbances caused by blood in the eye
• bleeding from the reproductive tract, which 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

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

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health, via the online reporting system. Side effects can also be reported to the marketing authorization holder.

5. How to store TIGRIX

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TIGRIX contains

• The active substance is ticagrelor. Each coated tablet contains 90 mg of ticagrelor.
• The other ingredients are: Tablet core: mannitol, calcium hydrogen phosphate dihydrate, hydroxypropylcellulose, 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 coated tablets, approximately 9 mm in diameter. TIGRIX is available in blisters of PVC/PVDC/Aluminum in cartons containing 56 or 60 coated tablets, and in HDPE bottles with a PP child-resistant closure containing 100 coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Croatia: TIGRIX 90 mg film-coated tablets; Poland: TIGRIX; For more information, the patient should contact the representative of the marketing authorization holder: Stada Pharm Sp. z o.o., ul. Krakowiaków 44, 02-255 Warsaw, Tel. +48 22 737 79 20

Date of last revision of the leaflet: