Tigrix

Package Leaflet: Information for the User

TIGRIX, 60 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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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. You have been given this medicine because you have had:

• a heart attack, more than a year ago. The medicine reduces the likelihood of having another heart attack or stroke, or dying from a heart or blood vessel disease.

How TIGRIX works

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

• However, platelets can also form clots inside diseased blood vessels in the heart and brain, which can be very dangerous, as:
• a clot can completely block the flow of blood, which can cause a heart attack (myocardial infarction) or stroke, or
• a clot can cause partial blockage of blood vessels leading to the heart, reducing blood flow to the heart and causing chest pain (unstable angina).

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

2. Important information before taking TIGRIX

When NOT to take TIGRIX

• if you are allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6);
• if you are currently bleeding;
• if you have had a stroke caused by bleeding in the brain;
• if you have severe liver disease;
• if you are 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 applies to you. If in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking TIGRIX, discuss with your doctor or pharmacist:

• if you have an increased risk of bleeding due to: recent serious injury; recent surgery (including dental surgery - consult your dentist); a condition that affects blood clotting; recent bleeding from the stomach or intestines (such as stomach ulcers or intestinal polyps);
• if you will be undergoing surgery (including dental surgery) while taking TIGRIX. This is because of the increased risk of bleeding. Your doctor may advise you to stop taking TIGRIX 5 days before the planned surgery;
• if you have a slow heart rate (usually less than 60 beats per minute) and do not have a pacemaker;
• if you have asthma or other lung diseases or breathing difficulties;
• if you develop breathing difficulties such as rapid breathing, slow breathing, or shortness of breath. Your doctor will decide whether further evaluation is needed;
• if you have any liver problems or have had a disease that may have damaged your liver;
• if your blood test shows high levels of uric acid. Inform your doctor or pharmacist before taking TIGRIX if any of the above applies to you (or if in doubt).

If you are taking TIGRIX and heparin:

• Your doctor may take a blood sample for diagnostic tests if they suspect a rare platelet disorder caused by heparin. It is essential to inform your doctor that you are 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. This is necessary because TIGRIX may affect the way other medicines work, and other medicines may affect TIGRIX.

• rosuvastatin or at 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, inform your doctor or pharmacist if you 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-dissolving medicines (such as streptokinase or alteplase), may increase the risk of bleeding if taken with TIGRIX.

Pregnancy and breastfeeding

TIGRIX should not be taken during pregnancy or if you are planning to become pregnant.

While taking TIGRIX, women should use effective contraception to avoid becoming pregnant.

Before taking this medicine, inform your doctor if you are breastfeeding.

Your doctor will discuss the benefits and risks of taking TIGRIX while breastfeeding.

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

It is unlikely that TIGRIX will affect your ability to drive or use machines.

If you experience dizziness or confusion while taking TIGRIX, be careful when driving or using machines.

3. How to take TIGRIX

Always take this medicine exactly as your doctor has told you.

Dosage

• The usual dose is one 60 mg tablet twice a day. Continue taking TIGRIX for as long as your doctor recommends.
• 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

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 inform you 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 you have difficulty swallowing the tablet

If you have difficulty swallowing the tablet, you can crush it and mix it 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 you are being treated in a hospital, the crushed tablet can be given through a nasogastric tube.

Instructions for opening the bottle

Press the cap down and turn it counterclockwise.

What to do if you take more TIGRIX than you should

If you take more TIGRIX than you should, contact your doctor or go to the hospital immediately.

Take the medicine pack with you.

There may be an increased risk of bleeding.

What to do if you forget to take TIGRIX

• If you forget to take 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 forgotten dose.

What to do if you stop taking TIGRIX

Do not stop taking TIGRIX without talking to your doctor.

Take the medicine regularly and for as long as your doctor recommends.

Stopping TIGRIX may increase the risk of having another heart attack or stroke, or dying from a heart or blood vessel disease.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

TIGRIX affects blood clotting, and 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.

Seek medical help immediately if you experience any of the following symptoms

• may require urgent medical attention:
• bleeding in the brain or inside 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 occurs on one side of the body; sudden confusion, difficulty speaking or understanding others; sudden difficulty walking, loss of balance, or coordination; 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 coffee-ground-like material; stools that are black or tarry; coughing or vomiting blood clots.
• faintingtemporary loss of consciousness due to 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 severe fatigue or confusion.

Tell your doctor if you experience:

• 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, contact your doctor. Your 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 uric acid levels 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 indigestion
• 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 that is more than usual
• stomach bleeding (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)
• vision disturbances due to 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 you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Jerozolimskie Avenue 181C

02-222 Warsaw

Phone: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help 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 pack and carton after EXP.

The expiry date refers to the last day of the month stated.

No special precautions for storage are necessary.

Medicines should 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 pack and other information

What TIGRIX contains

• The active substance is ticagrelor. Each 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 coated tablets, approximately 8 mm in diameter.

TIGRIX is available in PVC/PVDC/Aluminum blister packs in cartons containing 56 or 60 coated tablets, and in HDPE bottles with a PP cap, containing a desiccant, in cartons 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 60 mg film-coated tablets

Poland:

TIGRIX

For more information, contact the representative of the marketing authorization holder:

Stada Pharm Sp. z o.o.

Krakowiaków 44

02-255 Warsaw

Phone: +48 22 737 79 20

Date of last revision of the leaflet: