Tiscard

Package Leaflet: Information for the Patient

Tiscard, 90 mg, Film-Coated Tablets

Ticagrelor

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

• Keep this package 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 package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Tiscard and what is it used for
• 2. Important information before taking Tiscard
• 3. How to take Tiscard
• 4. Possible side effects
• 5. How to store Tiscard
• 6. Contents of the pack and other information

1. What is Tiscard and what is it used for

What is Tiscard

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

What is Tiscard used for

Tiscard is used in combination with acetylsalicylic acid (another antiplatelet medicine) only in adults who have had:

• heart attack or
• unstable angina (chest pain or discomfort which is not well controlled).

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

How Tiscard works

Tiscard works by affecting platelets in the blood. Platelets are very small blood cells that help stop bleeding by clumping together and blocking small openings in blood vessels.

However, platelets can also clump together and form clots in narrowed blood vessels in the heart and brain, which can be very dangerous because:

• a clot can completely block the blood flow, which can cause a heart attack (heart muscle damage) or stroke, or
• a clot can partially block the blood vessels leading to the heart, which reduces blood flow to the heart and can cause chest pain (unstable angina).

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

2. Important information before taking Tiscard

When not to take Tiscard

• if you are allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6);
• if you have active 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:
• ketokonazole (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 Tiscard 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 Tiscard, tell 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 having surgery (including dental surgery) while taking Tiscard. This is because of an increased risk of bleeding. Your doctor may advise you to stop taking Tiscard 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 if 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.

Tell your doctor or pharmacist if any of the above applies to you (or if in doubt).

If you are taking Tiscard and heparin:

• your doctor may take a blood sample for diagnostic tests if they suspect a rare platelet disorder caused by heparin. It is important to inform your doctor that you are taking both Tiscard and heparin, as Tiscard may affect the test result.

Children and adolescents

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

Tiscard with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and any you plan to take.

This is necessary because Tiscard may affect the way other medicines work, and other medicines may affect Tiscard.

Tell your doctor or pharmacist if you are taking any of the following medicines:

• rosuvastatin (a medicine used to lower cholesterol levels);
• simvastatin or lovastatin in doses greater than 40 mg per day (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 irregular heart rhythms);
• beta-blockers and verapamil (used to treat high blood pressure);
• morphine and other opioids (used to treat severe pain).

Especially tell 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;
• other medicines, such as ketokonazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (used to treat HIV and AIDS infections), cisapride (used to treat heartburn), and ergot alkaloids (used to treat migraines and headaches).

Also, tell your doctor if you are taking Tiscard and have an increased risk of bleeding if your doctor prescribes you fibrinolytic medicines, often referred to as "clot-busting" medicines, such as streptokinase or alteplase.

Tiscard with food

The tablets can be taken with or without food.

Pregnancy and breastfeeding

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

Tiscard should not be taken during pregnancy or if you are planning to become pregnant. During treatment with Tiscard, women should use appropriate contraceptive methods to prevent pregnancy.

Before taking this medicine, tell your doctor if you are breastfeeding. Your doctor will discuss the benefits and risks of taking Tiscard during breastfeeding.

Driving and using machines

It is unlikely that Tiscard will affect your ability to drive or use machines. If you experience dizziness or confusion while taking this medicine, be careful when driving or using machines.

Tiscard contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Tiscard

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

How much to take

• The starting dose is two tablets taken at the same time (a loading dose of 180 mg). This dose is usually given in a hospital.
• After the starting dose, the usual dose is one 90 mg tablet twice a day for up to 12 months, unless your doctor tells you 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 Tiscard with other anti-clotting 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 tell you what dose to take (usually between 75 and 150 mg per day).

How to take Tiscard

The tablets can be taken with or without food.

What to do if you have trouble swallowing the tablet

If you have trouble 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 make sure you take all the medicine, add another half glass of water, rinse, and drink.

If you are in the hospital, the crushed tablet can be given through a nasogastric tube.

What to do if you take more Tiscard than you should

If you take more Tiscard than you should, contact your doctor or go to the hospital immediately. Bring the medicine pack with you. You may be at risk of bleeding.

What to do if you forget to take Tiscard

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 the missed dose.

What to do if you stop taking Tiscard

Do not stop taking Tiscard without consulting your doctor. You should take the medicine regularly and for as long as your doctor tells you. Stopping Tiscard may increase the risk of having another heart attack or stroke, or dying from a heart or blood vessel-related problem.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

The following side effects may occur while taking this medicine.

Tiscard affects blood clotting, so most side effects are related to bleeding. Bleeding can occur anywhere in the body. Some bleeding is common (e.g., bruising and nosebleeds). Severe bleeding is less common but can be life-threatening.

Seek medical help immediately if you experience any of the following symptoms - you may need 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, trouble speaking or understanding;
• sudden trouble walking, loss of balance or coordination;
• sudden dizziness or severe headache with no known cause;
• Bleeding symptoms, such as:
• heavy or prolonged bleeding;
• unexpected or prolonged bleeding;
• urine that is pink, red, or brown;
• vomiting blood or coffee ground-like material;
• stool that is red or black (like tar);
• coughing or vomiting blood clots;
• Fainting
• temporary 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 extreme tiredness or confusion.

Tell your doctor if you experience:

• Shortness of breath (dyspnea) - occurs "very commonly". It may be caused by heart disease or another cause, or it may be a side effect of Tiscard. Dyspnea related to Tiscard 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 if 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 (feeling sick);
• constipation;
• rash;
• itching;
• increased pain and swelling of the joints - symptoms of gout;
• dizziness or lightheadedness, or blurred vision - 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 (stomach 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;
• vaginal bleeding that is heavier or occurs at an unusual time (e.g., between menstrual periods);
• bleeding into the 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 the available data)

• 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 package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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

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 Tiscard

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 carton after "EXP". The expiry date refers to the last day of that month.

PVC/PVDC/Aluminium blisters:

Do not store above 30°C. Store in the original package to protect from light.

PVC/PE/PVDC/Aluminium blisters:

No special storage precautions are required. Store in the original package to protect from light.

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 Tiscard contains

• The active substance is ticagrelor. Each film-coated tablet contains 90 mg of ticagrelor.
• The other ingredients are: tablet core: hypromellose 2910, mannitol (E 421), microcrystalline cellulose, sodium carboxymethylcellulose (type A), magnesium stearate. tablet coating: hypromellose 2910, titanium dioxide (E 171), macrogol 400, talc, yellow iron oxide (E 172).

What Tiscard looks like and contents of the pack

Tiscard is a yellow, round, biconvex film-coated tablet, 9.1 mm in diameter, with "90" engraved on one side and a smooth surface on the other.

The pack contains blisters of PVC/PVDC/Aluminium or PVC/PE/PVDC/Aluminium.

One pack contains 56 tablets in a carton.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.

ul. Partyzancka 133/151

95-200 Pabianice

Tel. +48 42 22-53-100

Manufacturer

Genapharm S.A.

18 km Marathonos Avenue

15351 Pallini Attiki

Greece

Date of last revision of the package leaflet: