Tiscard

Package leaflet: Information for the patient

Tiscard, 90 mg, film-coated tablets
Ticagrelor
Please read all of this leaflet carefully before taking this medicine, because 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 other people, 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 Tiscard is and what it is 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 Tiscard is and what it is used for

What Tiscard is
Tiscard contains an active substance called ticagrelor. It belongs to a group of medicines known as antiplatelet agents.

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

• a heart attack or
• unstable angina (chest pain or discomfort that is not adequately controlled).

The medicine reduces the likelihood of having another heart attack or stroke, or of dying due to heart or blood vessel disease.

How Tiscard works
Tiscard affects 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 cuts or damaged blood vessels.

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 causing chest pain that varies in intensity (known as unstable angina).

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

2. Important information before taking Tiscard

When not to take Tiscard

• 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:
• ketoconazole (used to treat fungal infections);
• clarithromycin (used to treat bacterial infections);
• nefazodone (an antidepressant);
• ritonavir and atazanawir (used to treat HIV and AIDS infections).

Do not take Tiscard 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 taking Tiscard, consult a doctor or pharmacist:

• if the patient has an increased risk of bleeding due to:
• recent serious injury;
• recent surgical procedures (including dental procedures – consult a dentist regarding this);
• a medical condition affecting blood clotting;
• recent gastrointestinal bleeding (such as: stomach ulcer or intestinal polyps);
• if the patient will undergo surgical procedures (including dental procedures) at any time during treatment with Tiscard. 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 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 apnea. The doctor will decide whether further evaluation is necessary;
• if the patient has any liver disorders or has previously had a disease 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 this medicine if any of the above situations apply to the patient (or if in doubt).

If the patient is taking both Tiscard 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 Tiscard and heparine, as Tiscard may affect the diagnostic test result.

Children and adolescents

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

Tiscard and other medicines

Tell your 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 Tiscard may affect the action of other medicines, and other medicines may affect Tiscard.

Inform the doctor or pharmacist if the patient is taking any of the following medicines:

• rosuvastatin (a medicine used to reduce cholesterol levels);
• simvastatin or lovastatin at doses higher than 40 mg per day (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 thinners", 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;
• 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), cimetidine (used to treat heartburn), ergot alkaloids (used to treat migraines and headaches).

Also inform the doctor about taking Tiscard and the increased risk of bleeding if the doctor prescribes fibrinolytic medicines, often called "clot-dissolving" medicines, such as: streptokinase or alteplase.

Tiscard with food

Tablets can be taken with or without food.

Pregnancy and 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.

Tiscard is not recommended during pregnancy or if there is a possibility of becoming pregnant. Women should use appropriate contraceptive methods while taking this medicine to avoid becoming pregnant.

Before taking this medicine, inform the doctor if breastfeeding. The doctor will discuss the benefits and risks associated with taking Tiscard during breastfeeding.

Driving and operating machinery

It is unlikely that Tiscard 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.

Sodium content

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Tiscard

This medicine should always be taken as directed by the physician. If in doubt,
contact the physician or pharmacist.
What dose to take

• The initial dose is two tablets taken at the same time (loading dose 180 mg). This dose is usually administered in hospital.
• 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 the physician.
• 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 Tiscard with other blood-thinning medicines
The physician will usually recommend taking acetylsalicylic acid concomitantly. This is a substance
present in many medicines that prevent blood clotting. The physician will advise on the dose to be taken
(usually between 75 and 150 mg daily).
How to take Tiscard
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 is consumed, add another half glass of water to the container, swirl and drink.

If the patient is being treated in hospital, the tablet may be administered via a nasogastric tube after being dissolved in water.
If you take more Tiscard than you should
If you take more than the recommended dose of Tiscard, contact your physician immediately or go to the hospital.
Bring the medicine packaging with you. There may be an increased risk of bleeding.
If you miss a dose of Tiscard
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 Tiscard treatment
Do not stop taking Tiscard without consulting your physician. The medicine should be taken regularly and for as long as directed by the physician. Stopping treatment with Tiscard may increase the risk of recurrent heart attack or stroke, or death due to heart or blood vessel disease.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur during treatment with this medicine.
Tiscard affects blood clotting, therefore most adverse reactions are related to bleeding. Bleeding may occur anywhere in the body. Some bleeding events are common (e.g. bruising and nosebleeds). Severe bleeding occurs less frequently, but may be life-threatening.
You should contact your doctor immediately if any of the following symptoms occur – urgent medical help may be needed:

• bleeding into the brain or intracranial 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 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;
• symptoms of bleeding such as:
• heavy bleeding or bleeding that is difficult to stop;
• unexpected bleeding or bleeding that lasts a long time;
• urine that is pink, red or brown;
• vomiting blood or material that looks like coffee grounds;
• stools that are red or black (resembling tar);
• coughing up or vomiting blood clots;
• fainting;
• temporary loss of consciousness caused by a sudden reduction 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 fatigue or disorientation.

You should discuss with your doctor if the patient experiences:

• shortness of breath – occurs "very commonly". It may be caused by heart disease or another condition, or may be an adverse reaction to Tiscard. Shortness of breath associated with Tiscard treatment is usually mild and characterised by sudden, unexpected breathlessness, usually occurring at rest. It may appear during the first few weeks of treatment and then not recur for several weeks. If shortness of breath worsens or persists for a long time, contact your doctor. Your 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 uric acid levels in blood (detected in laboratory tests);
• bleeding caused by blood disorders.

Common (may affect up to 1 in 10 people)

• bruising;
• headaches;
• dizziness or vertigo;
• diarrhoea or indigestion;
• nausea;
• constipation;
• rash;
• itching;
• increased 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 caused by blood in the eye;
• vaginal bleeding that is heavier than usual 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 of Monitoring Adverse Drug Reactions of the 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
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 the medicine Tiscard

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard
package following the abbreviation EXP. The expiry date refers to the last day of the
specified month.
PVC/PVDC/Aluminium blisters:
Do not store above 30°C. Keep in the original packaging to protect from light.
PVC/PE/PVDC/Aluminium blisters:
No special storage conditions required. Keep in the original packaging 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 in use. This will help protect
the environment.

6. Contents of the pack and other information

What Tiscard contains

• The active substance in Tiscard is ticagrelor. Each coated tablet contains 90 mg of ticagrelor.
• The other ingredients are: Tablet core: hypromellose 2910, mannitol (E 421), microcrystalline cellulose, sodium carboxymethyl starch (type A), magnesium stearate. Tablet coating: hypromellose 2910, titanium dioxide (E 171), polyethylene glycol 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 with a diameter of 9.1 mm, marked with "90" on one side and smooth on the other.
Tiscard is packed in blisters made of PVC/PVDC/Aluminium or PVC/PE/PVDC/Aluminium.
One pack contains 56 tablets in a cardboard box.
Marketing Authorisation 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