Ticatrom

Package Leaflet: Information for the Patient

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

1. What is Ticatrom and what is it used for

What is Ticatrom

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

What is Ticatrom used for

Ticatrom is used in combination with acetylsalicylic acid (another antiplatelet medicine) only in adults who 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-related disease.

How Ticatrom works

Ticatrom 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 openings in injured blood vessels.

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

Ticatrom helps prevent platelets from clumping together, reducing the likelihood of a clot forming that could block blood flow.

2. Important information before taking Ticatrom

When not to take Ticatrom

• 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 Ticatrom 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 Ticatrom, consult your doctor or pharmacist:

• 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);

Tell your doctor or pharmacist if any of the above applies to you (or if you are unsure). If you are taking Ticatrom 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 Ticatrom and heparin, as Ticatrom may affect the test result.

Children and adolescents

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

Ticatrom and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. This is necessary because Ticatrom may affect the action of other medicines, and other medicines may affect Ticatrom.

• 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 heart rhythm disorders);
• 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 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), cisapride (used to treat heartburn), and ergot alkaloids (used to treat migraines and headaches).

Also, inform your doctor about taking Ticatrom and the increased risk of bleeding if your doctor prescribes you fibrinolytic medicines, also known as clot-dissolving medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding

Ticatrom should not be taken during pregnancy or if you are planning to become pregnant. While taking the medicine, women should use appropriate contraceptive methods 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 Ticatrom while 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.

Driving and using machines

It is unlikely that Ticatrom will affect your ability to drive or use machines. However, if you experience dizziness or disorientation while taking the medicine, be cautious when driving or operating machines.

Ticatrom contains sodium

Ticatrom contains less than 1 mmol (23 mg) of sodium per tablet, which is considered "sodium-free".

3. How to take Ticatrom

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

What dose to take

• The usual dose is one 60 mg tablet twice a day. Continue taking Ticatrom 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 Ticatrom with other blood-thinning medicines

Your doctor will usually recommend taking acetylsalicylic acid at the same time. This is a substance found in many blood-thinning medicines. Your doctor will inform you about the dose to take (usually between 75 and 150 mg per day).

How to take Ticatrom

• Tablets can be taken with or without food.
• You can check when you last took a tablet by looking at the blister pack. The blister pack has prints showing a sun (for morning doses) and a moon (for evening doses). These prints indicate when you took your last dose.

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;
• pour the powder into half a glass of water;
• mix and drink immediately;
• to ensure you take the entire dose, refill the glass with half a 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 Ticatrom than you should

If you take more Ticatrom than you should, contact your doctor or go to the hospital immediately. Bring the medicine pack with you. You may experience an increased risk of bleeding.

What to do if you forget to take Ticatrom

• If you miss 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 Ticatrom

Do not stop taking Ticatrom without talking to your doctor. You should take the medicine regularly and for as long as your doctor recommends. Stopping Ticatrom may increase the risk of having another heart attack or stroke, or dying from a heart or blood vessel-related disease.

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

4. Possible side effects

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

The following side effects may occur while taking this medicine:

Ticatrom 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 immediate medical attention if you experience any of the following symptoms - you may need 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;
• sudden dizziness or severe headache without a 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 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 Ticatrom. Dyspnea associated with Ticatrom 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 shortness of breath 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 (detected 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;
• disorientation (confusion);
• vision disturbances due to blood in the eye;
• vaginal 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 (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 leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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 Ticatrom

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

The notation on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.

There are no special storage instructions for this medicine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ticatrom contains

• The active substance is ticagrelor. Each coated tablet contains 60 mg of ticagrelor.
• The other ingredients are: Core: mannitol (E421), calcium hydrogen phosphate dihydrate, hypromellose 2910 (5 mPa·s), sodium carboxymethylcellulose (type A), magnesium stearate. Coating: hypromellose 2910 (6 mPa·s), titanium dioxide (E171), talc, macrogol 8000, iron oxide red (E172).

What Ticatrom looks like and contents of the pack

Ticatrom is a pink, round, biconvex tablet with a symbol "60" engraved on one side, with a diameter of 7.9-8.4 mm.

The medicine is packaged in PVC/PVDC/Aluminum blister packs in a cardboard box.

Available pack sizes: 14, 56, 60, 168, 180 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Date of last revision of the leaflet: