Ticatrom

Patient Information Leaflet

Ticatrom, 60 mg, coated tablets
Ticagrelor
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Ticatrom is and what it is 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 Ticatrom is and what it is used for

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

What Ticatrom is used for
Ticatrom, in combination with acetylsalicylic acid (another antiplatelet medicine), is used only in adults who have previously had a heart attack more than one year ago. Ticatrom reduces the risk of another heart attack or stroke, or death due to heart- or blood vessel-related disease.

How Ticatrom works
Ticatrom affects blood cells called platelets (also known as thrombocytes). Platelets are very small blood cells that help stop bleeding by clumping together and sealing small openings when a blood vessel is cut or damaged.

However, platelets can also form clots inside blood vessels that are already diseased, in the heart and brain. This can be very dangerous because:

• A clot may completely block blood flow – which can lead to 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 possibly causing chest pain that varies in intensity (known as unstable angina).

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

2. Information before using Ticatrom

When not to use Ticatrom

• if the patient is allergic to ticagrelor or any of the other ingredients of the medicine (listed in section 6);
• if the patient is currently bleeding;
• if the patient has experienced a haemorrhagic stroke (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 atazanavir (used to treat HIV and AIDS infections).

Do not take Ticatrom if any of the above situations apply. If in doubt, consult a doctor or pharmacist before starting treatment with this medicine.

Warnings and precautions
Before taking Ticatrom, 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 about this);
  • a condition affecting blood clotting;
  • recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps);
• if the patient will undergo any surgical procedures (including dental procedures) while taking Ticatrom. 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, slow breathing, or apnoea. The doctor will decide whether further evaluation is needed;
• if the patient has any liver disorders or has previously had a condition that may 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 Ticatrom if any of the above situations apply (or if in doubt).
If the patient is taking both Ticatrom 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 Ticatrom and heparin, as Ticatrom may affect the diagnostic test result.

Children and adolescents
Ticatrom is not recommended for use in children and adolescents under 18 years of age.
Ticatrom with other medicines
Tell the doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken. This is necessary because Ticatrom may affect the action of other medicines, and other medicines may affect Ticatrom.
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 in doses higher than 40 mg daily (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).

In particular, 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-thinning medicines, 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), cyproheptadine (used to treat heartburn), ergot alkaloids (used to treat migraines and headaches).

Also inform the doctor about taking Ticatrom and the increased risk of bleeding if the doctor prescribes fibrinolytic medicines, often called clot-dissolving medicines, such as streptokinase or alteplase.
Pregnancy and breastfeeding
Ticatrom is not recommended during pregnancy or if there is a possibility of becoming pregnant.
Women of childbearing potential should use appropriate contraceptive methods while taking this medicine to avoid pregnancy.
Inform the doctor if breastfeeding. The doctor will discuss the benefits and risks of using Ticatrom during 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 using this medicine.
Driving and operating machinery
It is unlikely that Ticatrom will impair the ability to drive or operate machinery. However, if dizziness or confusion occurs while taking the medicine, caution should be exercised when driving or operating machinery.
Ticatrom contains sodium
Ticatrom contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Ticatrom
Always take this medicine exactly as prescribed by the doctor. If in doubt, contact the doctor or pharmacist.
How much medicine to take

• The usual dose is one 60 mg tablet twice daily. Continue taking Ticatrom for as long as recommended by the doctor.
• 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 Ticatrom with other blood-thinning medicines
The doctor will usually recommend taking acetylsalicylic acid (aspirin) at the same time. This is a substance present in many medicines used to prevent blood clotting. The doctor will advise on the dose to take (usually between 75 and 150 mg daily).
How to take Ticatrom

• Tablets may be taken with or without food.
• The patient can check when the last tablet was taken by looking at the blister pack. The blister contains printed symbols indicating the sun (for morning doses) and the moon (for evening doses). These symbols help patients remember when they last took a dose.

What to do if having difficulty swallowing the tablet
If the patient has 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 taken, add another half glass of water, swirl, and drink. If the patient is being treated in hospital, the crushed tablet mixed with water may be administered via a nasogastric tube.

Taking more Ticatrom than recommended
If more Ticatrom is taken than recommended, contact a doctor or go to a hospital immediately. Bring the medicine packaging with you. There may be an increased risk of bleeding.
If a dose is missed

• If a dose is missed, 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 missed dose.

Stopping Ticatrom
Do not stop taking Ticatrom without talking to a doctor. The medicine should be taken regularly and for as long as prescribed. Stopping Ticatrom may increase the risk of recurrent heart attack or stroke, or death due to heart or blood vessel disease.
If there are any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
The following adverse effects may occur during treatment with this medicine:
Ticatrom affects blood clotting, therefore most adverse effects are related to bleeding. Bleeding can occur anywhere in the body. Some bleeding events are common (e.g. bruising and nosebleeds). Severe bleeding is uncommon, but may be life-threatening.

Seek immediate medical attention if any of the following symptoms occur – urgent medical help may be required:

• Intracranial bleeding (bleeding into the brain) is an uncommon adverse effect and may cause stroke-like symptoms such as:
  • sudden numbness or weakness in the arms, legs, or face, especially on one side of the body;
  • sudden confusion, difficulty speaking or understanding speech;
  • sudden difficulty walking, loss of balance or coordination;
  • sudden dizziness or sudden severe headache with no known cause.
• Symptoms of bleeding such as:
  • heavy or difficult-to-stop bleeding;
  • unexpected bleeding or bleeding that lasts a long time;
  • pink, red or brown urine;
  • vomiting blood or material that looks like coffee grounds;
  • red or black, tarry stools;
  • coughing up or vomiting blood clots.
• Fainting
  • temporary loss of consciousness caused by a sudden reduction in blood flow to the brain (common).
• 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.

Discuss with the doctor if the patient experiences:

• Shortness of breath – very common. This may be due to heart disease or another cause, or it may be an adverse effect of Ticatrom. Shortness of breath associated with Ticatrom is usually mild and characterized by sudden, unexpected breathlessness, typically at rest, which may occur during the first few weeks of treatment and then not recur for several weeks. If breathlessness worsens or persists for a long time, contact the doctor. The doctor will decide whether treatment or further investigations are necessary.

Other possible adverse effects
Very common (may affect more than 1 in 10 people)

• increased blood uric acid levels (detected in laboratory tests);
• bleeding due to blood disorders.

Common (may affect up to 1 in 10 people)

• bruising;
• headache;
• 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 normal 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 available data)

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store the medicine 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 and carton. The expiry date refers to the last day of the stated month.
The label on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot/LOT.
No special storage conditions are required for this medicine.
Medicines must 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 packaging and other information

What Ticatrom contains

• The active substance is ticagrelor. Each coated tablet contains 60 mg of ticagrelor.
• The other ingredients are: Tablet core: mannitol (E421), calcium hydrogen phosphate dihydrate, hypromellose 2910 (5 mPa·s), sodium carboxymethyl starch (type A), magnesium stearate. Coating composition: 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 pink, round, biconvex tablets with the imprint "60" on one side, with a diameter of 7.9–8.4 mm.
The medicine is packed in PVC/PVDC/Aluminium blisters in cardboard boxes.
Pack sizes: 14, 56, 60, 168, 180 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01