Ticatrom

Package leaflet: Information for the patient

Ticatrom, 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. 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 someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Ticatrom is and what it is used for
2. What you need to know 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 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 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 at the site of a cut or damaged blood vessel.

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 – which 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 (called unstable angina).

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

2. Important information before using Ticatrom

When not to use Ticatrom

• 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 atazanavir (used to treat HIV and AIDS viral infections).
    Do not take Ticatrom 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 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);
  • a medical condition affecting blood clotting;
  • recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps);
• if the patient is scheduled to undergo any surgical procedure (including dental) 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 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 show elevated levels of uric acid.

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 Ticatrom and heparin at the same time:

• 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 and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. 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 lower cholesterol levels);
• simvastatin or lovastatin at doses higher than 40 mg per day (medicines used to lower cholesterol levels);
• rifampicin (an antibiotic);
• phenytoin, carbamazepine, and phenobarbital (used to control epileptic seizures);
• digoxin (used to treat heart failure);
• cyclosporyne (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 viral infections), cisapride (used to treat heartburn), and ergot alkaloids (used to treat migraines and headaches).

Also inform the doctor about taking Ticatrom and the associated 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 should use appropriate contraceptive methods while taking this medicine to avoid pregnancy.
Inform the doctor if the patient is 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 using machines
It is unlikely that Ticatrom will impair the ability to drive or operate machinery. However, if dizziness or confusion occurs during treatment, 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.

What dose to take

• The initial dose is two tablets taken at the same time (a loading dose of 180 mg). This dose is usually given in hospital.
• After the initial dose, the usual maintenance dose is one 90 mg tablet taken twice daily for up to 12 months, unless the doctor advises 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 Ticatrom with other blood-thinning medicines
The doctor will usually recommend taking acetylsalicylic acid at the same time. This is a substance found in many medicines used to prevent blood clotting. The doctor will advise on the dose to take (usually between 75 and 150 mg per day).

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 dissolved in water may be administered via a nasogastric tube.

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

Missing a dose of Ticatrom

• 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 consulting a doctor. The medicine should be taken regularly and for as long as the doctor recommends. Stopping Ticatrom may increase the risk of another 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during treatment with this medicine:
Ticatrom 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 is uncommon but may be life-threatening.
You should contact your doctor immediately if any of the following symptoms occur – urgent medical care may be required:

• Intracranial haemorrhage (bleeding into the brain) is an uncommon adverse reaction and may cause stroke-like symptoms such as:
  • sudden numbness or weakness in arms, legs, or face, especially on 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 or difficult-to-stop bleeding;
  • 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;
  • red or black (tarry-looking) 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.

You should discuss with your doctor if the patient experiences:

• Shortness of breath (dyspnoea) – very common. It may be caused by heart disease or another condition, or it may be an adverse reaction to Ticatrom. Dyspnoea associated with Ticatrom is usually mild and characterized by sudden, unexpected shortness of breath, usually occurring at rest. It may appear during the first few weeks of treatment and then not recur for several weeks. If dyspnoea worsens or persists for a long time, contact your doctor. The doctor will decide whether treatment or additional tests are necessary.

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

• increased blood uric acid levels (detected in laboratory tests);
• bleeding caused by 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 minor cuts (e.g. during shaving) and wounds that is heavier than usual;
• bleeding from gastric mucosa (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 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 reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products, 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 Ticatrom

Keep this medicine out of 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.
There are no special storage instructions 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. These measures 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 90 mg of ticagrelor.
• Other ingredients are:
  Tablet core: mannitol (E421), calcium hydrogen phosphate dihydrate, hypromellose 2910 (5 mPa·s), sodium carboxymethyl starch (type A), magnesium stearate.
  Coating ingredients: hypromellose 2910 (6 mPa·s), titanium dioxide (E171), talc, macrogol 8000, yellow iron oxide (E172).

What Ticatrom looks like and contents of the pack
Light yellow tablets with a permissible orange tint, round, biconvex,
with a diameter of 8.9–9.4 mm.
The medicine is packed in PVC/PVDC/aluminum blisters, placed in a cardboard box.
Pack sizes: 56, 60, 100, 168, and 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