Ticatrom

Package Leaflet: Information for the Patient

Ticatrom, 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 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 Package 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 antiplatelet medicines.

What is Ticatrom used for

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

• myocardial infarction (heart attack) or
• unstable angina (chest pain or discomfort which is not well controlled). The medicine reduces the likelihood of having another heart attack or stroke, or dying from a heart or blood vessel-related condition.

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 damaged blood vessels.

However, platelets can also form clots inside 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 (myocardial infarction) or stroke, or
• a clot can cause partial blockage of the blood vessels leading to the heart, reducing blood flow to the heart and causing chest pain (unstable angina).

Ticatrom helps prevent platelets from clumping together, reducing the likelihood of a clot forming and blocking blood flow.

2. Important information before taking Ticatrom

When not to take Ticatrom

• if you are allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6);
• if you are currently 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). 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:

• if you have an increased risk of bleeding due to:
• a 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 are going to have surgery (including dental surgery) while taking Ticatrom. This is because of an increased risk of bleeding. Your doctor may advise you to stop taking the medicine 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 pauses in breathing. Your doctor will decide whether 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 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 important to inform your doctor that you are taking both Ticatrom and heparin, as Ticatrom may affect the test result.

Children and adolescents

Ticatrom should not be used in children and adolescents under 18 years of age.

Ticatrom and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any you plan to take. This is because Ticatrom may affect the way other medicines work, and other medicines may affect Ticatrom.
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).

Particularly 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), 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, often referred to as clot-busting medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding

Ticatrom should not be used during pregnancy or if you are planning to become pregnant.
While taking Ticatrom, 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. If you experience dizziness or confusion while taking the medicine, be careful when driving or using machines.

Ticatrom contains sodium

Ticatrom contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 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.

How much to take

• The initial dose is two tablets taken at the same time (loading dose of 180 mg). This dose is usually given in a hospital.
• After the initial dose, the usual dose is one 90 mg tablet taken 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 Ticatrom 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 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;
• add the powder to half a glass of water;
• mix and drink immediately;
• to ensure 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 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 be at risk of bleeding.

What to do if you forget to take Ticatrom

• 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 a forgotten 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 tells you. Stopping Ticatrom may increase the risk of having another heart attack or stroke, or dying from a heart or blood vessel-related condition.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ticatrom can cause side effects, although not everybody gets them.
While taking this medicine, the following side effects may occur:
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 occurs on one side of the body;
• sudden confusion, difficulty speaking or understanding others;
• sudden difficulty walking, loss of balance, or coordination;
• sudden dizziness or a severe headache with no known cause;
• symptoms of bleeding, 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 severe fatigue or confusion.

Tell your doctor if you experience:

• shortness of breath (dyspnea) - occurs very commonly.It may be caused by heart disease or another condition, or it may be a side effect of Ticatrom. Dyspnea associated with Ticatrom is usually mild and characterized by sudden, unexpected shortness of breath, often at rest, which may occur during the first few weeks of treatment and then resolve for many weeks. If shortness of breath worsens or persists, contact your doctor. Your doctor will decide whether 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 (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, which 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;
• confusion (disorientation);
• vision disturbances due to blood in the eye;
• vaginal bleeding, which is heavier or occurs at an unusual time (e.g., between menstrual periods);
• 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, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 that month.
The packaging is marked with the expiry date and batch number after the EXP and Lot/LOT abbreviations, respectively.
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 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 film-coated tablet contains 90 mg of ticagrelor.
• The other ingredients are: tablet core: mannitol (E421), calcium hydrogen phosphate dihydrate, hypromellose 2910 (5 mPa·s), sodium carboxymethylcellulose (type A), magnesium stearate. tablet coating: 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 an acceptable orange tint, round, biconvex, with a diameter of 8.9-9.4 mm.
Ticatrom is packaged in PVC/PVDC/Aluminum blisters in a cardboard box.
Pack sizes: 14, 56, 60, 168, 100, 180 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Date of last revision of the package leaflet: