Tilobrastil

Leaflet attached to the packaging: patient information

Tilobrastil, 60 mg, coated tablets

Ticagrelor

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Tilobrastil and what is it used for

What is Tilobrastil

Tilobrastil contains the active substance ticagrelor. It belongs to a group of medicines called antiplatelet medicines.

What is Tilobrastil used for

Tilobrastil is used in combination with acetylsalicylic acid (another antiplatelet medicine) only in adults who have had:
heart attack more than a year ago.
The medicine reduces the likelihood of another heart attack or stroke, or death due to heart or blood vessel disease.

How Tilobrastil works

Tilobrastil works by affecting cells called platelets in the blood (also called thrombocytes). Platelets are very small blood cells that help stop bleeding by clumping together and blocking small holes in injured blood vessels.
However, platelets can also form clots inside blood vessels in the heart and brain. This can be very dangerous because:
a clot can completely block the flow of blood - this can cause a heart attack (heart muscle) or stroke, or
a clot can cause partial blockage of blood vessels leading to the heart - which reduces blood flow to the heart and can cause chest pain of varying intensity (called unstable angina).
Tilobrastil helps prevent platelets from clumping together, reducing the likelihood of a clot forming that could reduce blood flow.

2. Important information before taking Tilobrastil

When not to take Tilobrastil

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 infections).

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

Warnings and precautions

Before taking Tilobrastil, 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 Tilobrastil. This is because there is 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 heart rate that is too slow (usually less than 60 beats per minute) and you 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 shortness of breath. Your doctor will decide whether further evaluation is needed; if you have any liver problems or have had a disease in the past that could have damaged your liver; if your blood test shows high levels of uric acid.

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

Children and adolescents

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

Tilobrastil and other medicines

Tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This is necessary because Tilobrastil may affect the action of other medicines, and other medicines may affect Tilobrastil.
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 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 called 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 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), cisapride (used to treat heartburn), and ergot alkaloids (used to treat migraines and headaches).
Also, tell your doctor if you are taking Tilobrastil and have an increased risk of bleeding if your doctor prescribes fibrinolytic medicines, often called clot-busting medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding

Tilobrastil 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, tell your doctor if you are breastfeeding. Your doctor will discuss the benefits and risks of taking Tilobrastil while breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

It is unlikely that Tilobrastil will affect your ability to drive or use machines. If you experience dizziness or disorientation while taking the medicine, be careful when driving or using machines.

Tilobrastil contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Tilobrastil

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 usual dose is one 60 mg tablet twice a day. Continue taking Tilobrastil for as long as your doctor recommends.
Take the medicine at the same time every day (e.g., one tablet in the morning and one in the evening).

Taking Tilobrastil 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 tell you what dose to take (usually between 75 and 150 mg per day)

How to take Tilobrastil

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 trouble swallowing the tablet

If you have trouble 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 make sure you take all the medicine, refill the glass with half a glass of water, rinse, and drink.
If you are being treated in a hospital, the crushed tablet can be given through a nasogastric tube.

What to do if you take more Tilobrastil than you should

If you take more Tilobrastil than you should, contact your doctor or go to the hospital immediately. Take the medicine packaging with you.
There may be an increased risk of bleeding.

What to do if you forget to take Tilobrastil

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 the missed dose.

What to do if you stop taking Tilobrastil

Do not stop taking Tilobrastil without talking to your doctor. You should take the medicine regularly and for as long as your doctor recommends. Stopping Tilobrastil may increase the risk of another heart attack or stroke, or death due to heart or blood vessel disease.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur when taking this medicine:
Ticagrelor affects blood clotting, so most side effects are related to bleeding. Bleeding can occur anywhere in the body. Some bleeding is common (e.g., bruising and nosebleeds). Severe bleeding is not common but can be life-threatening.

Seek medical help immediately if you experience any of the following symptoms - you may need urgent medical attention: bleeding in the brain or inside the skull is an uncommon side effect and may cause stroke-like symptoms, such as:

do not delay and seek medical help immediately if you experience:
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.
symptoms of bleeding, such as:
heavy or uncontrollable 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 coal);
coughing or vomiting blood clots.
fainting
temporary loss of consciousness due to a sudden decrease 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 confusion.

Tell your doctor if you experience:

shortness of breath (dyspnea) - very common.It may be caused by heart disease or another cause, or it may be a side effect of Tilobrastil. Dyspnea associated with ticagrelor is usually mild and characterized by sudden, unexpected shortness of breath, usually at rest, and may occur during the first few weeks of treatment and then not occur for many weeks. If dyspnea worsens or persists, consult your doctor. Your doctor will decide whether treatment or further tests are needed.

Other side effects

Very common (may affect more than 1 in 10 people)

increased uric acid levels in the blood (found 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 - these are symptoms of gout
dizziness or lightheadedness or blurred vision - these are symptoms of low blood pressure
nosebleeds
bleeding after surgery or from cuts and wounds, which is more 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
confusion (disorientation)
vision problems due to blood in the eye
bleeding from the reproductive tract, which is heavier or occurs at a different time than regular menstrual bleeding
bleeding into the joints and muscles, causing painful swelling
blood in the ear
internal bleeding, which can 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, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Medicines Monitoring, 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
You can also report side effects 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 Tilobrastil

Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of that month.
No special storage precautions are required.
Medicines should 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 pack and other information

What Tilobrastil contains

• The active substance is ticagrelor. Each coated tablet contains 60 mg of ticagrelor.
• The other ingredients are: tablet core:mannitol, calcium hydrogen phosphate dihydrate, corn starch, corn starch paste, talc, sodium stearyl fumarate. tablet coating: polyvinyl alcohol, talc, titanium dioxide (E 171), glyceryl monocaprylate, sodium lauryl sulfate, iron oxide red (E 172), iron oxide black (E 172).

What Tilobrastil looks like and contents of the pack

Coated tablet: tablets are round, biconvex, pink, with "60" engraved on one side and smooth on the other, with a diameter of 8.6 mm ± 5%.
Tilobrastil is available in blister packs (with sun or moon symbols or without them) in cartons containing 56 or 60 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria
Manufacturer
PharOS MT Ltd
HF 62X, Hal Far Industrial Estate
Birzebbugia, BBG3000
Malta
Lek Pharmaceuticals d.d.
Verovskova Ulica 57
1526 Ljubljana
Slovenia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands
Tilobrastil 60 mg, film-coated tablets
Bulgaria
Тилобрастил 60 mg филмиранитаблетки
Estonia
Tilobrastil
Croatia
Tilobrastil 60 mg film-coated tablets
Lithuania
Tilobrastil 60 mg film-coated tablets
Latvia
Tilobrastil 60 mg apvalkotās tabletes
Poland
Tilobrastil
Slovenia
Tilobrastil 60 mg filmsko obložene tablete

For further information about this medicine, contact the local representative of the marketing authorization holder:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. +48 22 209 70 00
Date of last revision of the leaflet:12/2024
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