Patient Information Leaflet: Read this leaflet carefully before using the medicine, as it contains important information for you.

Tilobrastil, 60 mg, coated tablets
Ticagrelor
Please read all of this leaflet carefully before you start 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 as yours.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Leaflet Contents:

What Tilobrastil is and what it is used for
Important information before taking Tilobrastil
How to take Tilobrastil
Possible side effects
How to store Tilobrastil
Contents of the pack and other information

1. What Tilobrastil is and what it is used for

What is Tilobrastil?
Tilobrastil contains an active substance called ticagrelor. It belongs to a group of medicines known as antiplatelet agents.

What is Tilobrastil used for?
Tilobrastil, 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.
This medicine reduces the risk of a further heart attack or stroke, or death due to heart or blood vessel disease.

How Tilobrastil works
Tilobrastil affects 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 blood vessel injury.

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 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 potentially causing chest pain of varying intensity (known as unstable angina).

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

2. Important information before using Tilobrastil

When not to use Tilobrastil
if the patient is allergic to ticagrelor or any of the other ingredients of this medicine
(listed in section 6);
if the patient is currently 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 atazanawir (used to treat HIV and AIDS infections).

Do not use Tilobrastil if any of the above situations apply to the patient. In
case of doubt, consult a doctor or pharmacist before starting
treatment with this medicine.
Warnings and precautions
Before taking Tilobrastil, 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 – advice should be sought from a dentist);
conditions affecting blood clotting;
recent gastrointestinal bleeding (such as gastric ulcer or intestinal polyps);
if the patient will undergo any surgical procedures (including dental) at any time during treatment with Tilobrastil. This is due to an increased risk of bleeding. The doctor may recommend stopping the medicine 5 days before a 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 apnea. The doctor will decide whether further evaluation is necessary;
if the patient has any liver disorders or has previously had a disease that could have damaged the liver;
if blood tests have shown elevated levels of uric acid in the patient.

Talk to a doctor or pharmacist before using this medicine if any of the
above situations apply to the patient (or if in doubt).
If the patient is taking Tilobrastil 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 Tilobrastil and heparin, as Tilobrastil may affect the diagnostic test result.
Children and adolescents
Tilobrastil is not recommended for use in children and adolescents under 18 years of age.
Tilobrastil and other medicines
Tell your doctor or pharmacist about all 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.
Inform your doctor or pharmacist if you are 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);
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).
Especially inform your doctor or pharmacist if you are 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 atazanawir (used to treat HIV and AIDS infections), cimetidine (used to treat heartburn), and ergot alkaloids (used to treat migraines and headaches).
You should also inform your doctor about taking Tilobrastil and the increased risk of bleeding if your doctor prescribes fibrinolytic medicines, often called clot-dissolving medicines, such as streptokinase or alteplase.
Pregnancy and breastfeeding
Tilobrastil 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 becoming pregnant.
Before using this medicine, inform your doctor if you are breastfeeding. Your doctor will discuss the benefits and risks associated with using Tilobrastil during breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
It is unlikely that Tilobrastil will impair the ability to drive or operate machinery. However, if dizziness or disorientation occurs while taking this medicine, caution should be exercised when driving or operating machinery.
Tilobrastil contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Tilobrastil

This medicine should always be taken exactly as prescribed by your doctor. If in doubt,
contact your doctor or pharmacist.
What dose to use
The usual dose is one 60 mg tablet twice daily. You should continue taking Tilobrastil for as long
as your doctor recommends.
Take the medicine at approximately the same time each 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 an active
substance found in many medicines that prevent blood clotting. Your doctor will advise you on the
dose to take (usually between 75 and 150 mg per day).
How to take Tilobrastil
Tablets may be taken with or without food.
You can check when you last took a tablet by looking at the blister pack. The blister contains
imprints showing a sun (for morning doses) and a moon (for evening doses). These imprints help
patients remember when they last took their dose.
What to do if you have difficulty swallowing the tablet
If you have 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 you are being treated in hospital, the tablet may be dissolved in water and administered through
a nasal tube (nasogastric tube).
Taking more Tilobrastil than recommended
If you take more Tilobrastil than prescribed, contact your doctor immediately or go to hospital.
Take the medicine pack with you. There may be an increased risk of bleeding.
If you miss a dose of Tilobrastil
If you miss a dose, take the next dose at your usual time.
Do not take a double dose (two doses at the same time) to make up for a missed dose.
Stopping 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 having
another heart attack or stroke, or of dying from a heart or blood vessel-related disease.
If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following adverse effects may occur during treatment with this medicine:
Ticagrelor affects blood clotting; therefore, most adverse effects are related to bleeding. Bleeding may occur at any site in the body. Some bleeding events are common (e.g. bruises and nosebleeds). Severe bleeding occurs uncommonly but may be life-threatening.
Contact a doctor immediately if any of the following symptoms occur – urgent medical care may be needed:
Bleeding into the brain or intracranial bleeding is an uncommon adverse effect and may cause stroke-like symptoms such as:
sudden numbness or weakness of 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 bleeding or bleeding that is difficult to stop;
unexpected bleeding or bleeding that lasts a long time;
urine that is pink, red, or brown;
vomiting blood or vomit that looks like coffee grounds;
stool that is red or black (resembling tar);
coughing 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. It may be caused by heart disease or another condition, or it may be an adverse effect of Tilobrastil. Shortness of breath associated with ticagrelor 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 many weeks. If shortness of breath worsens or persists for a long time, contact a doctor. The doctor will decide whether treatment or additional tests are needed.
Other adverse effects
Very common (may affect more than 1 in 10 people)
increased uric acid levels in blood (detected in laboratory tests)
bleeding due to blood disorders
Common (may affect fewer than 1 in 10 people):
bruising
headaches
dizziness or vertigo
diarrhea 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 fewer than 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 presence of blood in the eye
bleeding from the reproductive tract 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 (frequency 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 a doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 Tilobrastil

Keep out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month indicated.
No special storage conditions required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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 components are:
Tablet core: mannitol, calcium hydrogen phosphate dihydrate, maize starch, pregelatinized starch (maize), talc, sodium stearyl fumarate.
Tablet coating: polyvinyl alcohol, talc, titanium dioxide (E 171), glycerol monocaprylocaproyl ester, sodium lauryl sulfate, red iron oxide (E 172), black iron oxide (E 172).

What Tilobrastil looks like and contents of the pack
Coated tablet: the tablets are round, biconvex, pink, with the imprint “60” on one side and smooth on the other, with a diameter of 8.6 mm ± 5%.
Tilobrastil is available in blisters (with sun or moon symbols or without them) in cardboard boxes containing 56 or 60 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised in the European Economic Area under the following names:
Netherlands Tilobrastil 60 mg, filmomhulde tabletten
Bulgaria Тилобрастил 60 mg филмирани таблетки
Estonia Tilobrastil
Croatia Tilobrastil 60 mg filmom obložene tablete
Lithuania Tilobrastil 60 mg plėvele dengtos tabletės
Latvia Tilobrastil 60 mg apvalkotās tabletes
Poland Tilobrastil
Slovenia Tilobrastil 60 mg filmsko obložene tablete

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. +48 22 209 70 00