Tilobrastil

Patient Information Leaflet: Instructions for the Patient

Tilobrastil, 90 mg, coated tablets
Ticagrelor
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others.
• This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents:

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

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

What Tilobrastil is used for
Tilobrastil, in combination with acetylsalicylic acid (another antiplatelet medicine), is used only in adults who have experienced:
a heart attack or
unstable angina (chest pain or discomfort that is not adequately controlled).
The medicine reduces the risk of another heart attack or stroke, or death due to heart or blood vessel disease.

How Tilobrastil works
Tilobrastil 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 may 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 lead to a heart attack (of the heart muscle) 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 of varying intensity (called unstable angina).

Tilobrastil helps prevent platelets from clumping together, thereby reducing the likelihood 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 experienced 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 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 using 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 – consult a dentist regarding this);
• a condition affecting blood clotting;
• recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps);
• if the patient will undergo any surgical procedure (including dental) during treatment with Tilobrastil. This is due to an increased risk of bleeding. The doctor may recommend discontinuing the medicine 5 days before the planned procedure;
• if the patient has abnormally 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 disorders 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 suffered from a condition that could have damaged the liver;
• if blood tests have shown elevated levels of uric acid.

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 simultaneously:
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, have recently taken, or 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 reduce cholesterol levels);
simvastatin or lovastatin at doses exceeding 40 mg daily (medicines used to reduce cholesterol levels);
rifampicin (an antibiotic);
phenytoin, carbamazepine, and phenobarbital (used to control 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-thinning medicines, 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 infections), cimetidine (used to treat heartburn), 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 should use appropriate contraceptive methods while taking this medicine to avoid pregnancy.

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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a 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 during treatment, 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 used exactly as your doctor has told you. If in doubt,
contact your doctor or pharmacist.
What dose to use
The initial dose is two tablets taken at the same time (loading dose of 180 mg).
This dose is usually administered in hospital.
After the initial dose, the usual dose is one 90 mg tablet taken twice daily for up to 12 months,
unless your doctor advises otherwise.
You should take the medicine every day at approximately the same time (e.g. one tablet in the
morning and one in the evening).
Taking Tilobrastil with other medicines that prevent blood clotting
Your doctor will usually recommend taking acetylsalicylic acid at the same time. This is a substance
present in many medicines used to prevent blood clotting. Your doctor will tell you what dose to
take (usually between 75 and 150 mg daily).
How to take Tilobrastil
The 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
you remember when you last took your 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 that all the medicine is taken, pour another half glass of water, swirl and drink.
If you are being treated in hospital, the tablet dissolved in water may be given through a nasal
tube (nasogastric tube).
Taking more Tilobrastil than recommended
If you take more Tilobrastil than you should, contact your doctor or go to hospital immediately.
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 forgotten 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 tells you to. Stopping Tilobrastil may increase the risk of having
another heart attack or stroke, or of dying from a heart- or blood vessel-related condition.
If you have any further questions about the use of this medicine, contact your 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:
Ticagrelor affects blood clotting; therefore, most adverse reactions are related to bleeding. Bleeding may occur at any site in the body. Some bleeding events are common (e.g., bruising and nosebleeds). Severe bleeding occurs uncommonly but may be life-threatening.
Seek immediate medical attention if any of the following symptoms occur – urgent medical help may be needed:
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 if affecting only 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 without known cause.
Signs of bleeding such as:
heavy bleeding or bleeding that is difficult to stop;
unexpected bleeding or bleeding that lasts a very long time;
urine that is pink, red, or brown;
vomiting blood or material 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 (dyspnoea) – very common. It may be caused by heart disease or another condition, or it may be an adverse reaction to Tilobrastil. Dyspnoea 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 the doctor. The doctor will decide whether treatment or additional tests are needed.
Other adverse reactions
Very common (may occur in more than 1 in 10 people)
increased blood uric acid levels (detected in laboratory tests)
bleeding due to blood disorders
Common (may occur in less than 1 in 10 people):
bruising
headaches
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 bleed more than usual
bleeding from the stomach lining (ulcer)
bleeding gums
Uncommon (may occur in less 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)
visual disturbances caused by blood in the eye
bleeding from the genital 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 reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Tilobrastil

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the cardboard
box after EXP. The expiry date refers to the last day of the specified month.
No special storage conditions are required.
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 packaging and other information

What Tilobrastil contains

• The active substance is ticagrelor. Each coated tablet contains 90 mg of ticagrelor.
• Other ingredients 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 monocaprylocaprate, sodium lauryl sulfate, yellow iron oxide (E 172).

What Tilobrastil looks like and contents of the pack
Film-coated tablet: tablets are round, biconvex, yellow,
with the imprint "90" on one side and smooth on the other, with a diameter of 9.6 mm ± 5%.
Tilobrastil is available in blister packs (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

Manufacturers
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 member states of the European Economic Area under the following names:
Netherlands: Tilobrastil 90 mg, filmomhulde tabletten
Bulgaria: Tilobrastil 90 mg филмирани таблетки
Estonia: Tilobrastil
Croatia: Tilobrastil 90 mg filmom obložene tablete
Lithuania: Tilobrastil 90 mg plėvele dengtos tabletės
Latvia: Tilobrastil 90 mg apvalkotās tabletes
Poland: Tilobrastil
Slovenia: Tilobrastil 90 mg filmsko obložene tablete

For more detailed information on 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