TROMBEX 75 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. TROMBEX, 75 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Trombex and what is it used for
4. Important information before taking Trombex
   1. When not to take Trombex
   2. Warnings and precautions
   3. Children and adolescents
   4. Trombex with other medicines
   5. Trombex with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Trombex contains lactose
   9. Trombex contains hydrogenated castor oil
5. How to take Trombex
   1. Take a higher dose of Trombex than recommended
   2. Miss a dose of Trombex
   3. Stop taking Trombex
6. Possible side effects
   1. The patient should immediately contact their doctor if they experience:
   2. If the patient experiences prolonged bleeding while taking Trombex
   3. Other side effects
   4. Reporting side effects
   5. Marketing authorisation holder:
   6. Manufacturer:
   7. Importer:
   8. This medicine is authorised in the Member States of the European Economic Area under the following names:
   9. For more information about this medicine, the patient should contact:

Package Leaflet: Information for the Patient

TROMBEX, 75 mg, Film-Coated Tablets

Clopidogrel

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 the leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Trombex and what is it used for

Trombex contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small blood cells that clump together during blood clotting. By preventing this clumping, antiplatelet agents reduce the chance of blood clots forming (a process known as thrombosis).
Trombex is used to prevent blood clots (thrombi) in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, myocardial infarction, or death).
Trombex is prescribed to adults to prevent blood clots and reduce the risk of these severe events because:
the patient has a condition known as atherothrombosis (where the arteries become clogged with fatty substances) and
the patient has previously experienced a heart attack, stroke, or has a condition known as peripheral arterial disease, or
the patient has experienced severe chest pain (unstable angina or myocardial infarction). To treat this condition, the doctor may place a stent in the blocked or narrowed artery to restore effective blood flow. The doctor may also recommend taking acetylsalicylic acid (a substance found in many medicines, used to relieve pain and reduce fever, as well as to prevent blood clotting).
the patient has experienced symptoms of a stroke that have resolved quickly (known as a transient ischaemic attack) or a mild stroke. The doctor may also prescribe acetylsalicylic acid within the first 24 hours.
the patient has an irregular heartbeat, a condition known as atrial fibrillation, and the patient cannot take medicines known as "oral anticoagulants" (antagonists of vitamin K), which prevent the formation of new blood clots and the growth of existing clots. The doctor should inform the patient that "oral anticoagulants" are more effective in these cases than acetylsalicylic acid or the combination of Trombex and acetylsalicylic acid. The doctor should prescribe Trombex and acetylsalicylic acid if the patient cannot take "oral anticoagulants" and does not have a risk of severe bleeding.

2. Important information before taking Trombex

When not to take Trombex

• if the patient is allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
• if the patient has a medical condition that is currently causing bleeding, such as a stomach ulcer or bleeding in the brain.
• if the patient has severe liver disease.

If any of the above situations occur or if there are any doubts, the patient should consult a doctor before taking Trombex.

Warnings and precautions

Before starting treatment with this medicine, the patient should discuss it with their doctor or pharmacist:
if there is a risk of bleeding, such as:
a medical condition that increases the risk of internal bleeding (such as a stomach ulcer).
a blood disorder that increases the risk of internal bleeding (bleeding into tissues, organs, or joints).
a recent severe injury.
a recent surgical procedure (including dental surgery).
a planned surgical procedure (including dental surgery) within the next seven days.
if the patient has had a blood clot in the brain (ischaemic stroke) in the last seven days.
if the patient has kidney or liver disease.
if the patient has ever had an allergic reaction or other reactions to a medicine used to treat their condition.
if the patient has had a non-traumatic brain haemorrhage.
While taking Trombex:

• the patient should inform their doctor about any planned surgical procedure (including dental surgery).
• the patient should also immediately inform their doctor if they experience a medical condition known as thrombotic thrombocytopenic purpura (TTP), which is characterised by fever, bruising under the skin that may appear as red pinpoint dots, with or without severe fatigue of unknown cause, confusion, yellowing of the skin or eyes (jaundice) (see section 4 "Possible side effects").
• in case of a cut or injury, bleeding may take longer than usual to stop. This is due to the way the medicine works, by preventing the formation of blood clots. For minor cuts or wounds, such as a cut or scratch while shaving, this is usually of no concern. However, if there is any unusual bleeding, the patient should immediately contact their doctor (see section 2 "Warnings and precautions").
• the doctor may order blood tests.

Children and adolescents

Trombex should not be used in children and adolescents, as it is not effective in this patient group.

Trombex with other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
Some other medicines may affect the use of Trombex, and Trombex may affect the use of other medicines.
In particular, the patient should inform their doctor if they are taking medicines such as:

• medicines that may increase the risk of bleeding, such as:
  oral anticoagulants, medicines used to prevent blood clotting,
  non-steroidal anti-inflammatory drugs, usually used to treat painful and/or inflammatory conditions of the muscles or joints,
  heparin or other injectable medicines used to reduce blood clotting,
  ticlopidine or other antiplatelet agents,
  selective serotonin reuptake inhibitors (including fluoxetine or fluvoxamine), medicines usually used to treat depression,
  rifampicin (used to treat severe infections),
• omeprazole or esomeprazole, medicines used to treat stomach disorders,
• fluconazole or voriconazole, medicines used to treat fungal infections,
• efavirenz or other antiretroviral medicines (used to treat HIV infection),
• a medicine used to treat HIV infection (human immunodeficiency virus),
• carbamazepine, a medicine used to treat certain types of epilepsy,
• moclobemide, a medicine used to treat depression,
• repaglinide, a medicine used to treat diabetes,
• paclitaxel, a medicine used to treat cancer,
• opioids: during treatment with clopidogrel, the patient should inform their doctor before prescribing any opioid (medicines used to treat severe pain),
• rosuvastatin (a medicine used to lower cholesterol levels).

If the patient has experienced severe chest pain (unstable angina or myocardial infarction), a transient ischaemic attack, or a mild stroke, it is possible that the doctor will decide to recommend taking acetylsalicylic acid in addition to Trombex, a substance found in many medicines with analgesic and antipyretic effects. Occasional use of acetylsalicylic acid (no more than 1000 mg in 24 hours) is usually not a problem, but long-term use in other circumstances should be discussed with a doctor.

Trombex with food and drink

The medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

The use of this medicine is not recommended during pregnancy.
If the patient is pregnant or thinks they may be pregnant, they should tell their doctor or pharmacist before taking Trombex. If the patient becomes pregnant while taking Trombex, they should immediately consult their doctor, as the use of clopidogrel during pregnancy is not recommended.
Breastfeeding is not recommended while taking this medicine. If the patient is breastfeeding or plans to breastfeed, they should tell their doctor before taking the medicine.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Trombex does not affect the ability to drive or use machines.

Trombex contains lactose

If the patient has been diagnosed with an intolerance to some sugars, they should contact their doctor before taking the medicine.

Trombex contains hydrogenated castor oil

It may cause stomach upset or diarrhoea.

3. How to take Trombex

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient is unsure, they should ask their doctor or pharmacist.
The recommended dose of Trombex is 75 mg per day, taken orally at the same time each day, with or without food. This dosage also applies to patients with a condition known as atrial fibrillation (irregular heartbeat).
If the patient has experienced severe chest pain (unstable angina or myocardial infarction), the doctor may decide to use a single dose of 300 mg or 600 mg of Trombex (4 or 8 tablets of 75 mg) at the start of treatment. Then, the recommended dose of Trombex is one 75 mg tablet per day (as above).
If the patient has experienced symptoms of a stroke that have resolved quickly (also known as a transient ischaemic attack) or a mild stroke, the doctor may prescribe a single dose of 300 mg of Trombex (4 tablets of 75 mg) at the start of treatment. Then, the recommended dose is one Trombex tablet, 75 mg per day, as described above, with acetylsalicylic acid for 3 weeks. Then, the doctor may prescribe Trombex or acetylsalicylic acid separately.
Trombex should be taken for as long as the doctor recommends.

Take a higher dose of Trombex than recommended

The patient should contact their doctor or the nearest hospital emergency department due to the increased risk of bleeding.

Miss a dose of Trombex

If the patient forgets to take Trombex but remembers within 12 hours of the scheduled time, they should take the tablet immediately and then take the next dose at the usual time.
If more than 12 hours have passed, the patient should take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.
For packs containing 7, 14, 28, and 84 tablets, two types of blisters may be available (i.e., with a printed calendar on the blister or without).

Stop taking Trombex

The patient should not stop treatment unless their doctor tells them to. The patient should contact their doctor or pharmacist before stopping treatment.
If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Trombex can cause side effects, although not everybody gets them.

The patient should immediately contact their doctor if they experience:

fever, signs of infection, or a feeling of extreme tiredness. This may be due to a rare decrease in the number of certain blood cells.
symptoms of liver dysfunction, such as yellowing of the skin and/or eyes (jaundice), with or without bleeding, which may appear as red pinpoint dots under the skin and/or confusion (see section 2 "Warnings and precautions").
swelling in the mouth or skin disorders, such as: rash, itching, blisters on the skin. These may be symptoms of an allergic reaction.
The most common side effect reported with clopidogrel(the active substance in Trombex) is bleeding.Bleeding may occur as stomach or intestinal bleeding, bruising, haematomas (unusual bleeding or bruising under the skin), nosebleeds, or blood in the urine. In rare cases, bleeding has also been reported in the eye, head, lungs, or joints.

If the patient experiences prolonged bleeding while taking Trombex

In case of a cut or injury, bleeding may take longer than usual to stop. This is due to the way the medicine works, by preventing the formation of blood clots.
For minor cuts or wounds, such as a cut or scratch while shaving, this is usually of no concern. However, if there is any unusual bleeding, the patient should immediately contact their doctor (see section 2 "Warnings and precautions").

Other side effects

Common(may affect up to 1 in 10 people):
diarrhoea, stomach pain, indigestion, or heartburn.
Uncommon(may affect up to 1 in 100 people):
headache, stomach ulcer, vomiting, nausea, constipation, gas in the stomach or intestines, rash, itching, dizziness, feeling of tingling or numbness.
Rare(may affect up to 1 in 1,000 people):
vertigo of labyrinthine origin, gynaecomastia (breast enlargement in men).
Very rare(may affect up to 1 in 10,000 people):
jaundice; severe stomach pain with or without back pain; fever, difficulty breathing sometimes with cough; generalised allergic reaction, e.g., general feeling of heat with sudden general discomfort, leading to fainting; swelling of the mouth; blisters on the skin; skin allergic reaction; mouth pain (stomatitis); low blood pressure; confusion; hallucinations; joint pain; muscle pain; taste disturbances or loss of taste.
Side effects of unknown frequency(frequency cannot be estimated from the available data):
Hypersensitivity reactions with chest pain or stomach pain, persistent symptoms of low blood sugar.
The doctor may also find changes in the results of blood or urine tests.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181 C, 02-222 Warsaw.
Phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be gathered on the safety of the medicine.
Side effects can also be reported to the marketing authorisation holder or its representative in Poland.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP:". The expiry date refers to the last day of the month stated.
Glass bottle
Store in the original package to protect from moisture.
After first opening the package, store in a temperature below 25°C and use within 3 months.
PVC/PVDC/Aluminium blister
Store in the original package to protect from moisture.
Store in a temperature below 30°C.
Do not use this medicine if the patient notices any signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.
Brown glass bottle with HDPE cap and desiccant
Package size: 28, 30, 90 film-coated tablets.
PVC/PVDC/Aluminium blister
Package size: 7, 14, 28, 30, 84, 90, 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder:

Zentiva k.s., U Kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic.

Manufacturer:

Zentiva k.s., U Kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic.
Sanofi Winthrop Industrie, 1 rue de la Vierge, Ambares at Lagrave, 33565 Carbon Blanc cedex, France.
S.C. Zentiva S.A., B-dul Theodor Pallady nr 50, Sector 3, Bucharest 032266, Romania

Importer:

S.C. Zentiva S.A., B-dul Theodor Pallady nr 50, Sector 3, Bucharest 032266, Romania
Zentiva k.s. U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

This medicine is authorised in the Member States of the European Economic Area under the following names:

Bulgaria:Тромбекс 75 mg филмирани таблетки
Estonia:Trombex 75 mg
Lithuania:Trombex 75 mg plėvele dengtos tabletės
Latvia:Trombex 75 mg apvalkotās tabletes
Poland:Trombex
Czech Republic:Trombex
Slovakia:TROMBEX 75 mg filmom obalené tablety
Romania:TROMBEX, 75 mg, comprimate filmate
Hungary:Trombex 75 mg filmtabletta

For more information about this medicine, the patient should contact:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
phone: +48 22 375 92 00
Date of last revision of the leaflet:August 2023