Trombex

Package leaflet: Information for the patient

TROMBEX, 75 mg, coated tablets
Clopidogrel
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, 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.

Table of contents

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

Trombex contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small components in the blood that stick together during blood clotting. By preventing this clumping process, antiplatelet medicines reduce the risk of blood clots forming (a process known as thrombosis).

Trombex is used to prevent blood clots (thrombi) from forming in hardened blood vessels (arteries) due to atherosclerosis, a condition known as atherothrombosis, which may lead to atherothrombotic events (such as stroke, heart attack, or death).

Trombex is prescribed for adults to prevent blood clots and reduce the risk of these serious events because:

• the patient has atherosclerosis (hardening of the arteries) and
• the patient has previously had a heart attack, stroke, or has peripheral arterial disease, or
• the patient has experienced acute chest pain known as "unstable angina" or "myocardial infarction" (heart attack). To treat this condition, the doctor may place a stent in the blocked or narrowed artery to restore adequate blood flow. The treating doctor may also recommend the patient take 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 had transient ischaemic attack (TIA) or a mild stroke. The treating doctor may also prescribe acetylsalicylic acid within the first 24 hours.
• the patient has an irregular heartbeat, a condition known as "atrial fibrillation", and cannot take medicines called "oral anticoagulants" (vitamin K antagonists), which prevent the formation of new clots and prevent existing clots from enlarging. The doctor should inform the patient that "oral anticoagulants" are more effective in such cases than acetylsalicylic acid or the combination of Trombex and acetylsalicylic acid. The doctor should prescribe Trombex together with acetylsalicylic acid only if the patient cannot take "oral anticoagulants" and does not have a high risk of serious bleeding.

2. Important information before using Trombex

When not to use Trombex

• if the patient has a known allergy (hypersensitivity) to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
• if the patient currently has a medical condition 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 apply, or if there are any doubts, consult a doctor before using Trombex.

Warnings and precautions

Before starting to take this medicine, discuss with your doctor or pharmacist if:

• there is a risk of bleeding, such as:
  • a medical condition that increases the risk of internal bleeding (e.g. stomach ulcer).
  • a blood disorder causing increased tendency to internal bleeding (bleeding inside tissues, organs, or joints).
  • recent severe trauma.
  • recent surgical procedure (including dental surgery).
  • planned surgical procedure (including dental surgery) within the next seven days.
• the patient has had a cerebral artery thrombosis (ischaemic stroke) that occurred within the last seven days.
• the patient has kidney or liver disease.
• the patient has ever had an allergic reaction or other adverse reactions to any medicine used to treat their condition.
• the patient has previously experienced non-traumatic intracranial haemorrhage.

While taking Trombex:

• inform your doctor about any planned surgical procedure (including dental procedures).
• immediately inform your doctor if you develop a medical condition called thrombotic thrombocytopenic purpura (TTP), characterised by fever, subcutaneous petechiae (which may appear as red, pinpoint spots), with or without extreme unexplained fatigue, confusion, or jaundice (yellowing of the skin or eyes) (see section 4 "Possible side effects").
• if you get a cut or injury, bleeding may last longer than usual. This is due to the way the medicine works, by inhibiting blood clot formation. For minor cuts or wounds, such as a shaving cut, this is usually not significant. However, if bleeding is concerning, contact your doctor immediately (see section 4 "Possible side effects").
• your doctor may decide to perform 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

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including over-the-counter medicines.

Some medicines may affect the use of Trombex, and Trombex may affect other medicines.

In particular, inform your doctor if you are taking:

• medicines that may increase the risk of bleeding, such as:
  • oral anticoagulants, medicines used to inhibit blood clotting,
  • non-steroidal anti-inflammatory drugs (NSAIDs), usually used to treat pain and/or inflammation of muscles or joints,
  • heparin or any other injectable medicines used to reduce blood clotting,
  • ticlopidine or other antiplatelet medicines,
  • selective serotonin reuptake inhibitors (SSRIs), including fluoxetine or fluvoxamine, usually used to treat depression,
  • rifampicin (used to treat serious infections),
• omeprazole or esomeprazole, medicines used to treat stomach problems,
• 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 (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, patients should inform their doctor before being prescribed any opioid (medicines used to treat severe pain),
• rosuvastatin (a medicine used to lower cholesterol levels).

If the patient experiences severe chest pain (unstable angina or myocardial infarction), transient ischaemic attack, or mild stroke, the doctor may decide to prescribe acetylsalicylic acid in addition to Trombex. Acetylsalicylic acid is a substance found in many pain-relieving and fever-reducing medicines. Occasional use of acetylsalicylic acid (not exceeding 1000 mg within 24 hours) is generally not expected to cause problems, but long-term use in other circumstances should be discussed with a doctor.

Trombex with food and drink

This medicine can be taken with or without food.

Pregnancy, breastfeeding and fertility

This medicine is not recommended during pregnancy.

If the patient is pregnant or suspects she may be pregnant, she should inform her doctor or pharmacist before taking Trombex. If pregnancy occurs during treatment with Trombex, consult a doctor immediately, as clopidogrel use during pregnancy is not recommended.

Breastfeeding is not recommended during treatment with this medicine. If the patient is breastfeeding or planning to breastfeed, she should inform her doctor before taking the medicine.

Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines

Trombex does not affect the ability to drive or operate machinery.

Trombex contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Trombex contains hydrogenated castor oil

May cause gastrointestinal discomfort or diarrhoea.

3. How to take Trombex

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

The recommended dose of Trombex is 75 mg once daily, taken orally at the same time each day, with or without food. This dose also applies to patients with a condition known as "atrial fibrillation" (irregular heartbeat).

If the patient has experienced severe chest pain (unstable angina or heart attack), the doctor may decide to initiate treatment with a single dose of 300 mg or 600 mg of Trombex (4 or 8 tablets of 75 mg). After this initial dose, the recommended dose of Trombex is one 75 mg tablet daily (as described above).

If the patient has experienced symptoms of stroke that resolve quickly (also known as transient ischaemic attack) or a mild stroke, the doctor may prescribe an initial single dose of 300 mg of Trombex (4 tablets of 75 mg). Afterwards, the recommended dose is one tablet of Trombex 75 mg daily, as described above, together with acetylsalicylic acid for 3 weeks. After this period, the doctor may prescribe Trombex or acetylsalicylic acid separately.

Trombex should be taken for as long as your doctor recommends.

Taking more Trombex than recommended
If you take more Trombex than you should, contact your doctor or the nearest hospital emergency department immediately due to an increased risk of bleeding.

If you forget to take Trombex
If you forget to take your Trombex tablet but remember within 12 hours of your usual dosing time, take the missed dose as soon as possible, then take the next dose at the usual time.
If more than 12 hours have passed, simply take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

For packages containing 7, 14, 28, and 84 tablets, two types of blister packs may be available (i.e. with or without a calendar printed on the blister).

Stopping Trombex treatment
Do not stop treatment unless instructed by your doctor. Consult your doctor or pharmacist before stopping treatment.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should contact your doctor immediately if you experience:
fever, signs of infection, or feeling extremely tired. This may be due to a rare reduction 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 appearing under the skin as red, pinpoint spots and/or confusion (see section 2 "Warnings and precautions").
swelling in the mouth or skin disorders such as: rash, itching, skin blisters. These may be symptoms of an allergic reaction.

The most common adverse effect reported during treatment with clopidogrel (the active substance in Trombex) is bleeding.
Bleeding may occur as gastrointestinal bleeding, bruising, haematomas (unusual bleeding or bruising under the skin), nosebleeds, or blood in the urine. In rare cases, bleeding inside the eye, head, lungs, or joints has also been reported.

If prolonged bleeding occurs while taking Trombex
When cut or injured, bleeding may last longer than usual. This is related to the mechanism of action of the medicine, as it prevents the formation of blood clots.
For minor cuts or wounds, e.g. a shaving cut or small laceration, this is usually not significant. However, if concerning bleeding occurs, you should contact your doctor immediately (see section 2 "Warnings and precautions").

Other adverse effects
Common (may affect up to 1 in 10 patients):
diarrhoea, abdominal pain, indigestion or heartburn.

Uncommon (may affect up to 1 in 100 patients):
headache, gastric ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, rash, itching, dizziness, tingling or numbness.

Rare (may affect up to 1 in 1,000 patients):
vertigo, gynaecomastia (enlargement of the breasts in males).

Very rare (may affect up to 1 in 10,000 patients):
jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes accompanied by cough; generalized allergic reaction, e.g. general feeling of warmth with sudden general discomfort, possibly leading to fainting; swelling of the lips; skin blisters; skin allergic reaction; oral pain (stomatitis); low blood pressure; confusion; hallucinations; joint pain; muscle pain; taste disturbances or loss of taste.

Adverse effects with unknown frequency (frequency cannot be estimated from available data):
Hypersensitivity reactions with chest pain or abdominal pain, persistent symptoms of low blood sugar.
Additionally, your doctor may detect changes in blood or urine test results.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Poland.
Tel: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.
Adverse effects can also be reported to the marketing authorisation holder or its representative in Poland.

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and on the
blister pack after "(EXP):". The expiry date refers to the last day of the stated month.
Glass bottle
Store in the original packaging to protect from moisture.
After first opening, store below 25°C and use within 3 months.
PVC/PVDC/Aluminium blister
Store in the original packaging to protect from moisture.
Store below 30°C.
Do not use this medicine if you notice any signs of deterioration.
Medicines should not be disposed of via wastewater or household waste bins. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

Brown glass bottle with HDPE cap and a moisture-absorbing insert
Pack sizes: 28, 30, 90 coated tablets.
PVC/PVDC/Aluminium blister
Pack sizes: 7, 14, 28, 30, 84, 90, 100 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 et 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 medicinal product is authorised for sale 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 further information about this medicinal product, please contact:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00