TROMBEX 75 mg. 30 tablets
Trombex, belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small structures in the blood, which clump together during blood clots by preventing this clumping, antiplatelet medicinal products reduce the risk of blood clots forming (a process called thrombosis).
Trombex be taken to prevent blood clots (thrombi) in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
You have been prescribed Trombex to prevent blood clots and reduce the risk of these severe events because:
- You have a condition of hardening of arteries (also known as atherosclerosis), or
- You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or
- You have experienced severe chest pain »inestabilna condition known as angina 'or' myocardial infarction '(heart attack). For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow. You may be given acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor. you irregular heartbeat, a condition called 'atrial fibrillation', and you can not take medicines known as 'oral anticoagulants' (vitamin K antagonists) which prevent the formation and growth of blood clots. You should know that oral anticoagulants are more effective than acetylsalicylic acid or the combined use of Trombex and acetylsalicylic acid for this condition. Your doctor should prescribe Trombex acetylsalicylic acid if you can not take 'oral anticoagulants' and you there is no risk of major bleeding.
2. What you need to know before you take Trombex?
Do not take Trombex:
• If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine (listed in section 6);
• If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain;
• If you suffer from severe liver disease.
If you think any of these apply to you, or you have any doubts, consult your doctor before taking Trombex.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Trombex:
• if you have a risk of bleeding such as
- A medical condition that puts you at risk of internal bleeding (such as a stomach ulcer) a blood disorder that makes you prone to internal bleeding (bleeding in the tissues, organs or joints of your body) recent serious injury recent surgery (including dental) planned surgery (including dental) in the next
• If you have had a clot in an artery of your brain (ischemic stroke) which occurred within the last seven days
• if you have kidney or liver disease.
During the use of Trombex:
• You should tell your doctor if a surgery (including dental).
• You should also immediately inform your doctor if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion yellowing of skin or eyes (jaundice) (see section 4 "POSSIBLE SIDE EFFECTS").
• If you cut or injure yourself, it may take a little longer than usual to stop bleeding. This is related to the mode of action of the drug to prevent the formation of blood clots. For minor cuts and injuries eg. cutting yourself shaving, this is usually of no concern. However, if the bleeding you are worried, you should contact your doctor immediately (see section 4 "POSSIBLE SIDE EFFECTS").
• Your doctor may order blood tests.
Trombex is not intended for use by children and adolescents.
Other medicines and Trombex
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Some medicines may influence the use of Trombex and vice versa.
You should inform your doctor if you take oral anticoagulants, medicines used to reduce blood clotting, nonsteroidal anti-inflammatory drugs commonly used to treat painful and / or inflammatory conditions of muscles or joints, heparin or any other injectable medicine for reduce blood clotting, omeprazole, esomeprazole or cimetidine, drugs used for the treatment of upset stomach, fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines for the treatment of bacterial fungal infections etc., fluoxetine, fluvoxamine or moclobemide, medicines for the treatment of depression, carbamazepine or oxcarbazepine, medicines for the treatment of certain forms of epilepsy, ticlopidine, other antiplatelet agent.
If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Trombex in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever. An occasional use of acetylsalicylic acid (no more than 1000 mg per 24 hours) would not be a problem, but prolonged use in other circumstances should be discussed with your doctor.
Taking Trombex with food and drink
Trombex can be taken with or without food.
Pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, talk to your doctor before taking this medicine.
It is preferable not to take this medicine during pregnancy. If you are pregnant or suspect that you are pregnant, you should tell your doctor or pharmacist before taking Trombex. If you become pregnant while taking Trombex immediately consult your doctor, because it is not recommended for use clopidogrel during pregnancy.
You should not breast-feed while taking this medicine. If you are breastfeeding or planning to breastfeed, talk to your doctor before taking this medicine.
Driving and using machines
Trombex is unlikely to affect your ability to drive or use machines. Important information about some of the ingredients of Trombex:
Trombex contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (eg. Lactose), contact him before taking this medicine.
Trombex also contains hydrogenated castor oil which may cause stomach upset or diarrhea.
3. How to take Trombex?
Always take this medicine exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg Trombex (4 tablets of 75 mg) once at the start of treatment. Then, the usual dose is one 75 mg tablet of Trombex per day to be taken orally with or without food, and at the same time each day.
You should take Plavix for as long as your doctor prescribes it. If you take more dose Trombex
Contact your doctor or go to the emergency department at the nearest hospital because of the increased risk of bleeding.
If you forget to take Trombex
If you forget to take a dose Trombex, but remember within 12 hours of your usual time, take your tablet immediately and then take the next one at the usual time.
If you forget for more than 12 hours, simply take the next single dose at the usual time. Do not take a double dose to make up the missed dose. In packs of 7, 14, 28 and 84 tablets, you can check the day on which you last took a tablet Trombex a calendar printed on the blister.
If you stop taking Trombex
Do not stop treatment unless your doctor tells you. Contact your doctor or pharmacist before you do.
If you have any further questions on the use of this product, ask your doctor or pharmacist
4. Possible side effects
Like all medicines, Trombex can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience:
fever, signs of infection or extreme tiredness. They may be due to: a rare decrease of some blood cells, signs of liver problems such as yellowing of the skin and / or eyes (jaundice), whether or not associated with bleeding which occur as small red spots and / or confusion (see section 2 ** Warnings and precautions "), swelling of the mouth or skin disorders such as rashes and itching, blisters of the skin. These may be symptoms of an allergic reaction.
The most common adverse reactions (occurring in 1 to 10 patients in 100) reported for clopidogrel (the active substance of the medicinal product Trombex) is bleeding. Bleeding may occur as bleeding in the stomach or bowels, bruising, hematoma (unusual bleeding or bruising under the skin), nose bleed, blood in the urine. In a few cases also reported bleeding in the eye, skull, lung or joints.
If you experience prolonged bleeding when taking Trombex
If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is related to the mode of action of the drug to prevent the formation of blood clots. For minor cuts and injuries eg. cutting yourself shaving, this is irrelevant. However, if the bleeding you are worried, you should contact your doctor immediately (see section 2 "Warnings and precautions").
Other side effects reported with clopidogrel (the active substance of the medicinal product Trombex) are:
Common side effects (affects 1 to 10 patients in 100): diarrhea, abdominal pain, indigestion or heartburn.
Uncommon side effects (affects 1 to 10 patients in 1,000): Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in the stomach or intestines, rashes, itching, dizziness, numbness and tingling.
Rare side effects (affects 1 to 10 patients in 10,000): Vertigo
Very rare side effects (affecting less than 1 patient in 10,000): jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalized allergic reactions; swelling of the mouth; blisters of the skin; Allergic skin reactions; inflammation of the mouth (stomatitis); lowering blood pressure; confusion; hallucinations; joint pain; muscle pain; dysgeusia.
In addition, your doctor may identify changes in your ^ of blood and urine.
If you get any side effects, tell your doctor or pharmacist. This includes any possible effects not listed in this leaflet.
5. How to store Trombex?
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP 55. The expiry date refers to the last day of that month. Glass Bottle: Store in the original package to protect from moisture. After opening can be used within 3 months when stored below 25 ° C.
RUS / ur PC / Aluminium blister: Store below 30 ° C in the original package to protect from moisture.
Do not use Trombex if you notice visible signs of deterioration of the product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
The active ingredient is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate).
The other ingredients are mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000 and low-substituted hydroxypropylcellulose in the core, and lactose (milk sugar), hypromellose (E464), triacetin (1518), iron oxide red (E172), titanium dioxide (E171) and carnauba wax in the shell.
Trombex looks like and contents of the pack?
Trombex are round, biconvex, pink, film-coated tablets engraved with "75" on one side and the number "1171" on the other side. Trombex is supplied in cartons containing 7, 14, 28, 30, 84, 90 and 100 tablets in PVC / PVDC / aluminum blisters or 28, 30 and 90 tablets in brown glass bottles with white HDPE screw cap with a desiccant. Not all pack sizes may be marketed.