The film-coated tablets are pink-coloured, round, biconvex, bevel-edged, and debossed with 'E' on one side and '34' on the other side.
Each film-coated tablet contains 75 mg of clopidogrel (as clopidogrel bisulfate).
Excipients/Inactive Ingredients: microcrystalline cellulose (grade 113), mannitol, low substituted hydroxypropylcellulose, crospovidone (type A), macrogol 6000, hydrogenated castor oil, lactose monohydrate (see Clopidogrel contains lactose under Precautions), hypromellose (15 cp), titanium dioxide (E171), triacetin, iron oxide red (E172).
Clopidogrel film-coated tablets contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small structures in the blood which clump together during blood clotting. By preventing this clumping, antiplatelet medicinal products reduce the chances of thrombosis.
Clopidogrel is taken by adults to prevent atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Clopidogrel has been prescribed to help prevent blood clots and reduce the risk of these severe events in: Patients who have atherosclerosis, and have previously experienced a heart attack, stroke or have peripheral arterial disease, or have experienced unstable angina or myocardial infarction. For the treatment of this condition, a stent may have been placed in the blocked or narrowed artery to restore effective blood flow. Acetylsalicylic acid may also be given.
Patients who have experienced symptoms of transient ischemic attack or mild ischemic stroke. Acetylsalicylic acid may also be given within the first 24 hours.
Patients who have atrial fibrillation and cannot take oral anticoagulants (vitamin K antagonists). Clopidogrel plus acetylsalicylic acid should have been prescribed if oral anticoagulants cannot be taken and there is no risk of major bleeding.
This medicine should always be taken exactly as prescribed.
The recommended dose, including for patients with atrial fibrillation, is one 75-mg tablet of Clopidogrel per day to be taken orally with or without food, and at the same time each day.
In case of severe chest pain (unstable angina or heart attack), 300 mg or 600 mg of Clopidogrel may be given once at the start of treatment. Then, the recommended dose is one 75-mg tablet of Clopidogrel per day as described previously.
In case of symptoms of transient ischemic attack or mild ischemic stroke, 300 mg of Clopidogrel may be given once at the start of treatment. Then, the recommended dose is one 75-mg tablet of Clopidogrel per day as described previously with acetylsalicylic acid for 3 weeks. Then, either Clopidogrel alone or acetylsalicylic acid alone would be prescribed.
Clopidogrel should be taken for as long as it is continued to be prescribed.
Forgotten intake of Clopidogrel: If a dose is forgotten but remembered within 12 hours of the usual intake time, the tablet should be taken straightaway and then the next tablet should be taken at the usual time.
If more than 12 hours have passed, the next single dose should be taken at the usual time. A double dose should not be taken to make up for a forgotten tablet.
Stopping intake of Clopidogrel: Treatment should not be stopped unless instructed to. Patients should seek medical attention before stopping.
The risk of bleeding is increased in patients who have taken more Clopidogrel than they should.
Clopidogrel should not be taken by: patients who are allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine (listed in Description); patients who have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain; patients who suffer from severe liver disease.
Before taking Clopidogrel: Use with caution in: patients who have a risk of bleeding [such as stomach ulcer, blood disorder with risk of internal bleeding, recent serious injury, recent surgery (including dental), planned surgery (including dental) in the next seven days]; patients who have had ischemic stroke within the last seven days; patients who have kidney or liver disease; patients who have had an allergy or reaction to any medicine; patients who had a past medical history of non-traumatic brain hemorrhage.
While taking Clopidogrel: Use with caution in: patients who have a planned surgery (including dental); patients who develop thrombotic thrombocytopenic purpura (TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, jaundice (see Side Effects).
In case of cuts or injuries, it may take longer than usual for bleeding to stop. This is linked to the way the medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries e.g., cutting oneself, shaving, this is usually of no concern. However, if the bleeding is concerning, patients should seek medical attention straightaway (see Side Effects).
Blood tests may be ordered.
Clopidogrel contains lactose: Patients who have an intolerance to some sugars should seek medical attention before taking this medicinal product.
Clopidogrel contains hydrogenated castor oil: This may cause stomach upset or diarrhoea.
Driving and using machines: Clopidogrel is unlikely to affect the ability to drive or to use machines.
Use in Children: This medicine should not be given to children because it does not work.
It is preferable not to take this product during pregnancy.
In case of confirmed or suspected pregnancy, patients should seek medical attention before taking Clopidogrel. If pregnancy occurs while taking Clopidogrel, patients should seek medical attention immediately as it is recommended not to take clopidogrel while pregnant.
Patients should not breast-feed while taking this medicine.
Patients who are breast-feeding or planning to breast-feed should seek medical attention before taking this medicine.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediate medical attention: Patients should seek medical attention immediately if the following are experienced: fever, signs of infection or extreme tiredness; signs of liver problems such as jaundice, whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see Precautions); swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin.
Bleeding: The most common side effect reported with clopidogrel is bleeding. Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma, nose bleed, blood in the urine. In a small number of cases, bleeding in the eye, inside the head, the lung or the joints has also been reported.
Prolonged bleeding when taking Clopidogrel: In case of cuts or injuries, it may take longer than usual for bleeding to stop. This is linked to the way the medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries e.g., cutting oneself, shaving, this is usually of no concern. However, if the bleeding is concerning, patients should seek medical attention straightaway (see Precautions).
Other side effects: Common side effects (may affect up to 1 in 10 people): Diarrhoea, abdominal pain, indigestion or heartburn.
Uncommon side effects (may affect up to 1 in 100 people): Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.
Rare side effects (may affect up to 1 in 1000 people): Vertigo, enlarged breasts in males.
Very rare side effects (may affect up to 1 in 10,000 people): Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; stomatitis; decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in taste or loss of taste of food.
Side effects with frequency not known (frequency cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain, persistent low blood sugar symptoms.
In addition, changes may be identified in the blood or urine test results.
Reporting of side effects: Side effects should be reported. This includes any possible side effects not previously listed. By reporting side effects, patients can help provide more information on the safety of this medicine.
Other medicines and Clopidogrel: Some other medicines may influence the use of Clopidogrel or vice versa.
Use with caution in patients who take: medicines that may increase the risk of bleeding [such as oral anticoagulants, non-steroidal anti-inflammatory medicine, heparin or any other injectable medicine used to reduce blood clotting, ticlopidine, selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), rifampicin]; omeprazole or esomeprazole; fluconazole or voriconazole; efavirenz or other anti-retroviral medicines; carbamazepine; moclobemide; repaglinide; paclitaxel; opioids; rosuvastatin.
In case of severe chest pain (unstable angina or heart attack), transient ischemic attack or mild ischemic stroke, Clopidogrel may be prescribed in combination with acetylsalicylic acid. An occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24-hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed.
Clopidogrel with food and drink: Clopidogrel may be taken with or without food.
Medicines should not be thrown away via wastewater or household waste. Patients should be advised how to throw away medicines that are no longer used. These measures will help protect the environment.
B01AC04 - clopidogrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Clopidogrel Farmoz FC tab 75 mg
2 × 14's
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