1. Generic Name
    Clopidogrel 75mg tablet ,USP

    Dosage Form
    film coated tablet

    Strength and Dosage
    75 mg

    Therapeutic Category
    Cardiovascular – Antiplatelet

    Product Description


    Clopidogrel 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 blood clots forming (a process called thrombosis). Clopidogrel is taken to prevent blood clots (thrombi) forming 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 Clopidogrel to help prevent blood clots and reduce the risk of these severe events because:
    – You have a condition of hardening of arteries (also known as atherosclerosis), and
    – You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or
    – You have experienced a severe type of chest pain known as ‘unstable 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 should also 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 have an irregular heartbeat, a condition called ‘atrial fibrillation’, and you cannot take medicines known as ‘oral anticoagulants’ (vitamin K antagonists) which prevent new clots from forming and prevent existing clots from growing. You should have been told that ‘oral anticoagulants’ are more effective than acetylsalicylic acid or the combined use of Clopidogrel and acetylsalicylic acid for this condition. Your doctor should have prescribed Clopidogrel plus acetylsalicylic acid if you cannot take ‘oral anticoagulants’ and you do not have a risk of major bleeding.

    Do not take Clopidogrel
    – 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 if you are in any doubt at all, consult your doctor before taking Clopidogrel.


    WARNINGS AND PRECAUTIONS
    If any of the situations mentioned below apply to you, talk to your doctor or pharmacist or nurse before taking Clopidogrel
    – 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 inside any tissues, organs or joints of your body).
    – A recent serious injury.
    – A recent surgery (including dental).
    – A planned surgery (including dental) in the next seven days.

    HOW TO TAKE CLOPIDOGREL
    Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist or nurse has told you. Check with your doctor or pharmacist or nurse if you are not sure. If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of clopidogrel (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment. Then, the usual dose is one 75-mg tablet of Clopidogrel per day to be taken orally with or without food, and
    at the same time each day.
    You should take Clopidogrel for as long as your doctor continues to prescribe it.
    If you take more Clopidogrel than you should
    Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
    If you forget to take Clopidogrel
    If you forget to take a dose of Clopidogrel, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet 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 for the forgotten individual doses.
    If you stop taking Clopidogrel.
    Do not stop the treatment unless your doctor tells you so. Contact your doctor or pharmacist before stopping.

    If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.
    Like all medicines, this medicine can cause side effects, although not everybody gets them.
    The frequency of possible side effects listed below is defined using the following convention:
    • Very common (affects more than 1 user in 10)
    • Common (affects 1 to 10 users in 100)
    • Uncommon (affects 1 to 10 users in 1,000)
    • Rare (affects 1 to 10 users in 10,000)
    • Very rare (affects less than 1 user in 10,000)
    • Not known (frequency cannot be estimated from the available data)
    Contact your doctor immediately if you experience:
    – Fever, signs of infection or extreme tiredness. These may be due to rare decrease of some blood cells.
    – Signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 `Warnings and precautions’).
    – Swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin. These may be the signs of an allergic reaction.

    The most common side effect reported with clopidogrel is bleeding.
    Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), 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.
    If you experience prolonged bleeding when taking Clopidogrel
    If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is linked to the way your medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern. However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Warnings and precautions’).


    POSSIBLE SIDE EFFECTS
    In addition, your doctor may identify changes in your blood or urine test results. If you get any side effects, talk to your doctor or pharmacist or nurse.

    HOW TO STORE CLOPIDOGREL
    Keep this medicine out of the sight and reach of children.
    Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
    Store below 30C.
    HDPE bottle pack: Use within 6 months after first opening the HDPE bottle.
    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

    Contents of the pack and other information
    What Clopidogrel contains
    – The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as clopidogrel bisulfate).
    – The other ingredients are microcrystalline cellulose (grade 113), mannitol, low substituted hydroxypropylcellulose, crospovidone (type A), macrogol 6000, hydrogenated castor oil, lactose monohydrate, hypromellose (15 cp), titanium dioxide (E171), triacetin, iron oxide red (E172).
    What Clopidogrel looks like and contents of the pack
    Film-coated tablet.
    Pink coloured, round, biconvex, bevel edge, film-coated tablets, plain on both side.
    Clopidogrel 75 mg film-coated tablets are available in PVC/ Aclar/ Aluminium blister packs containing 14, 28, 30, 50, 56, 84, 100 & 500 film-coated tablets and HDPE bottle packs containing 30 or 100 film-coated tablets.
    Important Disclaimer: The drug information provided here is for educational purposes only. It is intended to supplement, not substitute for, the diagnosis, treatment and advice of a medical professional. This drug information does not cover all possible uses, precautions, side effects and interactions. It should not be construed to indicate that this or any drug is safe for you. Consult your medical professional for guidance before using any prescription or over the counter drugs.

    Note : This product information is intended only for residents of the India. Taj Pharmaceuticals Limited,  medicines help to treat and prevent a range of conditions—from the most common to the most challenging—for people around the world.

    Information for Health Care Professionals

    *** Please consult local Prescribing Information for any product before use. This website is an international information resource for healthcare professionals with an interest in disease management. This website is not intended to replace the advice of a qualified healthcare professional. Above brand is a trademark of the Taj group of companies (Taj Pharmaceuticals Limited).
    *The photos shown are samples only. Not all photos of the drug may be displayed. Your medication may look different. If you have questions, ask your pharmacist.
    Important note
    HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

    Information last revised July 2014. Copyright(c) 2014 Taj Pharma.
    Selected from General Medical Drug data included with permission.

    The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.









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