COPLAVIX Film-coated tablet (2022)
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Περιεχόμενα
Name of the medicinal product
Coplavix Film-coated tablet 75mg/100mg.
Qualitative and quantitative composition
Clopidogrel hydrogen sulphate 97.875 mg (molar equivalent of 75 mg of clopidogrel base) and 111.11 mg of acetylsalicylic acid granulated with maize-starch corresponding to 100 mg of acetylsalicylic acid ...
Pharmaceutical form
Film-coated tablet. CoPlavix tablets are light pink, oval, slightly biconvex, film-coated, engraved with «C75» on one side and «A100» on the other side.
Therapeutic indications
CoPlavix is indicated for the secondary prevention of atherothrombotic events in patients suffering from acute coronary syndrome: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Qwave ...
Posology and method of administration
Adults and elderly CoPlavix fixed dose combination (FDC) should be given as a single daily 75 mg/100 mg dose. CoPlavix FDC is used in adult patients already taking both clopidogrel and ASA given separately ...
Contraindications
Due to the presence of both components of the product, CoPlavix is contraindicated in case of: Hypersensitivity to either of the active substances or the excipients of the medicinal product. severe liver ...
Special warnings and precautions for use
Bleeding and haematological disorders Due to the risk of bleeding and haematological undesirable effects, blood cell count determination and/or other appropriate testing should be promptly considered whenever ...
Interaction with other medicinal products and other forms of interaction
<u>Drugs associated with bleeding risk:</u> There is an increased risk of bleeding due to the potential additive effect. The concomitant administration of drug associated with bleeding risk should be undertaken ...
Pregnancy and lactation
Pregnancy No clinical data on exposed pregnancies with CoPlavix are available, and no adequate data are available for clopidogrel alone. Animal studies have demonstrated a teratogenic effect arising from ...
Effects on ability to drive and use machines
CoPlavix has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Clinical studies experience Clopidogrel has been evaluated for safety in more than 42,000 patients, including over 30,000 patients treated with clopidogrel plus ASA, and over 9,000 patients treated for ...
Overdose
There is no information concerning overdosage with CoPlavix. <u>Clopidogrel:</u> Overdose following clopidogrel administration may lead to prolonged bleeding time and subsequent bleeding complications. ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> platelet aggregation inhibitors excl. Heparin <b>ATC Code:</b> B01AC30 Clopidogrel is a prodrug, one of whose metabolites is an inhibitor of platelet aggregation. Clopidogrel ...
Pharmacokinetic properties
Clopidogrel Absorption After single and repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed. Mean peak plasma levels of unchanged clopidogrel (approximately 2.2-2.5 ng/ml after a single ...
Preclinical safety data
Clopidogrel During non-clinical studies in rat and baboon, the most frequently observed effects were liver changes. These occurred at doses representing at least 25 times the exposure seen in humans receiving ...
List of excipients
<u>Core:</u> Mannitol (E421) Macrogol 6000 Microcrystalline cellulose (low water content, 90 mcm) Low substituted hydroxypropylcellulose Hydrogenated castor oil Stearic acid Anhydrous colloidal silica ...
Incompatibilities
Not applicable.
Shelf life
24 months.
Special precautions for storage
Store below 25°C. Store in the original package.
Nature and contents of container
14, 28, 30, 50, 84 and, 90, and 100 film-coated tablets packed in aluminium blister packs in cardboard cartons. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
SANOFI WINTHROP INDUSTRIE, 1, rue de la Vierge, Ambarès et Lagrave, 33565 Carbon Blanc cedex, France
Date of revision of the text
Aug 2021
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