COMPOSITION: Each hard gelatine capsule contains: Rosuvastatin calcium IP eq. to Rosuvastatin 10 mg (as granules), Aspirin IP (as enteric coated tablet) 75 mg, Clopidogrel Bisulphate IP eq. to Clopidogrel 75 mg (as two film coated tablets).
INDICATIONS: Maintenance therapy in the treatment of Acute Coronary Syndrome and ischaemic stroke.
ADVERSE REACTIONS: Headache, dizziness, nausea, vertigo, chest pain, GI disturbances, prolonged bleeding time, paraesthesia, rhinitis, muscle pain and urticaria.
CONTRA-INDICATIONS: Hypersensitivity to rosuvastatin, aspirin, clopidogrel or any other constituents listed in the formulation, active peptic ulcer disease, children <12 years, patients with haemorrhagic disorders, severe renal/hepatic impairment, lactation.
PRECAUTIONS: If CK levels are significantly elevated at baseline (>5xULN) treatment should not be started, prescribe with caution in patients with pre-disposing factors for myopathy/rhabdomyolysis, due to the risk of bleeding appropriate testing should be considered, should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
DOSAGE AND ADMINISTRATION: 1 capsule to be taken once daily after meal.
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