EZERO 20 mg / 10 mg
| EZERO 20 mg / 10 mg |
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Composition Rosuvastatin calcium eq. Rosuvastatin Ezetimibe |
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Product Category Lipid Regulator |
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Indications ROSUVASTATIN/EZETIMIBE fixed dose combination is indicated as adjunct to diet for treatment of primary hypercholesterolemia as substitution therapy in adult patients adequately controlled with the individual substances given concurrently at the same dose level as in the fixed dose combination, but as separate products. ROSUVASTATIN/ EZETIMIBE fixed dose combination should not be used as initial therapy. |
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Dosage and Administration Rosuvastatin/Ezetimibe should be taken at the same time every day, with or without food. The coated tablets are swallowed whole with a glass of water. |
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Contraindications Hypersensitivity to the active substances (Rosuvastatin, Ezetimibe) or to any of the excipients used in the proposed formulation. Active liver disease includes unexplained, persistent elevation of serum transaminases and any serum transaminase elevation exceeding 3 x the upper limit of normal (ULN). Pregnancy, breast – feeding and women of childbearing potential not using appropriate contraceptive measures. Sever renal impairment (creatinine clearance <30ml/min), patient with myopathy, patient receiving concomitant ciclosporin |
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Adverse Drug Reactions Common side effects (may occur in up to 1 in 10 people): Headache, constipation, feeling sick, muscle pain, feeling weak, dizziness, diabetes (patient may have high levels of sugar and fat in the blood, be overweight and have high blood pressure) abdominal pain diarrhea, flatulence (excess gas in the intestinal tract), feeling tired, elevation in some laboratory blood tests for liver function (transaminases).Storage STORE BELOW 30o c |
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Packaging and Registration Number EZERO® tablet salut selaput 20/10 mg; Dus, 3 blister @ 10 tablet salut selaput |