देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ROSUVASTATIN CALCIUM
HOVID BERHAD
ROSUVASTATIN CALCIUM
10tablet Tablets; 30tablet Tablets; 100tablet Tablets
HOVID BERHAD
_Consumer Medication Information Leaflet (RiMUP) _ HOVID-ROSUVASTATIN TABLET Rosuvastatin (20mg) 1 What is in this leaflet 1. What hovid-Rosuvastatin Tablet is used for 2. How Rosuvastatin Tablet works 3. Before you use hovid- Rosuvastatin Tablet 4. How to use hovid-Rosuvastatin Tablet 5. While you are using hovid- Rosuvastatin Tablet 6. Side effects 7. Storage and Disposal of hovid- Rosuvastatin Tablet 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision What hovid- Rosuvastatin Tablet is used for hovid-Rosuvastatin Tablet is used: To lower level of cholesterol. To prevent heart disease. When response to diet and exercise alone has been inadequate. How hovid-Rosuvastatin Tablet works This medicine contains rosuvastatin as the active ingredient. Rosuvastatin blocks an enzyme in the liver causing the liver to make less cholesterol, and rosuvastatin increases the uptake and breakdown by the liver of cholesterol already in the blood. Before you use hovid-Rosuvastatin Tablet _- When you must not use it _ _ _ Do not take this medicine if: you are hypersensitive to any of the ingredients listed at the end of this leaflet. you have liver disease you have kidney disease you have muscular disease you are using cyclosporine you are pregnant, trying to get pregnant or think you are pregnant. you are breastfeeding. If you are not sure whether you should start taking this medicine, talk to your pharmacist or doctor. _- Before you start to use it _ _ _ Tell your doctor if: you have your creatine kinase measurement you have hypothyroidism you consumed alcohol you are aging more than 70 years old your plasma level increases you have or with previous history of muscular problem you have liver problem you have lactose intolerance you have interstitial lung disease you have diabetes you are pregnant, trying to get pregnant or think you are pregnant. you are breastfeeding. _- Taking other medicines _ _ _ hovid-R पूरा दस्तावेज़ पढ़ें
HOVID-ROSUVASTATIN TABLET VIROS04-0 (MY) - renal impairment - hypothyroidism - personal or family history of hereditary muscular disorders - previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate - alcohol abuse - age >70 years - situations where an increase in plasma levels may occur - concomitant use of fibrates. In such patients the risk of treatment should be considered in relation to possible benefit and clinical monitoring is recommended. If CK levels are significantly elevated at baseline (>5xULN) treatment should not be started. • _WHILST ON TREATMENT:_ Patients should be asked to report inexplicable muscle pain, weakness or cramps immediately, particularly if associated with malaise or fever. CK levels should be measured in these patients. Therapy should be discontinued if CK levels are markedly elevated (>5xULN) or if muscular symptoms are severe and cause daily discomfort (even if CK levels are ≤ 5x ULN). If symptoms resolve and CK levels return to normal, then consideration should be given to re-introducing rosuvastatin or an alternative HMG-CoA reductase inhibitor at the lowest dose with close monitoring. Routine monitoring of CK levels in asymptomatic patients is not warranted. There have been very rare reports of an immune-mediated necrotising myopathy (IMNM) during or after treatment with statins, including rosuvastatin. IMNM is clinically characterised by proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment. An increase in the incidence of myositis and myopathy has been seen in patients receiving other HMG-CoA reductase inhibitors together with fibric acid derivatives including gemfibrozil, ciclosporin, nicotinic acid, azole antifungals, protease inhibitors and macrolide antibiotics. Gemfibrozil increases the risk of myopathy when given concomitantly with some HMG-CoA reductase inhibitors. Therefore, the combination of rosuvastatin and gemfibrozil is not recommended. The benefit of further alt पूरा दस्तावेज़ पढ़ें