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Skeletal muscle effects: Effects on skeletal muscle e.g. myalgia, myopathey)including myositis ) and , rarely, rhabdomyolyiss have been reported in rosuvastatintreatedpatients with all doses and in particular with doses >20 mg.A dose –related increase in CK levels has been observed in patients takingrosuvastatin; the majority of cases were mild, asymptomatic and transient. If CKlevels are elevated (>5x ULN), treatment should be discontinued (see Specialwarnings and precautions for use).Liver effects :As with other HMG –CoA reductase inhibitors, a dose-related increase intransaminases has been observed in a small number of patients taking rosuvastatin;the majority of cases were mild, asymplomatic and transient .Post marketing experience :In addition to the above, the following adverse events have been reported during postmarketingexperience for rosuvastatin:Hepatobiliary disorders: very rare: jaundice, hepatitis; rare: increased hepatictransminases.Musculoskeletal disorders: Rare: arthralgia.Nervous system disorders: Very rare: polyneuropathy, memory loss.Renal disorders:Very rare :haematuriaThe reporting rates for rhabdomyolysis, serious renal events and serious hepaticevents (consisting mainly of increased hepatic transaminases ) is higher at the 40 mgdose.Effects on ability to drive and use machinesStudies to determine the effect of rosuvastatin on the ability to drive and use machineshave not been conducted. However, based on its pharmacodynamic properties,rosuvastatin is unlikely to affect this ability. When driving vehicles or operatingmachines, it should be taken into account that dizziness may occur during treatment.Warnings and PrecutionsRenal effectsProteinuria, detected by dipstick testing and mostly tubular in origin, has beenobserved in patients treated with higher doses of Eveness®, in particular 40 mg,where it was transient or intermittent in most cases. Proteinuria has not been shown tobe predictive of acute or progressive renal events in post-marketing use are higher atthe 40 mg dose. An assessment of renal function should be considered during routinefollow-up of patients treated with a dose of 40 mg.Skeletal muscle effectsEffects on skeletal muscle e.g. myalgia, myopathy and , rarely, rhabdomyolysis havebeen reported in Eveness® -treated patients with all doses and in particular with doses>20 mg. Very rare cases of rhabdomyolsis have been reported with the use ofezetimibe in combination with HMG-CoA reductase inhibitors, and caution should beexercised with their combined use .As with other HMG-CoA reductase inhibitors, the reporting rate for rhabdomyloysisassociated with rosuvastatin in post- marketing use is higher at the 40 mg dose.Creatine Kinase measurement

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