Hos patienter med svær nyreinsufficiens (creatinin clearance < 30 ml/ min) bør doseringer over 10 mg/ dag kun gives efter nøje overvejelse, og hvis det anses for nødvendigt, skal det implementeres med forsigtighed.
The MAH was requested to propose and scientifically justify a common EU wide approach as the contraindications text was considered to differ to a large extent between Member States especially relating to the use in patients with: • porphyria, • myopathy, • concomitant use of other medicinal products interacting with simvastatin, • biliary cirrhosis, • secondary hypercholesterolemia (hypothyroidism, nephrotic syndrome).