SIMVAZAF

*Primary hypercholesterolaemia, or combined (mixed) hyperlipidaemia:* Adult: 10-20 mg once daily at night, then increased if necessary up to 80 mg once daily, adjusted at intervals of at least 4 weeks, 80 mg dose only for those with severe hypercholesterolaemia and at high risk of cardiovascular events. Children 5-10 yrs: Initially 10 mg at night increased, if necessary, at intervals of at least 4 week to max 20 mg at night; 10-18 yrs: Initially 10 mg at night increased, if necessary, at intervals of at least 4 wk to max 40 mg at night. *Homozygous familial hypercholesterolaemia:* Adult: Initially 40 mg once daily at night, then increased if necessary up to 80 mg once daily, adjusted at intervals of at least 4 weeks, 80 mg dose only for those with severe hypercholesterolaemia and at high risk of cardiovascular events. *Prevention of cardiovascular events in patients with atherosclerotic cardiovascular disease or diabetes mellitus:* Adult: Initially 20-40 mg once daily at night, increased if necessary up to 80 mg once daily, adjusted at intervals of at least 4 weeks.

Active liver disease, pregnancy

Renal impairment, history of liver disease; perform liver function tests before and during treatment. Women must be protected by non-hormonal contraceptive methods

Digoxin, coumarin anticoagulants, cyclosporin, gemfibrozil and other fibrates, nicotinic acid, erythromycin, clarithromycin, macrolide antibiotics, azole antifungals, other CYP3A4 inhibitors, immunosuppressants, nefazodone, protease inhibitors, grapefruit juice.

Constipation, flatulence, headache, asthenia, nausea, dyspepsia, abdominal pain diarrhoea, rash, alopecia, dizziness, muscle cramps, myalgia, pancreatitis, paraesthesia, peripheral neuropathy, anaemia, hepatitis, jaundice. Rare: Rhabdomyolysis, myopathy; measure creatine phosphokinase levels; withdraw therapy if markedly raised.