PRESENTATION: 10 mg Tablet containing 10 mg of ezetimibe. USES: As adjunctive therapy to diet in: Primary hypercholesterolaemia: For co-administration with an HMG CoA reductase inhibitor (statin) for patients with primary (heterozygous familial and non-familial) hypercholesterolaemia not appropriately controlled with a statin alone. Monotherapy: For use in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia in whom a statin is considered inappropriate or is not tolerated. Homozygous Familial Hypercholesterolaemia (HoFH): For co-administration with a statin, for use in patients with HoFH. Patients may also receive adjunctive treatments (e.g. LDL apheresis). Homozygous sitosterolaemia (phytosterolaemia): For use in patients with homozygous familial sitosterolaemia. Studies to demonstrate the efficacy of 'Ezetrol' in the prevention of complications of atherosclerosis have not yet been completed. DOSAGE AND ADMINISTRATION: For oral administration: Put patients on an appropriate lipid lowering diet and continue during treatment. Recommended dose is one 'Ezetrol' 10 mg tablet daily, administered at any time of the day, with or without food. When added to a statin, either continue with the indicated usual initial dose of that particular statin or the already established higher statin dose. Consult the statin dosage instructions. Co-administration with bile acid sequestrants: Dosing should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant. Use in paediatric patients: Children <10 years: Not recommended as no clinical data are available. Use in hepatic impairment: No dosage adjustment is required with mild hepatic insufficiency (Child Pugh score 5 to 6). Not recommended in patients with moderate (Child Pugh score 7 to 9) or severe (Child Pugh score >9) liver dysfunction. CONTRA-INDICATIONS: Hypersensitivity to any component. When co-administered with a statin, refer to the statin SPC. 'Ezetrol' co-administered with a statin during pregnancy and lactation. 'Ezetrol' co-administered with a statin in patients with active liver disease or unexplained persistent elevations in serum transaminases. PRECAUTIONS: Liver enzymes: When co-administered with a statin, perform liver function tests at initiation of therapy and according to the statin SPC. Skeletal muscle: In post-marketing experience with 'Ezetrol', myopathy and rhabdomyolysis have been reported. Most patients who developed rhabdomyolysis were taking a statin concomitantly with 'Ezetrol'. However, rhabdomyolysis has been reported very rarely with 'Ezetrol' monotherapy and very rarely with the addition of 'Ezetrol' to other agents known to be associated with increased risk of rhabdomyolysis. If myopathy is suspected based on muscle symptoms or is confirmed by a creatinine phosphokinase (CPK) level >10 times the ULN, immediately discontinue 'Ezetrol', any statin, and any of these other agents. Advise all patients starting therapy with 'Ezetrol' of the risk of myopathy and to report promptly any unexpla...