EZETIMIBE MEVON TABLET 10 MG

TABLET

**4.2. Posology and method of administration** Posology The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with Ezetimibe MEVON. The recommended dose is one Ezetimibe MEVON 10 mg tablet daily. When Ezetimibe MEVON is added to a statin, either the indicated usual initial dose of that particular statin or the already established higher statin dose should be continued. In this setting, the dosage instructions for that particular statin should be consulted. _Co-administration with bile acid sequestrants_ Dosing of Ezetimibe MEVON should occur either ≥ 2 hours before or ≥ 4 hours after administration of a bile acid sequestrant. _Elderly_ No dosage adjustment is required for elderly patients (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Paediatric population_ Initiation of treatment must be performed under review of a specialist. Children and adolescents ≥ 10 years: No dosage adjustment is required. Children < 10 years: Treatment with ezetimibe is not recommended. _Hepatic impairment_ No dosage adjustment is required in patients with mild hepatic impairment (Child-Pugh score 5 to 6). Treatment with Ezetimibe MEVON is not recommended in patients with moderate (Child-Pugh score 7 to 9) or severe (Child-Pugh score > 9) liver dysfunction (see sections 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Renal impairment_ Monotherapy In patients with renal impairment, no dosage adjustment of ezetimibe is necessary (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Combination therapy with simvastatin In patients with mild renal impairment (estimated GFR ≥60 mL/min/1.73 m2), no dosage adjustment of ezetimibe or simvastatin is necessary. In patients with chronic kidney disease and estimated glomerular filtration rate <60 mL/min/1.73m2, the dose of ezetimibe is 10 mg and the dose of simvastatin is 20 mg once a day in the evening. In such patients, the use of higher doses of simvastatin should be closely monitored. Method of administration Route of administration is oral. Ezetimibe MEVON can be administered at any time of the day, with or without food.