EZOLETA TABLETS 10MG

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 Ezoleta. The recommended dose is one Ezoleta 10 mg tablet daily. Ezoleta can be administered at any time of the day, with or without food. When Ezoleta 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. Patients with Renal Impairment _Monotherapy_ In patients with renal impairment, no dosage adjustment of Ezoleta is necessary (see section 5.2, Special populations – _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 Ezoleta or simvastatin is necessary. In patients with chronic kidney disease and estimated glomerular filtration rate <60 mL/min/1.73 m2, the dose of Ezoleta 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. (See section 5.2, Special populations and section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Use in the Elderly No dosage adjustment is required for elderly patients (see section 5.2, Special populations – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Use in Pediatric Patients Children and adolescents ≥10 years: No dosage adjustment is required (see section 5.2, Special populations – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Children <10 years: Treatment with Ezoleta is not recommended. Use in Hepatic Impairment No dosage adjustment is required in patients with mild hepatic insufficiency (Child Pugh score 5 to 6). Treatment with ezetimibe 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, Special populations – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Co-administration with bile acid sequestrants Dosing of Ezoleta should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.