EZETIMIBE MEVON TABLET 10 MG

Atlantic Pharma – Produções Farmacêuticas, S.A. (PORTUGAL)🇸🇬 Health Sciences Authority

Approval Date: Mar 8, 2022
Approval ID: 7541322d6307b437
Company: Atlantic Pharma – Produções Farmacêuticas, S.A. (PORTUGAL)
Type: Therapeutic

Approval Details

Approval Id: 7541322d6307b437
Drug Name: EZETIMIBE MEVON TABLET 10 MG
Product Name: EZETIMIBE MEVON TABLET 10 MG
Approval Number: SIN16441P
Approval Date: 2022-03-08
Registrant: NOVEM HEALTHCARE PTE LTD
Licence Holder: NOVEM HEALTHCARE PTE LTD
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: TABLET
Dosage: 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.
Route Of Administration: ORAL
Indication Info: 4.1. Therapeutic indications Primary Hypercholesterolaemia Ezetimibe MEVON co-administered with an HMG-CoA reductase inhibitor (statin) or alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C) and apolipoprotein B (Apo B) in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia. Homozygous Familial Hypercholesterolaemia (HoFH) Ezetimibe MEVON co-administered with atorvastatin or simvastatin, is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. Homozygous Sitosterolaemia (Phytosterolaemia) Ezetimibe MEVON is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.
Contraindications: 4.3. Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. When Ezetimibe MEVON is co-administered with a statin, please refer to the SmPC for that particular medicinal product. Therapy with Ezetimibe MEVON co-administered with a statin is contraindicated during pregnancy and lactation. Ezetimibe MEVON co-administered with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases.
Atc Code: C10AX09
Atc Item Name: ezetimibe
Pharma Manufacturer Name: NOVEM PHARMA PRIVATE LIMITED

Active Ingredients

Ezetimibe

10 mg

EZETIMIBE

10 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Mar 8, 2022

Approval ID

7541322d6307b437

Type

Therapeutic

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