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HSA Approval

DONEPEZIL MEVON FILM-COATED TABLETS 10 MG

SIN14811P

DONEPEZIL MEVON FILM-COATED TABLETS 10 MG

DONEPEZIL MEVON FILM-COATED TABLETS 10 MG

July 15, 2015

NOVEM PHARMA PRIVATE LIMITED

NOVEM PHARMA PRIVATE LIMITED

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantNOVEM PHARMA PRIVATE LIMITED
Licence HolderNOVEM PHARMA PRIVATE LIMITED

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

TABLET, FILM COATED

**4.2 Posology and method of administration** Adults/Elderly The treatment begins with 5mg/day (single daily dose). The 5mg/day dose must be kept for at least one month so that the initial response to the treatment may be assessed and the donepezil hydrochloride concentrations in the equilibrium state may be achieved. After 4–6 weeks clinical assessment of the 5mg/day one-month treatment, the dosage of Donepezil may be increased to 10mg/day (single daily dose). After discontinuation of the treatment, a gradual reduction in the beneficial effects of Donepezil is observed. There is no evidence of a rebound effect after abrupt discontinuation of therapy. Hepatic and renal failure A similar posology may be adopted for patients with renal failure, since clearance of donepezil hydrochloride is not affected by this condition. Due to the possible exposition increase in patients suffering from mild to moderate hepatic failure (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_), dose escalation must be prescribed according to the tolerability of individual patients. There is no information available for patients with severe hepatic failure. Children: The use of Donepezil is not recommended for children.

ORAL

Medical Information

**4.1 Therapeutic indications** Donepezil Mevon tablets are indicated for the symptomatic treatment of mild to moderate and severe Alzheimer’s dementia.

**4.3 Contraindications** Donepezil is contraindicated in patients with known hypersensitivity to donepezil hydrochloride, piperidine derivatives, or to any of the excipients used in the formula. Donepezil is contraindicated in pregnancy.

N06DA02

donepezil

Manufacturer Information

NOVEM PHARMA PRIVATE LIMITED

West Pharma – Produções de Especialidades Farmacêuticas, S.A.

Atlantic Pharma – Produções Farmacêuticas, S.A.

Active Ingredients

Donepezil 9.12mg eqv to Donepezil Hydrochloride

10 mg

Donepezil

Documents

Package Inserts

Donepezil Mevon FCT PI.pdf

Approved: December 2, 2022

Download

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DONEPEZIL MEVON FILM-COATED TABLETS 10 MG - HSA Approval | MedPath