Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product 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
Documents
Package Inserts
Donepezil Mevon FCT PI.pdf
Approved: December 2, 2022