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DONEPEZIL MEVON FILM-COATED TABLETS 5 MG [SIN14810P]
Active ingredients: DONEPEZIL MEVON FILM-COATED TABLETS 5 MG
Last updated 26 October 2025
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Product Info
DONEPEZIL MEVON FILM-COATED TABLETS 5 MG
[SIN14810P]
Product information
Active Ingredient and Strength | DONEPEZIL 4.56 MG EQV TO DONEPEZIL HYDROCHLORIDE - 5 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | ATLANTIC PHARMA - PRODUÇÕES FARMACÊUTICAS, S.A. - PORTUGAL |
Registration Number | SIN14810P |
Licence Holder | NOVEM PHARMA PRIVATE LIMITED |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | N06DA02 |
4.1 Therapeutic indications
Donepezil Mevon tablets are indicated for the symptomatic treatment of mild to moderate and severe Alzheimer’s dementia.
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.
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.