ARICEPT FILM-COATED TABLETS 23MG [SIN14575P]

Product Info

ARICEPT FILM-COATED TABLETS 23MG

[SIN14575P]

4.1 Therapeutic indication
ARICEPT® is indicated for the symptomatic treatment of mild to moderate and severe Alzheimer's dementia. ARICEPT® Film-coated Tablet 23mg should only be administered to patients whose condition is not adequately controlled by a lower dose of donepezil hydrochloride 10mg.

4.2 Posology and method of administration

Adults/Elderly:
Treatment is initiated at 5 mg/day (once-a-day dosing). The 5 mg/day dose should be maintained for at least one month in order to allow the earliest clinical responses to treatment to be assessed and to allow steady-state concentrations of donepezil hydrochloride to be achieved. Following 4–6 weeks clinical assessment of treatment at 5 mg/day, the dose of ARICEPT® can be increased to 10 mg/day (once-a-day dosing). If well tolerated and after being stabilized on a daily dose of 10 mg for at least 3 months, the dose may be increased to 23mg (given as one ARICEPT® Film-coated Tablet 23 mg) once daily in patients whose condition is not adequately controlled. ARICEPT® EVESS Tablets should be taken orally, in the evening, just prior to retiring. The tablet should be placed on the tongue and allowed to disintegrate before swallowing with or without water, according to patient preference. ARICEPT® Film-coated Tablets can be taken once daily in the evening just prior to retiring and can be taken with or without food. ARICEPT® Film-coated Tablets 23 mg should not be split or crushed and should be swallowed whole with water.
Upon discontinuation of treatment, a gradual abatement of the beneficial effects of ARICEPT® is seen. There is no evidence of a rebound effect after abrupt discontinuation of therapy.

Renal and hepatic impairment:
A similar dose schedule can be followed for patients with renal impairment as clearance of donepezil hydrochloride is not affected by this condition.
Due to possible increased exposure in mild to moderate hepatic impairment, dose escalation should be performed according to individual tolerability. There are no data for patients with severe hepatic impairment.

Children:
ARICEPT® is not recommended for use in children.

4.3 Contraindications
ARICEPT® is contraindicated in patients with a known hypersensitivity to donepezil hydrochloride, piperidine derivatives, or to any excipients used in the formulation. ARICEPT® is contraindicated in pregnancy.