ARICEPT TABLET 5 mg

Nchi: Singapoo

Lugha: Kiingereza

Chanzo: HSA (Health Sciences Authority)

Viambatanisho vya kazi:

DONEPEZIL HCl EQV DONEPEZIL

Inapatikana kutoka:

EISAI (SINGAPORE) PTE. LTD.

ATC kanuni:

N06DA02

Kipimo:

5 mg

Dawa fomu:

TABLET, FILM COATED

Tungo:

DONEPEZIL HCl EQV DONEPEZIL 5 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

Prescription Only

Viwandani na:

EISAI TAIWAN INC

Idhini hali ya:

ACTIVE

Idhini ya tarehe:

1998-08-31

Taarifa za kipeperushi

1. NAME OF THE MEDICINAL PRODUCT
ARICEPT
® 
5 mg (donepezil hydrochloride)
ARICEPT
® 
10 mg (donepezil hydrochloride)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
5 mg donepezil hydrochloride tablets each containing 4.56 mg donepezil free 
base.
10 mg donepezil hydrochloride tablets each containing 9.12 mg donepezil free 
base.
3. PHARMACEUTICAL FORM
Film-coated tablets
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ARICEPT tablets are indicated for the symptomatic treatment of mild to 
moderate and severe Alzheimer’s dementia.
Special warnings and precautions for use in this indication may be found in 
Section 4.4.
4.2  POSOLOGY AND METHOD OF ADMINISTRATION 
ADULTS/ELDERLY:
Treatment is initiated at 5 mg/day (once-a-day dosing).  ARICEPT should be 
taken orally, in the evening, just prior to retiring. 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 a one-month clinical 
assessment of treatment at 5 mg/day, the dose of ARICEPT can be increased 
to 10 mg/day (once-a-day dosing). The maximum recommended daily dose is 
10 mg. Doses greater than 10 mg/day have not been studied in clinical
trials.
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 or mild to 
moderate hepatic impairment, as clearance of donepezil hydrochloride is not 
affected by these conditions.
CHILDREN:
ARICEPT is not recommended for use in children.
4.3 CONTRAINDICATIONS
ARICEPT is contraindicated in patients with a known hypersensitivity