Donepezil

Country: Նոր Զելանդիա

language: անգլերեն

source: Medsafe (Medicines Safety Authority)

active_ingredient:

Donepezil hydrochloride 10mg

MAH:

REX Medical Ltd

INN:

Donepezil hydrochloride 10 mg

dosage:

10 mg

pharmaceutical_form:

Film coated tablet

composition:

Active: Donepezil hydrochloride 10mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry yellow 04F52201 Purified water Starch

units_in_package:

Blister pack, PVC/PE/PVDC/AI, 10 tablets per blister strip, Sample pack, 30 tablets

class:

Prescription

prescription_type:

Prescription

manufactured_by:

Cipla Ltd

therapeutic_indication:

Donepezil tablets are indicated for the treatment of mild, moderate and severe Alzheimer's disease.

leaflet_short:

Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC/AI, 10 tablets per blister strip, Sample pack - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVDC/AI, 10 tablets per blister strip - 90 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVDC/AI, 10 tablets per blister strip - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVDC/AI, 10 tablets per blister strip - 250 tablets - 36 months from date of manufacture stored at or below 25°C

authorization_date:

2006-06-30

SPC

1
NEW ZEALAND DATASHEET
1 PRODUCT NAME
Donepezil
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Donepezil hydrochloride 5mg and 10mg tablets.
3 PHARMACEUTICAL FORM
Donepezil film-coated tablets for oral administration are supplied
containing 5 mg donepezil
hydrochloride, equivalent to 4.56 mg donepezil free base, or 10 mg
donepezil hydrochloride,
equivalent to 9.12 mg donepezil free base.
Donepezil 5mg tablets are white, circular, biconvex film-coated
tablets, embossed ‘DPZ’ on
one side and ‘5’ on the other side. The tablet diameter is
approximately 7.1 mm.
Donepezil 10mg tablets are yellow, circular, biconvex film-coated
tablets, embossed ‘DPZ’
on one side and ‘10’ on the other side. The tablet diameter is
approximately 9.1 mm.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Donepezil tablets are indicated for the treatment of mild, moderate
and severe Alzheimer's
disease.
Donepezil tablets are indicated for the treatment of vascular dementia
(dementia associated
with cerebrovascular disease).
4.2 Dose and method of administration
ADULTS/ELDERLY
It is recommended that the diagnosis and treatment of Alzheimer’s
disease should be
initiated and supervised by a doctor with appropriate experience in
Alzheimer’s disease.
Individual patient response to donepezil therapy cannot be predicted.
Where a therapeutic benefit for the patient exists, then treatment
should be continued.
Where there is no longer evidence of a therapeutic effect,
discontinuation of therapy should
be considered. The physician should periodically assess the
therapeutic effect using input
from the patient and caregiver. Donepezil usage in patients with other
types of memory
impairment (e.g. age-related cognitive decline) or other types of
dementia has not been
established.
5mg and 10mg dosages of donepezil hydrochloride administered once
daily in controlled
clinical trials have been shown to be effective. With the 10mg dose
per day there is no
statistically significant evidence that a greater treatment effect is
obtained from this