Donepezil IPCA

Země: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktivní složka:

Donepezil hydrochloride 10mg

Dostupné s:

Ipca Pharma (NZ) Pty Limited

INN (Mezinárodní Name):

Donepezil hydrochloride 10 mg

Dávkování:

10 mg

Léková forma:

Film coated tablet

Složení:

Active: Donepezil hydrochloride 10mg Excipient: Hyprolose Hypromellose Iron oxide yellow Lactose Macrogol 6000 Maize starch Microcrystalline cellulose Purified talc Purified water Sodium stearyl fumarate Titanium dioxide

Druh předpisu:

Prescription

Výrobce:

Hetero Drugs Limited

Terapeutické indikace:

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

Přehled produktů:

Package - Contents - Shelf Life: Blister pack, PVDC/PVC/Al - 84 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVDC/PVC/Al - 90 tablets - 36 months from date of manufacture stored at or below 30°C

Datum autorizace:

2013-08-21

Charakteristika produktu

NEW ZEALAND DATA SHEET – DONEPEZIL IPCA
1
PRODUCT NAME
Donepezil IPCA 5mg, 10 mg, film coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablets contains 5mg donepezil hydrochloride
Each tablet contains 10 mg donepezil hydrochloride
Excipient(s) with known effect
Contains Lactose
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Donepezil 10 mg Tablets are yellow colored, circular, biconvex, film
coated tablets
embossed with ‘C’ on
one side and ‘6’ on the other side.
Donepezil 5 mg Tablets are white to off-white, circular, biconvex,
film coated tablets
embossed with ‘C’ on
one side and ‘7’ on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Donepezil is indicated for the treatment of mild, moderate and severe
Alzheimer’s disease.
Donepezil is indicated for the treatment of vascular dementia
(dementia associated
with cerebrovascular
disease.
4.2 DOSE AND METHOD OF ADMINISTRATION
_ADULTS/ELDERLY _
Treatment should be initiated and supervised by a doctor experienced
in the diagnosis and treatment of
Alzheimer’s
Dementia.
Individual
response
to
donepezil
cannot
be
predicted.
Treatment
should
be
continued for as long as a therapeutic benefit for the patient exists.
Discontinuation of therapy should
be considered where there is no longer evidence of a therapeutic
effect, which should be assessed by
periodic evaluations by the physician using input from the patient and
caregiver. The use of donepezil in
patients with other types of
dementia or other types of memory impairment (e.g., age-related
cognitive
decline), has not
been established.
The dosages of donepezil shown to be effective in controlled clinical
trials are 5 mg and 10 mg
administered once daily. Although there is no statistically
significant evidence that a greater treatment
effect is obtained from the use of the 10 mg dose, there is a
suggestion,
based on analysis of group data
that some additional benefits may accrue to some patients
from the use of the higher dose.
Treatment is ini