Aricept Evess Orodispersible Tablet 5mg

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

DONEPEZIL HCL

Available from:

EISAI (MALAYSIA) SDN BHD (18039-D)

INN (International Name):

DONEPEZIL HCL

Units in package:

28Tablet Tablets

Manufactured by:

Bushu Pharmaceuticals Ltd. Misato factory

Patient Information leaflet

_ _
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ARICEPT EVESS ORODISPERSIBLE TABLET
®
Donepezil Hydrochloride (5mg,10mg)
1
WHAT IS IN THIS LEAFLET
1.
What
_ARICEPT ® EVESS _
is used
for
2.
How
_ARICEPT ® EVESS _
works
3.
Before you use
_ARICEPT ® _
_EVESS_
4.
How to use
_ARICEPT ® EVESS_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_ARICEPT® EVESS _
8.
Product
Description
9.
Manufacturer and Product
Registration
Holder
10. Date of revision
WHAT _ARICEPT ® EVESS _IS USED FOR
_ _
_ARICEPT ® EVESS _
is a prescription
medicine to treat dementia in
Alzheimer’s disease. The symptoms
include increasing memory loss,
confusion and behavioural changes. As
a result, sufferers of Alzheimer’s
disease find it more and more difficult
to carry out their normal daily
activities.
HOW _ARICEPT ® EVESS _WORKS
_ _
_ARICEPT® EVESS_
will not cure this
disease, but should help your memory
and improve your ability to think more
clearly.
This medicine belongs to a group of
medicines called acetylcholinesterase
inhibitors. They are thought to work
by increasing the levels of a substance
(acetylcholine) in the brain involved in
memory function by slowing down the
breakdown of acetylcholine.
_ARICEPT® _
_EVESS _
has
not
been
approved
as
a
treatment
for
any
medical condition in children.
BEFORE YOU USE _ARICEPT® EVESS_
-
_ _
_When you must not use it _
You should not take
_ARICEPT ® _
_EVESS_
-
if you are allergic to Donepezil
Hydrochloride or any of the
ingredients in
_ARICEPT ® _
_EVESS _
or to medicines that
contain piperidines.
-
if you are not sure. See the end of
this leaflet for a list of ingredients
in
_ARICEPT ® EVESS_
.
_ _
_ _
_Pregnancy and lactation _
Do not take
_ARICEPT® EVESS _
if you
are pregnant, trying to get pregnant or
think you may be pregnant.
Do not take
_ARICEPT ® EVESS _
if you
are breast- feeding. Ask your doctor or
pharmacist for advice before taking
any medicine.
-
_ Before you start to use it _
_ _
Tell the doctor about all your present
or past health
problems.

Summary of Product characteristics

MS
416
ARICEPT
®
EVESS
5MG, 10MG
_Donepezil Hydrochloride _
_Orodispersible Tablet_
_ _
_ _
_ _
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Aricept Evess 5 mg orodispersible tablet
Aricept Evess 10 mg orodispersible tablet
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
For excipients, see 6.1
3.
PHARMACEUTICAL FORM
Orodispersible Tablet
White tablet debossed with "5" on one side and "Aricept" on the other
side.
Yellow tablet debossed with "10" on one side and "Aricept" on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
Aricept Evess tablets are indicated for the treatment of mild,
moderate, and
severe dementia in Alzheimer's Disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS/ELDERLY:
MILD TO MODERATE ALZHEIMER'S DISEASE
Treatment is initiated at 5mg/day (once-a-day dosing). Aricept Evess
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. The 5mg/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
5mg/day,
the dose of Aricept Evess can be increased to 10mg/day (once-a-day
dosing).
The maximum recommended daily dose is 10mg. Doses greater than
10mg/day
have not been studied in clinical trials.
Upon discontinuation of treatment, a gradual abatement of the
beneficial effects
of Aricept is seen.
SEVERE ALZHEIMER'S DISEASE
Aricept has been shown to be effective in controlled clinical trials
at a dose of
10mg administered once daily.
Evidence from the controlled trials in mild to moderate Alzheimer's
Disease
indicates that the 10mg dose, with one week titration, is likel