DONEPEZILGENEPHARM 5 mg orodispersible tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Donepezil Hydrochloride

Boleh didapati daripada:

MEDISPEC (M) SDN.BHD

INN (Nama Antarabangsa):

Donepezil Hydrochloride

Unit dalam pakej:

2 x 14 Tablets; 2 x 14 Tablets

Dikeluarkan oleh:

GENEPHARM S.A

Risalah maklumat

DONEPEZIL/GENEPHARM ORODISPERSIBLE
TABLET
Donepezil Hydrochloride (5mg & 10mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Donepezil/Genepharm is used
for
2.
How Donepezil/Genepharm works
3.
Before you use
Donepezil/Genepharm
4.
How to use Donepezil/Genepharm
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Donepezil/Genepharm
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DONEPEZIL/GENEPHARM_ _IS USED
FOR
Donepezil/Genepharm
(donepezil
hydrochloride)
belongs
to
a
group
of
medicines
called
acetylcholinesterase
inhibitors.
It is used to treat dementia in people
diagnosed as having mild, moderate and
severe
Alzheimer’s
disease.
The
symptoms
include
increasing
memory
loss, confusion and behavioral changes.
As
a
result,
sufferers
of
Alzheimer’s
disease find it more and more difficult to
carry out their normal daily activities.
Donepezil/Genepharm is for use in adult
patients only.
HOW DONEPEZIL/GENEPHARM_ _WORKS
Donepezil increases the levels of a
substance (acetylcholine) in the brain
involved in memory function by slowing
down the breakdown of acetylcholine.
BEFORE YOU USE DONEPEZIL/GENEPHARM
Tell the doctor about all your present or
past health problems. Including:
•
Any
heart
problems
including
problems with irregular, slow or fast
heartbeats.
•
A heart condition called ‘prolonged
QT interval’ or a history of certain
abnormal
heart
rhythms
called
Torsade de Pointes or if anyone in
your
family
have
‘prolonged
QT
interval’.
•
Low
levels
of
magnesium
or
potassium in your blood.
-
_When you must not use it _
• if you are allergic (hypersensitive)
to
donepezil
hydrochloride,
or
to
piperidine derivatives, or any of the
other
ingredients
of
Donepezil/Genepharm.
_-Before you start to use it _
Tell your doctor or pharmacist before
starting to take Donepezil/Genepharm if
you have or have had:
• stomach or duodenal ulcers
• seizures (fits) or convulsions
• a heart condition (irregular or ve

Ciri produk

DONEPEZIL/GENEPHARM ORODISPERSIBLE TABLETS
(5MG & 10MG)
DONEPEZIL/GENEPHARM 5 MG ORODISPERSIBLE TABLET
Each orodispersible tablet contains Donepezil HCl 5mg equivalent to
Donepezil 4.56mg
DONEPEZIL/GENEPHARM 10 MG ORODISPERSIBLE TABLET
Each orodispersible tablet contains Donepezil HCl 10mg equivalent to
Donepezil 9.12mg
PRODUCT DESCRIPTION
DONEPEZIL/GENEPHARM 5 MG ORODISPERSIBLE TABLET
White to off-white round, flat tablets, with bevelled edges, embossed
with ‘5’ on one side and
plain on the other
DONEPEZIL/GENEPHARM 10 MG ORODISPERSIBLE TABLET
White to off-white round, flat tablets, with bevelled edges, embossed
with ‘10’ on one side and
plain on the other
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: anti-dementia drugs, anticholinesterases
ATC code: N06DA02.
Donepezil hydrochloride is a specific and reversible inhibitor of
acetylcholinesterase, the
predominant cholinesterase in the brain. Donepezil hydrochloride is
_in vitro _
over 1000 times
more potent an inhibitor of this enzyme than of butyrylcholinesterase,
an enzyme that is present
mainly outside the central nervous system.
In patients with Alzheimer's dementia, administration of single daily
doses of 5 mg or 10 mg of
donepezil hydrochloride produced steady-state inhibition of
acetylcholinesterase activity
(measured in erythrocyte membranes) of 63.6% and 77.3%, respectively
when measured post
dose. The inhibition of acetylcholinesterase (AChE) in red blood cells
by donepezil hydrochloride
has been shown to correlate to changes in ADAS-cog, a sensitive scale
that examines selected
aspects of cognition. The potential for donepezil hydrochloride to
alter the course of the
underlying neuropathology has not been studied. Thus, donepezil cannot
be considered to have
any effect on the progress of the disease.
PHARMACOKINETIC PROPERTIES
_ _
_Absorption: _
_ _
Maximum plasma levels are reached approximately 3 to 4 hours after
oral administration. Plasma
concentrations and area under the curve rise in proportion to the
dose. The terminal dispositio