Donecept-10 (Donepezil Hydrochloride Tablets 10mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DONEPEZIL HCL

Boleh didapati daripada:

CIPLA MALAYSIA SDN BHD

INN (Nama Antarabangsa):

DONEPEZIL HCL

Unit dalam pakej:

30tablet Tablets

Dikeluarkan oleh:

Cipla Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DONECEPT-5 & DONECEPT-10 TABLETS
Donepezil Hydrochloride (5mg,10mg)
1
WHAT IS IN THIS LEAFLET
1.
What DONECEPT is used for
2.
How DONECEPT works
3.
Before you use
DONECEPT
4.
How to use DONECEPT
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
DONECEPT
8.
Product Description
9.
Manufacturer and Product
Registration
Holder
10.
Date of revision
WHAT DONECEPT_ _IS USED FOR
DONECEPT
_ _
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 DONECEPT WORKS
DONECEPT 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.
DONECEPT
_ _
has not been approved
as
a
treatment
for
any
medical
condition in children.
BEFORE YOU USE DONECEPT_ _
-
_When you must not use it _
You should not take DONECEPT
_ _
-
if you are allergic to Donepezil
Hydrochloride or any of the
ingredients in DONECEPT or
to medicines that contain
piperidines.
-
if you are pregnant, trying to get
pregnant or
think
you
may
be
pregnant.
-
if you are breast- feeding.
-
_Before you start to use it _
Tell the doctor about all your present
or past health problems. Include:
•
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 has ‘prolonged QT
interval’
•
Low levels of magnesium or
potassium in your blood
•
Asthma or lung problems
•
Other types of memory impairment
•
Any movement

Ciri produk

DONECEPT-5 (DONEPEZIL HYDROCHLORIDE TABLETS 5MG)
DONECEPT-10 (DONEPEZIL HYDROCHLORIDE TABLETS 10MG)
Donepezil Hydrochloride
COMPOSITION
DONECEPT-5
Each tablet contains Donepezil Hydrochloride 5mg.
DONECEPT-10
Each tablet contains Donepezil Hydrochloride 10mg.
DOSAGE FORM
Film coated tablet
DONECEPT-5
White, circular, biconvex film coated tablet with ‘5’ debossed on
one side and ‘DPZ’
debossed on the other side.
DONECEPT-10
Yellow, circular, biconvex film coated tablet with ‘10’ debossed
on one side and ‘DPZ’
debossed on the other side.
PHARMACOLOGY
PHARMACODYNAMICS
Pharmacotherapeutic group: anti-dementia drugs; anticholinesterase.
ATC code: N06DA02
Donepezil hydrochloride is a specific and reversible inhibitor of
acetyl cholinesterase, 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.
Alzheimer's Dementia
The inhibition of acetyl cholinesterase (AChE) in red blood cells by
donepezil hydrochloride
has been shown to correlate to changes in ADAS-cog, a sensitive scale
which 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.
PHARMACOKINETICS
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
disposition half-life is approximately 70 hours, thus, administration
of multiple single daily
doses results in gradual approach to steady-state. Approximate
steady-state is achieved within
3 weeks after initiation of therapy.
Once
at
steady-state,
plasma
donepezil
hydrochloride
concentrations
and
the
related
pharmacodynamic activity show little variability over the course of
the day. Food did not
affec