Arimac 5 (Donepezil hydrochloride Tablets 5 mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DONEPEZIL HCL

Boleh didapati daripada:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

DONEPEZIL HCL

Unit dalam pakej:

30tablet Tablets

Dikeluarkan oleh:

Macleods Pharmaceuticals Limited

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
ARIMAC 5 (DONEPEZIL HCL TABLETS 5MG)
ARIMAC 10 (DONEPEZIL HCL TABLETS 10MG)
Donepezil Hydrochloride (5mg & 10mg)
1
WHAT IS IN THIS LEAFLET
1.
What Arimac is used for
2.
How Arimac works
3.
Before you use Arimac
4.
How to use Arimac
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Arimac
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS ARIMAC USED FOR
Arimac is used for the symptomatic
treatment of mild, moderate & severe
dementia in Alzheimer’s disease.
HOW ARIMAC WORKS
Arimac
is
one
of
a
group
of
medicines called acetylcholinesterase
inhibitor. It increases the levels of a
substance (acetylcholine) in the brain
involved
in
memory
function
by
slowing
down
the
breakdown
of
acetylcholine.
BEFORE YOU USE ARIMAC
-When you must not use it
If
you
are
allergic
to
donepezil
hydrochloride
or
to
piperidine
derivatives,
or
any
of
the
other
ingredients of Arimac. If you are in
any doubt at all, consult your doctor
before taking donepezil.
-Before you start to use it
Talk to your doctor before taking
Arimac if you:
•
Develop
stomach
or
duodenal ulcers.
•
Seizures
(fits)
or
convulsions.
•
A heart condition (irregular or
very slow heart beat)
•
Asthma or other long term lung
disease.
•
Liver problems or hepatitis.
•
Difficulty
passing
urine
or
mild kidney disease.
•
If you are pregnant, think you
may be pregnant or are planning
to have a baby, ask your doctor
or pharmacist for advice before
taking any medicine.
•
If you are taking Arimac, you
should not breast-feed
Children and Adolescents: Arimac is
not recommended for use in children.
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
inter

Ciri produk

ATC Code for Donepezil : N06DA02
Pharmacotherapeutic group : Acetylcholinesterase inhibitor
MODE OF ACTION
Donepezil hydrochloride is a specific and reversible inhibitor of
acetylcholinesterase, the
redominant 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.
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.
Food does not influence
the rate or extent of absorption of donepezil tablets.
DISTRIBUTION: Donepezil hydrochloride is approximately 95% bound to
human plasma
proteins. The plasma protein binding of the active metabolite
6-O-desmethyldonepezil is
not known. The distribution of donepezil hydrochloride in various body
tissues has not been
definitively studied.
METABOLISM & EXCRETION:
Donepezil hydrochloride is both excreted in the urine intact and
metabolised by the
cytochrome P450 system to multiple metabolites, not all of which have
been identified.
Following administration of a single 5 mg dose of 14C-labeled
donepezil hydrochloride,
plasma radioactivity, expressed as a percent of the administered dose,
was present
primarily as intact donepezil hydrochloride (30%), 6-O-desmethyl
donepezil (11% - only
metabolite that exhibits activity similar to donepezil hydrochloride),
donepezil-cis-N-oxide
(9%), 5-O-desmethyl donepezil (7%) and the glucuronide conjugate of
5-O-desmethyl
donepezil (3%). Approximately 57% of the total administered
radioactivity was recovered
from the urine (17% as unchanged donepezil), and 14.5% was recovered
from the faeces,
suggesting biotra