Alzhicept Tablets 10mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DONEPEZIL HCL

Boleh didapati daripada:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (Nama Antarabangsa):

DONEPEZIL HCL

Unit dalam pakej:

500tablet Tablets

Dikeluarkan oleh:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
ALZHICEPT TABLETS 10MG
Donepezil hydrochloride 10mg
WHAT IS IN THIS LEAFLET

What Alzhicept Tablets is used
for

How Alzhicept Tablets works

Before
you
use
Alzhicept
Tablets

How to use Alzhicept Tablets

While you are using Alzhicept
Tablets

Side Effects

Storage
and
Disposal
of
Alzhicept Tablets

Product description

Manufacturer
and
Product
Registration Holder

Date of Revision
WHAT ALZHICEPT TABLETS IS USED
FOR
Donepezil
Hydrochloride
Tablets
are used to treat the symptoms of
mild,
moderate
and
severe
dementia
in
people
diagnosed
as
having
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.
This
medicine
is
only
available
with a doctor’s prescription
HOW ALZHICEPT TABLETS WORKS
Donepezil belongs to a group of
medicines
called
acetylcholinesterase
inhibitors.
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 ALZHICEPT TABLETS
- _When you must not use it _
Do not take Alzhicept Tablets if
your have an allergy to:

Any
medicine
containing
donepezil hydrochloride.

Piperidine derivatives

Any of the ingredients listed at
the end of this leaflet.
Do not give Alzhicept Tablets to
children.
The
safety
and
effectiveness
of
Alzhicept in children have not been
establised.
If
you are not sure
whether you
should be taking Alzhicept Tablets,
talk to your doctor.
- _Before you start to use it _
Tell
your
doctor
if
you
have
allergies
to
any
other
medicines,
foods, preservatives or dyes.
Tell your doctor if you plan to go to
hospital for surgery that requires a
general anaesthetic.
Tell your doctor if your have or
have
had
any
of
the
following
medical conditions:

stomach or duodenal ulcers

seizures (fits) or convulsions

a
heart
condit

Ciri produk

7196-00
ALZHICEPT TABLETS 10MG
Alzhicept Tablets 10mg : A bluish green, scored, convex of diameter
8.5mm round tablet with “MPI” marking.
PHARMACOLOGY:
Donepezil is a piperidine derivative, chemically distinct from other
agents in this class. Donepezil demonstrates
relatively high selectivity for central nervous system
acetylcholinesterase, with minimal peripheral activity. It
reversibly
and
noncompetitively
inhibits
centrally-active
acetylcholinesterase,
the
enzyme
responsible
for
hydrolysis of acetylcholine. This is expected to result in increased
concentrations of acetylcholine that are available
for synaptic transmission. Alzheimer's’disease is characterized by
cholinergic deficiency in the cortex and basal
forebrain, which contributes to cognitive deficits. Donepezil does not
alter the course of the underlying dementing
process.
PHARMACOKINETICS:
_ABSORPTION _
Donepezil hydrochloride is well absorbed from the gastrointestinal
tract, maximum plasma concentrations being
achieved within 3 to 4 hours after ingestion. Food did not affect the
absorption of donepezil hydrochloride.
_ _
_DISTRIBUTION _
It is about 95% bound to human plasma proteins, mainly albumin.
_ _
_METABOLISM _
Donepezil is metabolized in the liver. Donepezil undergoes partial
metabolism via the cytochrome P450 isoenzyme
CYP3A4, and to a lesser extent by CYP2D6, to 4 major metabolites.
About 11% of a dose is present in plasma as
6-O-desmethyldonepezil, which has similar activity to the parent
compound.
_EXCRETION _
Over 10 days, about 57% of a dose is recovered from the urine as
unchanged drug and metabolites, and about 15%
from the faeces; 28% remains unrecovered suggesting accumulation. The
elimination half-life is about 70 hours.
Steady-state concentrations are achieved within 3 weeks of the start
of therapy.
_ _
* Sex, race and smoking history have no clinically significant
influence on plasma concentrations of donepezil
hydrochloride.
COMPOSITION:
Alzhicept Tablets 10mg
:
Each tablet contains 10mg of donepezil hydrochloride
INDICATIO