ALZER 5 (Donepezil Hydrochloride Tablets 5mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DONEPEZIL HCL

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

DONEPEZIL HCL

Unit dalam pakej:

10x10tablet Tablets

Dikeluarkan oleh:

Hetero Labs Limited

Risalah maklumat

ALZER 5 (DONEPEZIL HYDROCHLORIDE TABLETS 5MG)
ALZER 10 (DONEPEZIL HYDROCHLORIDE TABLETS 10MG)
(Donepezil Hydrochloride tablets 5mg/ Donepezil Hydrochloride tablets
10mg )
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What ALZER 5 / ALZER 10 is
used for
2.
How ALZER 5 / ALZER 10 works
3.
Before you use ALZER 5 / ALZER
10
4.
How to use ALZER 5 / ALZER 10
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of ALZER 5 /
ALZER 10
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT ALZER 5 / ALZER 10
IS USED
FOR
Donepezil Tablets contains a medicine
called
Donepezil
Hydrochloride.
This
belongs to a group of medicines called
acetylcholinesterase inhibitors.
It
is
used
to
treat
the
symptoms
of
dementia in people diagnosed as having
mild, moderate and severe 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 ALZER 5 / ALZER 10
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 ALZER 5 / ALZER 10
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 _
_ _
DO NOT TAKE DONEPEZIL_ TABLETS_
If
you
are
allergic
(hypersensitive)
to
donepezil hydrochloride or any of the
other ingredients of Donepezil Tablets.
_Take _
_special _
_care _
_with _
_Donepezil _
_Tablets _
Tell your doctor or pharmacist before
starting to take Donepezil Tablets if you
have or have had:
•
stomach

Ciri produk

_Excretion_
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.
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
PHARMACOKINETICS
_Distribution_
_Absorption_
It is about 95% bound to human plasma proteins, mainly albumin.
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.
_Metabolism_
Donepezil tablets are indicated for the treatment of mild, moderate,
and severe dementia in
Alzheimer's disease.
Following a 4 to 6 weeks of clinical assessment in patients who
tolerated treatment at 5mg/day,
the dose of Donepezil can be increased to 10mg/day (once-a-day
dosing). The maximum
recommended daily dose is 10mg.
_Severe Alzheimer's disease_
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 clinical