JUBDOZIL (Donepezil hydrochloride Tablets 5 mg)

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
30-11-2020
Ciri produk Ciri produk (SPC)
12-09-2020

Bahan aktif:

DONEPEZIL HCL

Boleh didapati daripada:

SYNERRV SDN BHD

INN (Nama Antarabangsa):

DONEPEZIL HCL

Unit dalam pakej:

30tablet Tablets

Dikeluarkan oleh:

Jubilant Generics Limited

Risalah maklumat

                                _Consumer Medication Information Leaflet (RiMUP) _
JUBDOZIL TABLET
Donepezil hydrochloride 5mg
Donepezil hydrochloride 10mg
1
WHAT IS IN THIS LEAFLET
1.
What is JUBDOZIL
Tablet used for
2.
How JUBDOZIL
Tablet works
3.
Before you use
JUBDOZIL Tablet
4.
How to use
JUBDOZIL Tablet
5.
While you are using
JUBDOZIL Tablet
6.
Side Effects
7.
Storage and Disposal of
JUBDOZIL Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
1.
WHAT JUBDOZIL
TABLET IS USED FOR
JUBDOZIL Tablet is used for
the symptomatic treatment of
mild to moderately severe
Alzheimer’s dementia.
2.
HOW JUBDOZIL TABLET
WORKS
Donepezil hydrochloride
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.
3.
BEFORE YOU USE
JUBDOZIL TABLETS
_WHEN YOU MUST NOT USE IT _

If you are allergic
(hypersensitive) to donepezil
hydrochloride, to related
substances (piperidine
derivates) or to any of the
other ingredients of
donepezil hydrochloride.

During pregnancy and breast
feeding.

In children under 18 years of
age.
_BEFORE YOU START TO USE IT _
Follow all instructions given to
you by your doctor carefully,
even if they differ from the
information contained in this
leaflet.
_TAKING OTHER MEDICINES _
Please tell your doctor or
pharmacist if you are taking, or
have recently taken, any other
medicine. This includes
medicines that your doctor has
not prescribed for you but which
you have bought yourself from a
chemist/pharmacist. It also
applies to medicines you may
take sometime in the future if
you continue to take donepezil
hydrochloride. This is because
these medicines may weaken or
strengthen the effects of
donepezil hydrochloride.
Especially tell your doctor if you
are taking any of the following
types of medicines:

Other Alzheimer’s disease
medicines, e.g. galantamine

Pain killers or treatment for
arthritis e.g. aspirin, non-
s
                                
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Ciri produk

                                Black
Last modified: 9. September 2020, 4:49 PM
REASON FOR ARTWORK: NEW
ITEM CODE: XXXXXXXXXX
SUBSTRATE: 40 GSM BIBLE PAPER WITH FOLDING SIZE 62 X 31 MM
SITE PACKAGING DEVELOPMENT
SIGN AND DATE
PRODUCTION
SIGN AND DATE
QA
SIGN AND DATE
DIMENSION: 310 X 240 MM
SUPERSEDED ITEM CODE: NA
For the use of a registered medical practitioner or a hospital or a
laboratory only JUBDOZIL
(Donepezil Hydrochloride Tablets 5 mg) JUBDOZIL
(Donepezil Hydrochloride Tablets 10 mg)
PRODUCT NAME:
JUBDOZIL (Donepezil Hydrochloride Tablets 5 mg)
JUBDOZIL (Donepezil Hydrochloride Tablets 10 mg)
NAME AND STRENGTH OF ACTIVE INGREDIENT:
Each film-coated tablet of:
Jubdozil
(Donepezil
Hydrochloride
Tablets
5
mg)
contains
Donepezil
hydrochloride
5
mg
Jubdozil (Donepezil Hydrochloride Tablets 10 mg) contains Donepezil
hydrochloride 10 mg
PRODUCT DESCRIPTION:
DONEPEZIL HYDROCHLORIDE TABLETS 5MG
White to off-white, round, film-coated tablets, debossed with ‘J’
on one side and ‘5’ on the other.
DONEPEZIL HYDROCHLORIDE TABLETS 10MG
White to off-white, round, film-coated tablets, debossed with ‘J’
on one side and ‘10’ on the other.
PHARMACODYNAMICS / PHARMACOKINETICS:
Pharmacodynamic properties:
Pharmacotherapeutic groups: Anti-dementia drugs; Anticholinesterase;
ATC Code: N06DA02.
Donepezil
hydrochloride
is
a
reversible
inhibitor
of
acetylcholinesterase,
the
predominant
cholinesterase in the brain. Donepezil hydrochloride is over 1000
times more potent an inhibitor of
this enzyme than of butyrylcholinesterase, an enzyme which is present
mainly outside the central
nervous system.
MECHANISM OF ACTION
Current theories on the pathogenesis of the cognitive signs and
symptoms of Alzheimer’s disease
attribute some of them to a deficiency of cholinergic
neurotransmission. Donepezil hydrochloride
is postulated to exert its therapeutic effect by enhancing cholinergic
function. This is accomplished
by increasing the concentration of acetylcholine through reversible
inhibition of its hydrolysis
by acetylcholinesterase. There is no evidence t
                                
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