DONEPEZIL AN donepezil hydrochloride 5mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

donepezil hydrochloride

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Donepezil hydrochloride

Authorization status:

Registered

Patient Information leaflet

_Donepezil AN tablets – Consumer Medicine Information _
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_Doc ID: 110.AN.M.1.0 _
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_ _
_Page 1 _
DONEPEZIL AN TABLETS
_Donepezil hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Donepezil
AN.
It
does
not
contain
all
the
available
information.
It
does
not
take
the
place
of
talking
to
your
doctor
or
pharmacist.
All
medicines
have
risks
and
benefits.
Your
doctor
has
weighed the risks of you taking
Donepezil
AN
against
the
benefits they expect it will have
for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT USING THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT DONEPEZIL AN IS
USED FOR
Donepezil AN is used to treat
mild,
moderate
and
severe
Alzheimer’s disease, also called
dementia
of
the
Alzheimer’s
type.
Donepezil AN will not cure this
disease,
but
should
help
your
memory
and
improve
your
thinking capacity.
This
medicine
belongs
to
a
group
of
medicines
called
acetylcholinesterase
inhibitors.
They
are
thought
to
work
by
increasing
the
level
of
a
chemical called acetylcholine in
the brain.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your
doctor
may
have
prescribed it for another reason.
This medicine is not addictive.
This medicine is only available
with a doctor's prescription.
Before you take.
BEFORE YOU TAKE
DONEPEZIL AN
_WHEN YOU MUST NOT TAKE _
_IT: _
_ _
DO NOT TAKE DONEPEZIL AN IF
YOU HAVE AN ALLERGY TO:

any
medicine
containing
donepezil hydrochloride

piperidine derivatives

any of the ingredients listed
at the end of this leaflet.
Some
of
the
symptoms
of
an
allergic
reaction
may
include
shortness of breath, wheezing or
difficulty
breathing;
swelling
of
the face, lips, tongue or other
parts of the body; rash, itching or
hives on the skin.
DO NOT GIVE DONEPEZIL AN TO
CHILDREN.
The safety and effectiveness of
Donepezil AN in children have
not been established.
DO NOT TAKE THIS MEDICINE AFTER
THE EXPIRY DATE PRINTED

Summary of Product characteristics

_Donepezil AN tablets Product Information _
_ _
_Amneal Pharma Australia Pty Ltd _
Donepezil AN PI v3.0
Page 1
DONEPEZIL AN
_ _
_(DONEPEZIL HYDROCHLORIDE TABLETS) _
_ _
PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of this medicine is Donepezil hydrochloride
CHEMICAL NAME:
(RS)-1-benzyl-4-[5,6-dimethoxy-1-indanon)-methylpiperidine
hydrochloride
MOLECULAR FORMULA:
C
24
H
29
NO
3.
HCl
MOLECULAR WEIGHT:
415.96
CAS REGISTRY NUMBER:
120011-70-3
DESCRIPTION
Donepezil hydrochloride is a specific and reversible inhibitor of the
enzyme acetylcholinesterase.
Donepezil hydrochloride is a white crystalline powder and is freely
soluble in chloroform, soluble
in water and in glacial acetic acid, slightly soluble in ethanol and
in acetonitrile and practically
insoluble in ethyl acetate and in n-hexane.
Donepezil AN 5 mg tablets are white to off-white, round, bevelled
edged, biconvex, film coated
tablet with inscription "5" on one side and plain on other side.
Donepezil AN 10 mg tablets are yellow, round, biconvex, film coated
tablet with inscription "10"
on one side and plain on other side.
Donepezil AN tablets contains the following excipients: lactose, maize
starch, microcrystalline
cellulose, hydroxypropylcellulose,
magnesium stearate, Opadry complete film coating system OY
-38951 WHITE [PI No.: 106399] (for 5 mg strength) and Opadry complete
film coating system
03B32654 YELLOW [PI No.: 106398] (for 10 mg strength).
PHARMACOLOGY
_Donepezil AN tablets Product Information _
_ _
_Amneal Pharma Australia Pty Ltd _
Donepezil AN PI v3.0
Page 2
It It has been demonstrated that Alzheimer's disease is associated
with a relative decrease in the
activity of the cholinergic system in the cerebral cortex and other
areas of the brain. Studies
suggest
that
donepezil
hydrochloride
exerts
its
therapeutic
effect
by
enhancing
cholinergic
function in the central nervous system. This is accomplished by
increasing the concentration of
acetylcholine through reversible inhibition of acetylcholinesterase.
PHARMACODYNAMICS
Donepezil
hydrochloride