DONEPEZIL-TEVA donepezil hydrochloride (as monohydrate) 10 mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

donepezil hydrochloride

Available from:

Teva Pharma Australia Pty Ltd

INN (International Name):

Donepezil hydrochloride

Authorization status:

Registered

Patient Information leaflet

Donepezil-Teva Version 1.0
1
DONEPEZIL-TEVA
_donepezil hydrochloride (as monohydrate)_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about donepezil
hydrochloride. 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
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT DONEPEZIL
HYDROCHLORIDE IS USED
FOR
Donepezil hydrochloride is used to
treat mild, moderate and severe
Alzheimer's disease, also called
dementia of the Alzheimer's type.
Donepezil hydrochloride will not
cure this disease, but should help
your memory and improve your
ability to think more clearly.
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.
_USE IN CHILDREN_
The safety and effectiveness of
donepezil hydrochloride in children
has not been established.
BEFORE YOU TAKE
DONEPEZIL
HYDROCHLORIDE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE DONEPEZIL
HYDROCHLORIDE 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 TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PAC

Summary of Product characteristics

Product Information
Donepezil-Teva 5 mg & 10 mg Film-coated Tablets
Page 1
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Teva Pharma Australia Pty Ltd
Version 1.0
PRODUCT INFORMATION
DONEPEZIL-TEVA [DONEPEZIL HYDROCHLORIDE (AS MONOHYDRATE)]
NAME OF THE MEDICINE
Donepezil-Teva 5 mg film-coated tablet
Donepezil-Teva 10 mg film-coated tablet
The structural formula of donepezil hydrochloride (as monohydrate) is
shown below:
Active ingredient:
donepezil hydrochloride (as monohydrate)
Chemical name:
(±)-2-[(1-Benzyl-4-piperidyl)methyl]-5,6-dimethoxy-1-
indanone hydrochloride monohydrate
Molecular formula:
C
24
H
29
NO
3
·HCl·H
2
O
Molecular weight:
433.97
CAS Registry Number:
884740-09-4
DESCRIPTION
Donepezil hydrochloride (as monohydrate) 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-Teva
film-coated
tablets
for
oral
administration
are
supplied
containing
5
mg or
10 mg donepezil hydrochloride (as monohydrate) equivalent to 4.56 mg
or 9.12 mg
donepezil free base,
respectively. The inactive ingredients are lactose, pregelatinised
maize
starch, microcrystalline cellulose, sodium starch glycollate (type A),
colloidal anhydrous silica
and magnesium stearate.
The film coating for both 5 mg and 10 mg strengths contains
macrogol 4000, hypromellose, titanium dioxide and lactose.
Additionally, the 10 mg tablet
contains iron oxide yellow.
PHARMACOLOGY
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 acetylch