TERRY WHITE CHEMISTS DONEPEZIL donepezil hydrochloride (as monohydrate) 10 mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
donepezil hydrochloride
Available from:
Apotex Pty Ltd
INN (International Name):
Donepezil hydrochloride
Authorization status:
Registered
Patient Information leaflet
TERRY WHITE CHEMISTS DONEPEZIL TABLETS
1
TERRY WHITE CHEMISTS
DONEPEZIL TABLETS
_Contains the active ingredient donepezil hydrochloride (as
monohydrate) _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about donepezil. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is Terry
White Chemists Donepezil. It
contains the active ingredient
donepezil hydrochloride (as
monohydrate).
It is used to treat mild, moderate and
severe Alzheimer's disease, also
called dementia of the Alzheimer's
type.
This medicine will not cure this
disease, but it should help your
memory and improve your ability to
think more clearly.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
_HOW IT WORKS _
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.
_USE IN CHILDREN
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Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION
TERRY WHITE CHEMISTS DONEPEZIL (DONEPEZIL HYDROCHLORIDE
MONOHYDRATE) TABLETS
1
NAME OF THE MEDICINE
Donepezil hydrochloride monohydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg or 10 mg donepezil hydrochloride (as
monohydrate) as the active ingredient,
equivalent to 4.56 mg or 9.12 mg donepezil free base, respectively.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
5 MG TABLETS: White to off-white, circular, biconvex, film coated
tablets embossed with “C” on one side
and “7” on the other side.
10 MG TABLETS: Yellow, circular, biconvex, film coated tablets
embossed with “C” on one side and “6”
on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Donepezil hydrochloride is indicated for the treatment of mild,
moderate and severe Alzheimer’s
disease.
4.2
DOSE AND METHOD OF ADMINISTRATION
Terry White Chemists Donepezil tablets are intended for oral
administration.
DOSAGE
ADULTS / ELDERLY
Treatment should be initiated and supervised by a doctor experienced
in the diagnosis and treatment
of
Alzheimer’s
Dementia.
Individual
response
to
donepezil
hydrochloride cannot
be
predicted.
Treatment
should
be
continued
for
as
long
as
a
therapeutic
benefit
for
the
patient
exists.
Discontinuation of therapy should be considered where there is no
longer evidence of a therapeutic
effect, which should be assessed by periodic evaluations by the
physician using input from the patient
and caregiver.
The dosages of donepezil hydrochloride shown to be effective in
controlled clinical trials are 5 mg and
10 mg administered once daily. Although there is no statistically
significant evidence that a greater
treatment effect is obtained from the use of the 10 mg dose, there is
a suggestion, based on analysis
of group data, that some additional benefits may accrue to some
patients from the use of the higher
dose.
2
Treatment is initiated at 5 mg/day (once-a-
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