DONEPEZIL GH donepezil hydrochloride (as monohydrate) 5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

donepezil hydrochloride, Quantity: 5 mg

Available from:

Generic Health Pty Ltd

INN (International Name):

Donepezil hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: macrogol 6000; maize starch; lactose monohydrate; titanium dioxide; purified talc; microcrystalline cellulose; sodium stearylfumarate; hypromellose; hyprolose

Administration route:

Oral

Units in package:

28, 84, 60, 112, 50, 56, 14, 120, 30, 98

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Donepezil is indicated for the treatment of mild, moderate and severe Alzheimer's disease.

Product summary:

Visual Identification: White to off white, circular biconvex, film-coated tablets, embossed with 'C' on one side and '7' on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2012-10-22

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
DONEPEZIL GH
(DONEPEZIL HYDROCHLORIDE (AS MONOHYDRATE)) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Donepezil GH. 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 GH 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 GH IS
USED FOR
Donepezil GH is used to treat
mild, moderate and severe
Alzheimer's disease, also called
dementia of the Alzheimer's
type.
Donepezil GH 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 GH in children has
not been established.
BEFORE YOU TAKE
DONEPEZIL GH
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE DONEPEZIL GH 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 PACK OR IF THE
PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – DONEPEZIL GH
(DONEPEZIL HYDROCHLORIDE (AS MONOHYDRATE)) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Donepezil hydrochloride (as monohydrate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DONEPEZIL GH 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.
List of excipients with known effects: lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
DONEPEZIL GH 5 mg film-coated tablets: white to off white, circular,
biconvex, film-coated tablets,
embossed with ‘C’ on one side and ‘7’ on the other side.
DONEPEZIL GH 10 mg film-coated 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 GH is indicated for the treatment of mild, moderate and
severe Alzheimer’s disease.
4.2 DOSE AND METHOD OF ADMINISTRATION
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 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 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.
Donepezil GH v3.0
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(donepezil hydrochloride(as monohyd