ARICEPT-D donepezil Hydrochloride 10 mg Tablet Blister pack.

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

donepezil hydrochloride

Saatavilla:

Pfizer Australia Pty Ltd

INN (Kansainvälinen yleisnimi):

Donepezil hydrochloride

Valtuutuksen tilan:

Registered

Pakkausseloste

ARICEPT
®
_donepezil hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Aricept. 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 Aricept
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 ARICEPT IS USED
FOR
Aricept is used to treat mild,
moderate and severe Alzheimer's
disease, also called dementia of the
Alzheimer's type.
Aricept 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
Aricept in children has not been
established.
BEFORE YOU TAKE
ARICEPT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ARICEPT 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 is damaged, return
it to your pharmacist for disposal.
IF YOU ARE NOT SURE WHETHER YOU
S

Valmisteyhteenveto

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AUSTRALIAN
PRODUCT
INFORMATION
–
ARICEPT
®
,
ARICEPT
®
-D
(DONEPEZIL
HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Donepezil hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ARICEPT film-coated tablets for oral administration are supplied
containing 5 mg or 10 mg
donepezil hydrochloride equivalent to 4.56 mg or 9.12 mg donepezil
free base, respectively.
ARICEPT-D orally disintegrating tablets are supplied containing 5 mg
or 10 mg donepezil
hydrochloride equivalent to 4.56 mg or 9.12 mg donepezil free base,
respectively.
EXCIPIENT(S) WITH KNOWN EFFECT_ _
ARICEPT contains lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients
3.
PHARMACEUTICAL FORM
ARICEPT 5 mg film-coated tablets: white, round, film-coated, debossed
tablets, marked
‘ARICEPT’ on one side and ‘5’ on the other side.
ARICEPT 10 mg film-coated tablets: yellow, round, film-coated,
debossed tablets, marked
‘ARICEPT’ on one side and ‘10’ on the other side.
ARICEPT-D 5 mg orally disintegrating tablets: white, embossed tablets,
marked ‘ARICEPT’
on one side and ‘5’ on the other side.
ARICEPT-D
10
mg
orally
disintegrating
tablets:
yellow,
embossed
tablets,
marked
‘ARICEPT’ on one side and ‘10’ on the other side.
Not all presentations may be marketed.
_ _
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ARICEPT (donepezil hydrochloride) is indicated for the treatment of
mild, moderate and
severe Alzheimer’s disease.
_ _
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4.2 DOSE AND METHOD OF 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
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