ARICEPT Donepezil hydrochloride 10mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

donepezil hydrochloride, Quantity: 10 mg (Equivalent: donepezil, Qty 9.12 mg)

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; maize starch; lactose monohydrate; hyprolose; titanium dioxide; macrogol 8000; hypromellose; purified talc; iron oxide yellow

Administration route:

Oral

Units in package:

28 tablets, 14 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ARICEPT (donepezil hydrochloride) is indicated for the treatment of mild, moderate and severe Alzheimer's disease.

Product summary:

Visual Identification: yellow, film coated, round tablet, engraved with "Aricept" on one side and "10" on the other.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1998-03-30

Patient Information leaflet

ARICEPT®
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®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ARICEPT?
Aricept contains the active ingredient donepezil hydrochloride.
Aricept is used to treat mild, moderate and severe Alzheimer’s
disease, also called dementia of the Alzheimer’s type.
For more information, see Section 1. Why am I using [medicine name]?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ARICEPT?
Do not use if you have ever had an allergic reaction to Aricept or any
of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become pregnant
or are breastfeeding.
For more information, see Section 2. What should I know before I use
Aricept? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Aricept and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ARICEPT?
•
The usual starting dose is one Aricept 5 mg tablet each day
•
After one month, your doctor will assess your response and may
increase your dose to one Aricept 10 mg tablet each day.
More instructions can be found in Section 4. How do I use Aricept? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ARICEPT?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using Aricept.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking your medicine or change the dosage without checking
with your doctor first.
DRIVING
OR USING
MACHINES
•
Aricept may cause fatigue, dizziness and muscle cramps, especially at
the start of treatment.
•
Be careful driving or operating machinery until you know how Aricept
affects you.
•
Alzheimer’s disease may affect your ability to drive or operate
machinery.
•
Ask your doctor whether it is safe for you to continue to drive or
operate machin

Summary of Product characteristics

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Page 1 of 28
AUSTRALIAN
PRODUCT
INFORMATION
–
ARICEPT
® (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.
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.
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.
_ _
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 be assessed by periodic evaluations
by the physician using
input from the patient and caregiver.
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Supersedes: pfparict11019
Page 2 of 28
The dosages of ARICEPT 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 patien