APO-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)
15-03-2022
Summary of Product characteristics
(SPC)
15-03-2022
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
donepezil hydrochloride, Quantity: 10 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
Donepezil hydrochloride
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: lactose monohydrate; maize starch; hyprolose; purified talc; microcrystalline cellulose; titanium dioxide; sodium stearylfumarate; macrogol 6000; iron oxide yellow; hypromellose
Administration route:
Oral
Units in package:
28
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: Yellow, circular, biconvex, film coated tablets embossed with 'C' on one side and '6' 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:
Licence status A
Authorization date:
2013-09-23
Patient Information leaflet
APO-DONEPEZIL
1
APO-DONEPEZIL
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 APO-DONEPEZIL?
APO-DONEPEZIL contains the active ingredient donepezil hydrochloride.
APO-DONEPEZIL 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 APO-DONEPEZIL? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE APO-DONEPEZIL?
Do not use if you have ever had an allergic reaction to APO-DONEPEZIL
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
APO-DONEPEZIL?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with APO-DONEPEZIL 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 APO-DONEPEZIL?
•
The usual starting dose is one APO-DONEPEZIL 5 mg tablet each day
•
After one month, your doctor will assess your response and may
increase your dose to one APO-DONEPEZIL 10 mg tablet each day.
More instructions can be found in Section 4. How do I use
APO-DONEPEZIL? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING APO-DONEPEZIL?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using
APO-DONEPEZIL.
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
•
APO-DONEPEZIL may cause fatigue, dizziness and muscle cramps,
especially at the start of
treatment.
•
Be careful driving or operating machinery until you know how
APO-DONEPEZIL affects you.
•
Alzheimer’s disease may affect your ability to drive or operate
machi
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Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION
APO-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
APO-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-day dosing). Donepezil
tablets sho
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