DONEPEZIL SANDOZ donepezil hydrochloride (as monohydrate) 5mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

donepezil hydrochloride monohydrate, Quantity: 5.22 mg (Equivalent: donepezil hydrochloride, Qty 5 mg)

Available from:

Sandoz Pty Ltd

INN (International Name):

donepezil hydrochloride monohydrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; maize starch; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; lecithin

Administration route:

Oral

Units in package:

28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of mild, moderate and severe Alzheimer's disease.

Product summary:

Visual Identification: White, round film-coated tablet without score line; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2010-06-03

Patient Information leaflet

Donepezil Sandoz™
1
DONEPEZIL SANDOZ™
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 DONEPEZIL SANDOZ?
Donepezil Sandoz contains the active ingredient donepezil
hydrochloride. Donepezil Sandoz 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 Donepezil Sandoz?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DONEPEZIL SANDOZ?
Do not use if you have ever had an allergic reaction to Donepezil
Sandoz 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
Donepezil Sandoz?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Donepezil Sandoz 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 DONEPEZIL SANDOZ?
•
The usual starting dose is one Donepezil Sandoz 5 mg tablet each day.
•
After one month, your doctor will assess your response and may
increase your dose to one Donepezil Sandoz 10 mg tablet
each day.
More instructions can be found in Section 4. How do I use Donepezil
Sandoz?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DONEPEZIL SANDOZ?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Donepezil Sandoz.
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
•
Donepezil Sandoz may cause fatigue, dizziness and muscle cramps,
especially at the start of treatment.
•
Be careful driving or operating machinery until you know how Donepezil
Sandoz affects you.
�

Summary of Product characteristics

220316-Donepezil Sandoz-pi
Page 1 of 25
AUSTRALIAN PRODUCT INFORMATION
DONEPEZIL SANDOZ
TM (DONEPEZIL HYDROCHLORIDE
MONOHYDRATE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Donepezil hydrochloride monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Donepezil Sandoz 5 mg film-coated tablet contains 5 mg donepezil
hydrochloride (as
monohydrate).
Each Donepezil Sandoz 10 mg film-coated tablet contains 10 mg
donepezil hydrochloride (as
monohydrate).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Donepezil Sandoz 5 mg – round, white, unscored film-coated tablets.
Donepezil Sandoz 10 mg – round, yellow film-coated tablets with
score line on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of mild, moderate and severe Alzheimer's disease.
4.2
D
OSE 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 doctor using input
from the patient and caregiver.
The dosages of donepezil hydrochloride shown to be effective in
controlled clinical trials are
5 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.
Treatment is initiated at 5 mg/day (once/day dosing). The 5 mg/day
dose should be maintained
for at least one month in order to allow the earliest clinical
responses to treatment to be assessed
and to allow steady state concentrations of donepezil hydrochloride to
be ac