NOUMED DONEPEZIL donepezil hydrochloride (as monohydrate) 10 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

donepezil hydrochloride monohydrate, Quantity: 10.43 mg (Equivalent: donepezil hydrochloride, Qty 10 )

Available from:

AVALLON PHARMACEUTICALS PTY LTD

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; magnesium stearate; maize starch; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; 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: Yellow, round film-coated tablet with score line on one side, marking N on one side; 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:

2018-11-14

Patient Information leaflet

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

Summary of Product characteristics

Noumed
Donepezil-pi
Page 1 of 24
AUSTRALIAN PRODUCT INFORMATION
NOUMED DONEPEZIL (DONEPEZIL HYDROCHLORIDE
MONOHYDRATE)
1
NAME OF THE MEDICINE
Donepezil hydrochloride monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Noumed Donepezil 5 mg film-coated tablet contains 5 mg donepezil
hydrochloride (as
monohydrate).
Each Noumed Donepezil 10 mg film-coated tablet contains 10 mg
donepezil hydrochloride (as
monohydrate).
Excipient with known effect: Lactose
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Noumed Donepezil 5 mg – white, round film-coated tablet without
score line, marking ‘N’ on
one side
Noumed Donepezil 10 mg – yellow, round film-coated tablet with score
line, marking ‘N’ 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
Noumed
Donepezil-