ARIDON APN 10 donepezil hydrochloride 10mg tablet blister pack

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

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

Disponibil de la:

Arrotex Pharmaceuticals Pty Ltd

INN (nume internaţional):

Donepezil hydrochloride

Forma farmaceutică:

Tablet, film coated

Compoziție:

Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; magnesium stearate; maize starch; hyprolose; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 400

Calea de administrare:

Oral

Unități în pachet:

28 tablets

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

Donepezil hydrochloride is indicated for the treatment of mild, moderate and severe Alzheimer?s disease.

Rezumat produs:

Visual Identification: Yellow, round, biconvex, film coated tablets with inscription "10" on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statutul autorizaţiei:

Licence status A

Data de autorizare:

2011-03-02

Prospect

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

Caracteristicilor produsului

1
AUSTRALIAN PRODUCT INFORMATION – ARIDON APN 5, ARIDON APN
10 (DONEPEZIL HYDROCHLORIDE) FILM COATED TABLETS
1
NAME OF THE MEDICINE
Donepezil hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Donepezil hydrochloride is a specific and reversible inhibitor of the
enzyme acetylcholinesterase.
ARIDON APN tablets come in two strengths and contain either 5 mg or 10
mg of donepezil
hydrochloride.
Excipients with known effect: contains sugars as (lactose).
For the full list of excipients, SEE SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ARIDON APN 5 are white to off-white, round, bevelled edge, biconvex,
film coated tablets with
inscription "5" on one side and plain on other side.
ARIDON APN 10 are yellow, round, biconvex, film coated tablets with
inscription "10" on one side and
plain on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Donepezil hydrochloride is indicated for the treatment of mild,
moderate and severe
†
Alzheimer’s
disease.
4.2
D
OSE AND METHOD OF ADMINISTRATION
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 can not be
predicted. Treatment should be
2
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.
Treatment is initiated at 5 mg/day (once-a-day dosing). Donepezil
hydrochloride should be taken
orally,