CHEMMART DONEPEZIL donepezil hydrochloride (as monohydrate) 10 mg tablet blister pack

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

donepezil hydrochloride

Dostupné s:

Apotex Pty Ltd

INN (Mezinárodní Name):

Donepezil hydrochloride

Stav Autorizace:

Registered

Informace pro uživatele

CHEMMART DONEPEZIL
TABLETS
_Contains the active ingredient donepezil hydrochloride (as
monohydrate)_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about donepezil. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Chemmart Donepezil. It contains the
active ingredient donepezil
hydrochloride (as monohydrate).
It is used to treat mild, moderate and
severe Alzheimer's disease, also
called dementia of the Alzheimer's
type.
This medicine will not cure this
disease, but it should help your
memory and improve your ability to
think more clearly.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
_HOW IT WORKS_
This medicine belongs to a group of
medicines called acetylcholinesterase
inhibitors. They are thought to work
by increasing the level of a chemical
called acetylcholine in the brain.
_USE IN CHILDREN_
Do not give this medicine to
children.
There is not enough informat

Charakteristika produktu

Product Information – Australia
Chemmart Donepezil Tablets
Page 1
CHEMMART DONEPEZIL TABLETS
NAME OF THE MEDICINE
Donepezil hydrochloride monohydrate.
Chemical Name:
(_RS_)-2-[(1-Benzyl-4-piperidyl)methyl]-5,6-dimethoxyindan-1-one
hydrochloride
monohydrate.
Structural Formula:
Molecular Formula:
C
24
H
29
NO
3.
HCl.H
2
O
Molecular Weight:
433.97
CAS Registry Number:
884740-09-4
DESCRIPTION
Donepezil hydrochloride is a white crystalline powder and is freely
soluble in chloroform, soluble in water
and in glacial acetic acid, slightly soluble in ethanol and in
acetonitrile and practically insoluble in ethyl
acetate and in n-hexane.
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. In
addition, each tablet contains the
following inactive ingredients: lactose, microcrystalline cellulose,
maize starch, hydroxypropyl cellulose,
sodium stearylfumarate, purified talc, macrogol 6000, hypromellose,
iron oxide yellow (10 mg tablet only)
and titanium dioxide.
PHARMACOLOGY
It has been demonstrated that Alzheimer's disease is associated with a
relative decrease in the activity of
the cholinergic system in the cerebral cortex and other areas of the
brain.
Studies suggest that donepezil exerts its therapeutic effect by
enhancing cholinergic function in the central
nervous system. This is accomplished by increasing the concentration
of acetylcholine through reversible
inhibition of acetylcholinesterase.
PHARMACODYNAMICS
Donepezil is a specific and reversible inhibitor of
acetylcholinesterase, the predominant cholinesterase in
the brain. Donepezil was found _in vitro_ to be over 1000 times more
potent an inhibitor of this enzyme than
of butyrylcholinesterase, an enzyme which is present mainly outside
the central nervous system.
In patients with Alzheimer’s Dementia participating in clinical
trials, administration of single daily doses of
5 mg or 10 mg donepezil produced steady-state inhibition of
acetylcholine