DONEPEZIL GENERICHEALTH

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

donepezil hydrochloride monohydrate

Disponibbli minn:

Sun Pharma ANZ Pty Ltd

INN (Isem Internazzjonali):

donepezil hydrochloride monohydrate

Fuljett ta 'informazzjoni

Page 1 of 9
DONEPEZIL GENERICHEALTH
_DONEPEZIL HYDROCHLORIDE_ _5/10 MG TABLETS _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
DONEPEZIL
GENERICHEALTH (donepezil hydrochloride). It does not contain all the
available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking DONEPEZIL GENERICHEALTH against the benefits it is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT DONEPEZIL GENERICHEALTH IS USED FOR
DONEPEZIL GENERICHEALTH tablets are used to treat mild, moderate and
severe Alzheimer's disease, or dementia of the Alzheimer's type.
DONEPEZIL GENERICHEALTH will not cure this disease, but should help
improve your memory and thinking capacity.
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.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
This medicine is only available with a doctor's prescription.
BEFORE YOU TAKE DONEPEZIL GENERICHEALTH
_WHEN YOU MUST NOT TAKE IT _
Page 2 of 9
Do not take
DONEPEZIL GENERICHEALTH
if you have an allergy to:
•
any medicine containing donepezil hydrochloride
•
piperidine derivatives
•
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include shortness of
breath, wheezing or difficulty in breathing; swelling of the face,
lips, tongue or other parts of the body; rash, itching or hives on the
skin.
LACTOSE:
DONEPEZIL GENERICHEALTH contains lactose. If you have been
told by your doctor that you have intolerance to some sugars, contact
your doctor before taking D

Karatteristiċi tal-prodott

DONEPEZIL GENERICHEALTH PI V8 August 2012
Page 1 of 27
DONEPEZIL GENERICHEALTH
Donepezil Hydrochloride 5 & 10 mg Tablets
NAME OF THE MEDICINE
Donepezil hydrochloride (as monohydrate)
Structural formula (of the anhydrous form):
Molecular Formula: C
24
H
29
NO
3
HCl
Chemical
Name:
(
_RS_
)-1-benzyl-4-[5,6-dimethoxy-1-indanon)-2-yl]-methylpiperidine
hydrochloride
Molecular Weight: 415.96
CAS Number: 120011-70-3
DESCRIPTION
Donepezil hydrochloride (as monohydrate) is a white to off-white
crystalline powder and is
freely soluble in chloroform, sparingly soluble in water, methanol and
acetic acid. It has a
pKa of 8.9 and a logP of 4.27. A 1% concentration of donepezil
hydrochloride in water has a
pH of 5.4.
DONEPEZIL GENERICHEALTH film-coated tablets for oral administration
each contain 5
mg or 10 mg of donepezil hydrochloride equivalent to 4.56 or 9.12 mg
donepezil free base,
respectively. The inactive ingredients are lactose, maize starch,
hydroxypropylcellulose,
microcrystalline cellulose, sodium starch glycollate type A and
magnesium stearate. The film
coating contains hypromellose, titanium dioxide, macrogol 400,
purified talc and iron oxide
yellow.
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 hydrochloride 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 GENERICHEALTH PI V8 August 2012
Page 2 of 27
Donepezil hydrochloride is a specific and reversible inhibitor of
acetylcholinesterase, the
predominant cholinesterase in the brain. Donepezil hydrochloride 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 pa