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

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

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

Pieejams no:

Dr Reddys Laboratories Australia Pty Ltd

SNN (starptautisko nepatentēto nosaukumu):

donepezil hydrochloride monohydrate

Zāļu forma:

Tablet, film coated

Kompozīcija:

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

Ievadīšanas:

Oral

Vienības iepakojumā:

14, 28

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

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

Produktu pārskats:

Visual Identification: Yellow round, biconvex, bevel edged, film coated tablets debossed 'DNP' on one side and '10' on opposite side; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Autorizācija statuss:

Registered

Lietošanas instrukcija

Consumer Medicine Information for Donepezil-DRLA V3
Page 1 of 11
DONEPEZIL-DRLA TABLETS
_Donepezil hydrochloride monohydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Donepezil-DRLA. It
does not
contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicine have risks and benefits. Your doctor has weighed the
risks of you taking
Donepezil-DRLA against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERN ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT DONEPEZIL-DRLA IS USED FOR
Donepezil-DRLA Tablets are used to treat mild, moderate and severe
Alzheimer’s
disease, also called dementia of the Alzheimer’s type.
Donepezil-DRLA will not cure this disease, but should help your memory
and
improve your ability to think more clearly.
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.
Consumer Medicine Information for Donepezil-DRLA V3
Page 2 of 11
This medicine is not addictive.
This medicine is only available with a doctor’s prescription.
BEFORE YOU TAKE DONEPEZIL-DRLA
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE DONEPEZIL-DRLA IF YOU HAVE AN ALLERGY TO:

Any medicine containing donepezil hydrochloride monohydrate

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 breathing; swelling of the face, lips, tongue
or other parts of the
body; rash, itching or hives on the skin.
DO NOT GIVE DONEPEZIL-DRLA TO CHILDREN.
The
safety
and
effectiveness
of
Donepezil-DRLA
in
children
have
not
been
e

Produkta apraksts

DONEPEZIL-DRLA TABLETS
PRODUCT INFORMATION
NAME OF THE MEDICINE
Active:
Donepezil hydrochloride monohydrate
CAS Number: 120011-70-3
.
HCl.
.
H
2
O
DESCRIPTION
Donepezil hydrochloride monohydrate 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.
Chemical Name:
(_RS_)-1-benzyl-4-[5,6-dimethoxy-1-indanon)-2-yl]-
methylpiperidine
hydrochloride monohydrate.
Molecular formula:
C
24
H
29
NO
3
HCl.H
2
O
Molecular Weight:
433.97
Excipient:
Lactose monohydrate, pregelatinised maize starch, microcrystalline
cellulose,
hyprolose, magnesium stearate. The film coating
contains
macrogol 400, hypromellose, titanium
dioxide.
Additionally, the 10 mg
tablet contains yellow iron oxide as a
colouring agent.
ACTIONS
Specific and reversible acetylcholinesterase inhibitor.
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
Product Information for Donepezil-DRLA V3
Product Information for Donepezil-DRLA –V3
2 of 34
accomplished by increasing the concentration of acetylcholine through
reversible
inhibition of acetylcholinesterase.
PHARMACODYNAMICS
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 1,000 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 donepezil hydrochloride 5 or 10 mg produced
steady-state
inhibition of acetyl