DONEPEZIL SYNTHON

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

Donepezil hydrochloride monohydrate

Доступна з:

Synthon Au Pty Ltd

Клас:

Medicine Registered

інформаційний буклет

 
Common Technical Document
Donepezil hydrochloride (as monohydrate) 
film-coated tablets 

Module 1 - Section 3.2
page 1/9

1.3.2 
Consumer Medicine Information (CMI) 
DONEPEZIL-SYNTHON  

NAME OF THE ACTIVE INGREDIENT:  
DONEPEZIL HYDROCHLORIDE AS MONOHYDRATE 

WHAT IS IN THIS LEAFLET 

This leaflet answers some common questions about Donepezil-Synthon.
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-Synthon against the benefits they expect it will
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-SYNTHON IS USED FOR 

Donepezil-Synthon film-coated tablets are 
indicated for the symptomatic 
treatment of
 mild to moderately severe 
Alzheimer’s dementia.

Donepezil-Synthon will not cure this disease, but should help your
memory 
and improve your thinking capacity. 

Donepezil-Synthon 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.  

This medicine is only available with a doctor's prescription. 

issue date: 20-02-08 

version: 
M1.03.2_02.DEI.hcl.mhy.tab.003.04.WD

Common Technical Document
Donepezil hydrochloride (as monohydrate) 
film-coated tablets 

Module 1 - Section 3.2
page 2/9

BEFORE YOU TAKE DONEPEZIL-SYNTHON 

WHEN YOU MUST NOT TAKE IT 

DO NOT TAKE DONEPEZIL-SYNTHON IF YOU HAVE AN ALLERGY TO: 
•  DONEPEZIL-SYNTHON OR RELATED MEDICINES 
•  ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET.  

Symptoms of an allergic reaction to these medicines may include: 
•  asthma, wheezing or shortness of breath 
• �

Характеристики продукта

 
Common Technical Document
Donepezil hydrochloride (as monohydrate) 
film-coated tablets 

Module 1 - Section 3.1
page 1/25

1.3.1 
Product Information (PI) 
PRODUCT INFORMATION 

NAME OF THE MEDICINE:  
DONEPEZIL-SYNTHON  

NAME OF THE ACTIVE INGREDIENT:  
DONEPEZIL HYDROCHLORIDE AS MONOHYDRATE 

DESCRIPTION 

Donepezil hydrochloride is a specific and reversible inhibitor of the
enzyme 
acetylcholinesterase, known chemically as
(RS)-1-benzyl-4-[(5,6-dimethoxy-
1-indanon)-2-yl]methylpiperidine  hydrochloride monohydrate. The
CAS 
reference number for donepezil hydrochloride is 120011-70-3.
Donepezil 
hydrochloride monohydrate has an empirical formula of C
24
H
29
NO
3
·HCl·H
2
O 
and a molecular weight of 433.98 and is represented by the following 
structural formula:

H
3
CO
H
3
CO
O
N
HCl
.
H
2
O
.
*

Donepezil hydrochloride monohydrate is a white to slightly yellow
powder 
and is soluble in dimethylsulfoxide, water and methanol. It is
insoluble in 
ethyl acetate, toluene and in n-heptane. 

DonpeSyn for oral administration are supplied containing 5 mg or 10 mg
of 
donepezil hydrochloride (as the monohydrate) equivalent to 4.56 mg or
9.12 
mg of donepezil, respectively. The inactive ingredients are
lactose, 
microcrystalline cellulose, sodium starch glycolate, hydroxypropyl
cellulose, 
and magnesium stearate. The film coating contains hypromellose,
lactose, 
macrogol 4000, and titanium dioxide. Additionally, the 10 mg tablet
contains 
yellow iron oxide as a colouring agent. 

issue date: 02.06.08 

version:M1.03.1_02.DEI.hcl.mhy.tab.003.06approved: 

Common Technical Document
Donepezil hydrochloride (as monohydrate) 
film-coated tablets 

Module 1 - Section 3.1
page 2/25

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 sugges