Valdoxan

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Agomelatine

Available from:

Servier Laboratories (Australia) Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

VALDOXAN
®
 25MG

_Agomelatine (pronounced a-go-mel-a-tin)_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VALDOXAN. It
does not contain all the available
information. You can obtain more
information about VALDOXAN by
talking to your doctor or pharmacist.
All medications have risks and
benefits. Your doctor has weighed
the risks of you taking VALDOXAN
against the benefits this medicine 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 VALDOXAN IS
USED FOR
VALDOXAN is used in the
treatment of depression or to help
prevent depression returning, and is
only available with a doctor's
prescription. The symptoms of
depression vary from one person to
another, but commonly include
persistent sadness, loss of interest in
favourite activities, feelings of
worthlessness, sleep problems,
feeling of being slowed down,
feelings of anxiety or changes in
appetite and weight. Changes in your
daily sleep and appetite patterns are
examples of disturbances of your
'body clock' that occur commonly in
depression.
VALDOXAN can help regulate your
'body clock' (circadian rhythm) with
positive benefits on mood and sleep
in depression.
VALDOXAN is not addictive.
VALDOXAN is not recommended
for children or adolescents (under 18
years old).
Your doctor may prescribe
VALDOXAN for another purpose.
Ask your doctor if you have any
questions about why VALDOXAN
has been prescribed for you.
BEFORE YOU TAKE
VALDOXAN
There are some people who shouldn't
take VALDOXAN. Please read the
list below. If you think any of these
situations apply to you or you have
any questions, please see your
doctor.
_WHEN YOU MUST NOT TAKE_
_VALDOXAN_
DO NOT TAKE VALDOXAN IF:
•
YOU SUFFER FROM LIVER DISEASE OR
YOU KNOW YOUR LIVER DOES NOT
WORK PROPERLY (HEPATIC
IMPAIRMENT).
•
YOU ARE CURRENTLY TAKING
FLUVOXAMINE (A DRUG USED IN THE
TREATMENT OF DEPRESSION) OR
CIPR

Summary of Product characteristics

VALDOXAN
_®_

– PRODUCT INFORMATION   

   1 (16) 

Version 13a 
_VALDOXAN_
_®_
_ _
PRODUCT INFORMATION 

NAME OF THE MEDICINE 

_VALDOXAN _
Agomelatine 25mg 

DESCRIPTION 

The  active  component  of  VALDOXAN  is  agomelatine  which  has  the  chemical  name:  N-[2-(7-
methoxy-1-naphthyl)ethyl]  acetamide.    Agomelatine  is  practically  insoluble  in  purified  water  (<0.1 
mg/mL)  but  freely  soluble  (>100  mg/mL)  in  various  organic  solvents  (96%  ethanol,  methanol, 
methylene chloride).  Agomelatine
has no asymmetric carbon atom. 

CAS Registry Number_: _
_138112-76-2_
_ _
_ _
_Molecular formula_: C
15
H
17
NO
2
  (MW = 243.3). 

_Chemical structure_: 

_Excipients:_  Lactose,  starch  -  maize,  povidone,  sodium  starch glycollate,  stearic  acid,  magnesium 
stearate,  silica  -  colloidal  anhydrous,  hypromellose,  iron  oxide  yellow  (CI77492), 
glycerol,  macrogol  6000,  and  titanium  dioxide  (CI77891),  shellac,  indigo  carmine 
(CI73015), propylene glycol. 

PHARMACOLOGY 

PHARMACODYNAMICS 

Pharmacotherapeutic group: Other antidepressants (ATC-code: NO6AX22) 

VALDOXAN  (agomelatine)  is  a  melatonin  receptor  (MT
1
  and  MT
2
)  agonist  and  5-HT
2C
  receptor 
antagonist.  VALDOXAN (agomelatine) has shown an antidepressant-like effect in animal models 
of  depression  (learned  helplessness  test,  despair  test,  chronic  mild  stress),  in  models  with 
circadian rhythm desynchronisation and in
models related to stress and anxiety. 

In vitro studies
indicate that VALDOXAN (agomelatine) has no effect on monoamine uptake
and no 
affinity  for 

  or 

  adrenergic,  histaminergic,  cholinergic,  dopaminergic,  or  benzodiazepine 
recept