Edronax

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Reboxetine mesilate

Available from:

Pfizer Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

EDRONAX
®

_(ED-ROW-NACKS)_
_Reboxetine mesilate_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Edronax.
It does not contain all of 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 Edronax
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 EDRONAX IS
USED FOR
_WHAT IT DOES_
Edronax is used to treat depression.
_HOW IT WORKS_
Depression is longer lasting and/or
more severe than the 'low moods'
everyone has from time to time due
to the stress of everyday life. It is
thought to be caused by a chemical
imbalance in parts of the brain.
Edronax may correct this chemical
imbalance and help to relieve the
symptoms of depression.
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.
There is no evidence that Edronax is
addictive.
This medicine is available only with
a doctor's prescription.
_USE IN CHILDREN_
There is not enough information to
recommend the use of this medicine
in children or adolescents younger
than 18 years.
BEFORE YOU TAKE
EDRONAX
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE EDRONAX IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
reboxetine
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction to Edronax 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 TAKE EDRONAX IF YOU ARE
TAKING OTHER MEDICINES USED TO
TREAT DEPRESSION SUCH AS
MONOAMINE OXIDASE INHIBITORS
(MAOIS).
DO NOT TAKE EDRONAX IF YOU HAVE
GLAUCOMA (HIGH PRESSURE IN THE
EYE).
DO NOT GIVE THIS MEDICINE

Summary of Product characteristics

Version: pfpedrot11012 
Supersedes: pfpedrot10811 

Page 1 of 18 
PRODUCT INFORMATION 
EDRONAX


REBOXETINE MESILATE  
NAME OF THE MEDICINE 
Edronax tablets contain 5.2 mg reboxetine mesilate corresponding to 4 mg reboxetine free base. 
Structural Formula:_ _

CAS Number: 141425-90-3 
DESCRIPTION 
Chemical name: (2RS, 

RS)-2-[

-(2-ethoxyphenoxy)benzyl] morpholine methanesulfonate.  
Reboxetine mesilate has the empirical formula C
19
H
23
NO
3
-CH
4
O
3
S, and a molecular weight of 
409.50. 
Reboxetine mesilate is freely soluble in water (>20% w/v). 
Inactive ingredients: magnesium stearate, cellulose microcrystalline, silicon dioxide, crospovidone 
and calcium hydrogen phosphate. 
PHARMACOLOGY 
PHARMACODYNAMICS   
Reboxetine is a highly selective and potent inhibitor of noradrenaline reuptake.  It has only a weak 
effect on the 5-HT reuptake and does not affect the uptake of
dopamine.   
Noradrenaline reuptake inhibition, and the consequent increase of noradrenaline availability in the 
synaptic  cleft  and  modification  of  noradrenergic  transmission,  is  among  the  most  relevant 
mechanisms of action of known antidepressant drugs. 
_In vitro_ studies have shown that reboxetine has no significant affinity for adrenergic (

1
, 

2
, 

) or 
muscarinic  receptors.    Binding  to  such  receptors  has  been  described  as  being  associated  with 
Version: pfpedrot11012 
Supersedes: pfpedrot10811 

Page 2 of 18 
cardiovascular, anticholinergic and sedative side effects of other antidepressant drugs.  Reboxetine 
is devoid of _in vitro_ binding to either 

1 
or


2
 adrenoreceptors; however a functional interference 
with 

-adrenoreceptors at high doses _in vivo_ cannot be excluded. 
In healthy volunteers the administration of reboxetine single dose