Chemmart Baclofen

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Baclofen

Available from:

Apotex Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

CHEMMART BACLOFEN
TABLETS

_contains the active ingredient, baclofen_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE ASK YOUR
DOCTOR OR PHARMACIST IF YOU DO NOT
UNDERSTAND ANYTHING OR ARE
WORRIED ABOUT TAKING YOUR
MEDICINE.
This leaflet answers some common
questions about baclofen.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. Some more recent
information on the medicine may be
available. Speak to your pharmacist
or doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may want to read it again.
WHAT CHEMMART
BACLOFEN IS USED FOR
The name of your medicine is
Chemmart Baclofen. It contains the
active ingredient, baclofen.
It is used to control muscle spasms in
conditions such as:
•
multiple sclerosis
•
spinal cord damage resulting
from disease or physical injury
_HOW IT WORKS_
Baclofen belongs to a group of
medicines called muscle relaxants.
It is used to reduce excess tension in
your muscles which causes spasms.
Because this medicine reduces
spasms and the pain that goes with
them, it helps to make you more
mobile. This helps you to manage
your daily activities more easily.
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 available only with
a doctor's prescription.
There is no known evidence to show
that this medicine is addictive.
_USE IN CHILDREN_
These tablets should not be given to
children under 33 kg in weight.
Information about baclofen use in
children under 16 years is very
limited.
BEFORE YOU TAKE
CHEMMART BACLOFEN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE HAD AN ALLERGIC REACTIO

Summary of Product characteristics

Product Information – Australia 

Chemmart Baclofen Tablets 
Page 1 
CHEMMART BACLOFEN TABLETS 

NAME OF THE MEDICINE 
Baclofen 

Chemical Name: 
(RS)-4 amino-3 (4-chlorophenyl)butyric acid.  

Structural Formula: 

Molecular Formula:  

C
10
H
12
ClNO
2

Molecular Weight:  

213.7 

CAS Registry Number:  1134-47-0 

DESCRIPTION  

Baclofen is a white or almost white powder, which is slightly soluble in water, very slightly soluble in 
ethanol (96%), and practically insoluble in acetone and in
ether. It dissolves in dilute mineral acids 
and in dilute alkali hydroxides.  

PHARMACOLOGY 
PHARMACOKINETICS 
Absorption 
Absorption from the gastrointestinal tract is rapid and
complete. After an oral dose, peak plasma 
levels of unchanged drug are achieved in 1 to 2
hours.  The bioavailability of oral baclofen is 70 to 
80%. 

Following oral administration of a single dose of 40mg
baclofen, peak serum concentrations of 500 to 
600 nanogram/mL are reached.  The serum concentration remains above
200 nanogram/mL for 8 
hours.  The onset of action is highly variable and
may range from hours to weeks.  

Distribution 
The distribution volume of baclofen
is about 0.7 L/kg. In cerebrospinal fluid, the active
substance 
attains concentrations approximately 8.5 times lower than in
the plasma.  

Baclofen is about 30% bound to plasma proteins.  

Metabolism 
About 15% of a dose of baclofen is metabolised in the liver.  The main metabolite is 
b-chlorophenyl 
gamma
hydroxybutyric acid, which is pharmacologically inactive.  

Product Information – Australia 

Chemmart Baclofen Tablets 
Page 2 
Excretion  
Baclofen is eliminated largely in unchanged form. The plasma
elimination half-life of baclofen has 
been reported at between 2 and 6.8 hours.
 Approxim