Reductil

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Sibutramine hydrochloride

Patient Information leaflet

Reductil Capsules 
Version 11  
24 March 2010 
1 of 6

CONSUMER MEDICINE 
INFORMATION 
REDUCTIL® 
SIBUTRAMINE HYDROCHLORIDE 

10MG AND 15MG CAPSULES 

WHAT IS IN THIS LEAFLET 

Please read this leaflet 
carefully before starting 
Reductil. 

This leaflet answers some 
common questions about 
Reductil.  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 
considered the risks and 
benefits of you taking 
Reductil. 

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 REDUCTIL IS USED FOR  

Reductil contains the active 
ingredient sibutramine 
hydrochloride. 

Reductil belongs to a group 
of medicines called serotonin 
and noradrenaline reuptake 
inhibitors. 

Reductil is used to treat very 
overweight (obese) patients, 
who have not been able to 
lose weight using a low 
calorie diet and exercise. 

Your ideal weight may not be 
achieved even with Reductil. 

Reductil is a medicine used 
to help you lose and maintain 
weight loss.  It works by 
making you feel satisfied with 
less food.  It helps control 
how much you eat.  You 
should still get hungry but 
feel full with less food than 
before.  By eating less, it 
should be easier for you to 
lose weight – even if you 
haven’t been able to before. 

Reductil does not work in the 
same way as traditional 
appetite suppressants. It 
works by altering the level of 
two chemicals in the brain, 
serotonin and noradrenaline, 
which help regulate energy 
intake and output.  

The result is: 
(1) you will not need to eat as 
much during your meals 
before you feel full, and 
(2) Reducti

Summary of Product characteristics

 
Reductil Capsules 
Version 15  
6 September 2010 
1 of 18 
PRODUCT INFORMATION 

REDUCTIL
®

NAME OF THE MEDICINE 
Sibutramine hydrochloride 

The structural formula is shown below:

Cl
C
CH
2
CH
2
CH
2
CH
N
CH
3
CH
3
CH
2
CH
CH
3
CH
3
•

HCl

•

H
2
O   

CAS Number: 125494-59-9 
DESCRIPTION 
Reductil (sibutramine hydrochloride) is the first
orally administered serotonin (5-
hydroxytryptamine, 5HT) and noradrenaline reuptake inhibitor
(SNRI) to be used for 
the management of obesity. 

Chemically, sibutramine hydrochloride monohydrate is
a racemic mixture of the (+) 
and (-) enantiomers of N-{1-[1-(4-chlorophenyl)
cyclobutyl]-3-methylbutyl}-N, N-
dimethylamine hydrochloride, monohydrate, and has an empirical
formula of 
C
17
H
29
Cl
2
NO.  Its molecular weight is 334.33.  The INN
for the free base is 
‘sibutramine’. The CAS Number for sibutramine free base is CAS
106650-56-0. 

Sibutramine hydrochloride is a white to cream crystalline powder
with a solubility of 
2.9 mg/mL in pH 5.2 water. Its octanol:water partition coefficient is
30.9 at pH 5.0. 

Each Reductil capsule contains 10mg, or 15mg of sibutramine
hydrochloride. It also 
contains as inactive ingredients: lactose, cellulose
- microcrystalline, silica-colloidal 
anhydrous and magnesium stearate in a hard-gelatin
capsule [which contains gelatin, 
sodium lauryl sulfate, titanium dioxide, shellac, lecithin,
dimethicone, propylene 
glycol, indigo carmine CI73015, iron oxide black CI77499 and
quinoline yellow CI 
47005 (10mg capsules only.)]

PHARMACOLOGY 
MODE OF ACTION 
Sibutramine produces its therapeutic effects predominantly via its
active secondary 
and primary amine metabolites (metabolites 1 and 2
respectively), which are 
inhibitors of noradrenaline, serotonin (5-hydroxytryptamine;
5-HT) and dopamine 
Reductil Capsules 
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6 September 2010 
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reuptake.  In hum