SETRONA

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

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29-05-2024

Thành phần hoạt chất:

Sertraline hydrochloride

Sẵn có từ:

Ranbaxy Australia Pty Ltd

Lớp học:

Medicine Registered

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SETRONA CMI V5 May 2011 
 
   Page 1 of 11 
SETRONA  
_SERTRALINE HYDROCHLORIDE TABLETS_ 
CONSUMER MEDICINE INFORMATION 
 
WHAT IS IN THIS LEAFLET  
This leaflet answers some common questions about SETRONA 
(sertraline).  
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 SETRONA against the benefits it is 
expected to have for you. 
IF YOU HAVE ANY CONCERNS ABOUT USING/TAKING THIS MEDICINE, ASK 
YOUR DOCTOR OR PHARMACIST. 
Keep this leaflet with this medicine. You may need to read it 
again. 
 
WHAT SETRONA TABLET IS USED FOR 
SETRONA  tablets contain the active ingredient sertraline.
Sertraline 
belongs to a group of medicines known
as selective serotonin reuptake 
inhibitors (SSRIs). These medicines are thought to work by
increasing 
the activity of the chemical serotonin in the brain.  
SETRONA tablets are used to treat the following conditions: 
SETRONA is used to treat depression and conditions called obsessive 
compulsive disorder (OCD), panic disorder, social phobia (social 
anxiety disorder) and premenstrual dysphoric disorder (PMDD).  
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. This imbalance affects your whole body and can
cause emotional 
and physical symptoms such as feeling low in spirit, loss
of interest 
in activities, being unable to enjoy life, poor appetite or 
overeating, disturbed sleep, often waking up early, loss of sex 
drive, lack of energy and feeling guilty over nothing. SETRONA 
corrects this
                                
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SETRONA PI V10 Apr 11 
 
 
 
 
Page 1 of 25 
SETRONA 
(
SERTRALINE HYDROCHLORIDE TABLETS
) 
 
NAME OF THE MEDICINE 
 
Sertraline Hydrochloride 
 
_CAS Number:_ 79559-97-0  
 
DESCRIPTION 
 
SETRONA tablets contain (1S, 4S)-4-(3, 4-dichlorophenyl)-1, 2, 3,
4-tetrahydro-N-
methyl-1-naphthalenamine hydrochloride. The empirical formula of
sertraline 
hydrochloride is C
17
H
17
NCl
2
•HCl and its molecular weight is 342.7. Its structure is: 
 
 
 
 
Sertraline hydrochloride is a white crystalline powder that is
slightly soluble in water 
and isopropyl alcohol and sparingly soluble in ethanol. 
 
SETRONA tablets contain the following inactive
ingredients: microcrystalline 
cellulose, calcium hydrogen phosphate, sodium starch glycollate
(Type A), hydroxy 
propyl cellulose, magnesium stearate.  
 
FILM COATING MATERIAL: OPADRY OY-S-58910 WHITE  
-Hypromellose, titanium dioxide (E171), macrogol 400, purified
talc. 
 
PHARMACOLOGY 
 
  MECHANISM OF ACTION 
The mechanism of action of sertraline is presumed to be linked to
its inhibition of 
CNS neuronal uptake of serotonin (5HT). Studies at
clinically relevant doses in man 
have demonstrated that sertraline blocks the uptake of serotonin into
human platelets. 
_In vitro_ studies in animals also suggest that sertraline is a
potent and selective 
inhibitor of neuronal serotonin reuptake and has only very weak
effects on 
noradrenaline and dopamine neuronal reuptake. _In vitro_ studies
have shown that 
                                         
                                       
              
             
SETRONA PI V10 Apr 11 
 
 
 
 
Page 2 of 25 
sertraline has no significant affinity to adrenergic (

1
, 

2
, 
) choli
                                
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