AURO-SERTRALINE

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

Sertraline; Sertraline hydrochloride; sertraline (as hydrochloride)

Dostępny od:

Aurobindo Pharma Australia Pty Ltd

Klasa:

Medicine Registered

Ulotka dla pacjenta

AURO-SERTRALINE 
CONSUMER MEDICINE INFORMATION 
Version 1.2  

                          Page 1 of 5 

AURO-SERTRALINE 50 & 100 
Sertraline (as hydrochloride) 
CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS 
LEAFLET 

THIS LEAFLET ANSWERS SOME COMMON 
QUESTIONS ABOUT AURO-
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 AURO-SERTRALINE 
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  
AURO-SERTRALINE IS 
USED FOR 

AURO-SERTRALINE is used to 
treat depression and conditions 
called obsessive compulsive 
disorder (OCD), panic disorder, 
social phobia (social anxiety 
disorder) and premenstrual 
dysphoric disorder (PMDD). 

PMDD affects some women in the 
days before their period. PMDD is 
different from premenstrual 
syndrome (PMS). The mood 
symptoms (anger, sadness, tension, 
etc) in PMDD are more severe than 
in PMS and affect the woman's daily 
activities and relationships with 
others. 

AURO-SERTRALINE belongs to a 
group of medicines called selective 
serotonin reuptake inhibitors 
(SSRIs). They are thought to work 
by blocking the uptake of a chemical 
called serotonin into nerve cells in 
the brain. Serotonin and other 
chemicals called amines are 
involved in controlling mood. 

Your doctor, however, may 
prescribe AURO-SERTRALINE for 
another purpose. 

ASK YOUR DOCTOR IF YOU HA

Charakterystyka produktu

Product Information:   
AURO-SERTRALINE 50 & 100 (Sertraline Tablets 50 mg & 100 mg)

                           Ver 2.1 

Page 1 of 24 

PRODUCT INFORMATION 

AURO-SERTRALINE 50 (50 MG SERTRALINE TABLETS) 
AURO-SERTRALINE 100 (100 MG SERTRALINE TABLETS)

NAME OF MEDICINE 

Sertraline as Sertraline hydrochloride.   

HNCH
3
.HCL
CL
CL
.

CHEMICAL
NAME: (1S,4S)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine 
hydrochloride. 
MOLECULAR FORMULA: C
17
H
17
Cl
2
N.HCl

MOLECULAR WEIGHT: 342.7 
CAS REGISTRY NUMBER: 79559-97-0 
INACTIVE:  cellulose microcrystalline, sodium starch glycollate
type-A, hydroxypropylcellulose, 
calcium hydrogen phosphate, magnesium stearate, and white opadry
(contains hypromellose, 
macrogol 400, titanium dioxide & polysorbate 80). 

DESCRIPTION 
Sertraline hydrochloride is a white crystalline powder that is
slightly soluble in water and isopropyl 
alcohol and sparingly soluble in ethanol. 

PHARMACOLOGY  
_MECHANISM OF ACTION _
Sertraline hydrochloride is an antidepressant for oral
administration. It is chemically unrelated to 
tricyclic, tetracyclic or other available antidepressant agents. 

The mechanism of action of sertraline is presumed to be linked
to its inhibition of central nervous 
system neuronal uptake of serotonin (5HT). Studies at clinically
relevant doses in humans 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 sertraline has no significant affinity for
adrenergic (alpha1, alpha2, beta), 
cholinergic, gamma-aminobutyric acid (GABA), dopaminergic,
histaminergic, serotonergic (5HT