Sertraline Pfizer

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Sertraline hydrochloride

Available from:

Pfizer Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

SERTRALINE PFIZER
®

_Sertraline (sir-tra-leen) hydrochloride_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sertraline Pfizer.
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 Sertraline Pfizer 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 SERTRALINE
PFIZER IS USED FOR
Sertraline Pfizer 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.
Sertraline Pfizer 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
Sertraline Pfizer for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SERTRALINE
PFIZER HAS BEEN PRESCRIBED FOR YOU.
Sertraline Pfizer should not be used
in children and adolescents under the
age of 18 years for the treatment of
any medical condition other than
obsessive compulsive disorder
(OCD). The safety and efficacy of
Sertraline Pfizer for the treatment of
medical conditions (other than OCD)
in this age group has not been
satisfactorily established.
For the treatment of OCD, Sertraline
Pfizer is not recommended for use in
children under the age of 6,

Summary of Product characteristics

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PRODUCT INFORMATION 
SERTRALINE PFIZER
®
 (SERTRALINE HYDROCHLORIDE) 
NAME OF THE MEDICINE 
SERTRALINE PFIZER Sertraline (as hydrochloride) 50 mg and
100 mg capsules. 
SERTRALINE  PFIZER  is  an  antidepressant  for  oral  administration  and  contains  the  active 
ingredient  sertraline  hydrochloride.    Sertraline  hydrochloride  is  chemically  unrelated  to  tricyclic, 
tetracyclic or other available antidepressant agents. 
The structural formula of sertraline hydrochloride is shown
below: 

Chemical name: 
(1S,4S)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-
naphthalenamine hydrochloride 
Molecular formula: 
C
17
H
17
NCl
2
.HCl 
Molecular weight: 
342.7 
CAS Registry Number: 
79559-97-0. 
DESCRIPTION 
Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl 
alcohol and sparingly soluble in ethanol. 
SERTRALINE  PFIZER  is  supplied  for  oral  administration  as  film  coated  tablets  containing 
sertraline  hydrochloride  equivalent  to  50  and  100 mg  sertraline  and  the  following  inactive 
ingredients:  cellulose  –  microcrystalline,  calcium  hydrogen  phosphate,  hydroxypropyl  cellulose, 
sodium starch
glycollate, magnesium stearate, white Opadry, clear Opadry. 
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PHARMACOLOGY 
PHARMACODYNAMICS 
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 
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