SERTRALINE-DRLA sertraline 50 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Sertraline hydrochloride

Available from:

Dr Reddys Laboratories Australia Pty Ltd

INN (International Name):

Sertraline hydrochloride

Patient Information leaflet

SERTRALINE-DRLA CMI
1 of 9
V2
SERTRALINE-DRLA 50 MG AND
100 MG TABLETS
_Sertraline hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions
about Sertraline-DRLA tablets.
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-DRLA tablets against the benefits it is
expect 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-DRA TABLETS ARE USED FOR
Sertraline-DRLA tablets are 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 affects
the woman’s daily activities and relationships
with others.
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 Sertraline-
DRA for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS
ABOUT WHY SERTRALINE-DRLA TABLETS HAVE BEEN
PRESCRIBED FOR YOU.
This medicine is only available with a doctor’s
prescription.
There is no evidence that sertraline is addictive.
BEFORE YOU TAKE SERTRALINE-DRLA TABLETS
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE SERTRALINE-DRLA TABLETS IF
1.
you have ever had an allergic reaction to
sertraline or any of the ingredients listed at
the end of this leaflet.
SOME OF THE SYMPTOMS OF AN ALLERGIC
REACTION TO SERTRALINE-DR

Summary of Product characteristics

Page 1 of 20
Sertraline–DRLA tablets
Sertraline (as Hydrochloride)
Name of the Medicine
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
CAS number:
79559-97-0
Molecular weight:
342.7
Structural formula:
Description
Sertraline hydrochloride is a white crystalline powder that is
slightly soluble in water and
isopropyl alcohol and sparingly soluble in ethanol.
Sertraline-DRLA is an antidepressant for oral administration. It is
chemically unrelated to
tricyclic, tetracyclic or other available antidepressant agents.
Sertraline-DRLA tablets are supplied as film coated tablets containing
sertraline
hydrochloride equivalent to 50 and 100 mg sertraline.
Sertraline - DRLA tablets also contain the following excipients:
Microcrystalline cellulose,
calcium hydrogen phosphate, colloidal anhydrous silica, sodium starch
glycollate,
hydroxypropylcelluloase, magnesium stearate, Opadry complete film
coating system OY-
58900 White and polysorbate 80.
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 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 to adrenergic (α
1
, α
2
, β) cholinergic, GABA, dopaminergic, histaminergic,
serotonergic (5HT
1A
, 5HT
1B
, 5HT
2
) or benzodiazepine receptors; antagonism of such
receptors has been hypothesised to be associated with various
anticholinergic, sedative
_Sertraline-DRLA tablets _
_Dr Reddy’s Laboratories Australia Pty Ltd _
_Product Information _
_V3 _
_ _
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and cardiovascular effects for other psychotropic drugs. The c