Eleva

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

Sertraline hydrochloride

Dostępny od:

Alphapharm Pty Ltd

Klasa:

Medicine Registered

Ulotka dla pacjenta

ELEVA

_contains the active ingredient sertraline hydrochloride_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Eleva.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Eleva against the
benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT ELEVA IS USED FOR
Eleva is used to treat:
•
depression, panic disorder,
obsessive compulsive disorder
(OCD) and social phobia (social
anxiety disorder) in adults
•
premenstrual dysphoric disorder
(PMDD) in women
•
obsessive compulsive disorder
(OCD) in
-
children (aged 6-12 years),
and
-
adolescents (13-18 years).
Eleva 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.
PMDD affects some women in the
days before their period. PMDD is
different from premenstrual
syndrome (PMS). The mood
symptoms (e.g. anger, sadness,
tension) in PMDD are more severe
than in PMS and affect the woman's
daily activities and relationships with
others.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ELEVA HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Eleva for another reason.
Eleva 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
Eleva for the treatment of medical
conditions (other than OCD) in this
age group has not been satisfactorily
established.
For the treatment of OCD, Eleva is
not recommended for use in children
under the age of 6, as the safety and
eff

Charakterystyka produktu

ELEVA

_Sertraline hydrochloride _

PRODUCT INFORMATION 
NAME OF THE MEDICINE 
Active ingredient: 
Sertraline hydrochloride  
Chemical name: 
(1S,4S)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine 
hydrochloride. 
Structural formula: 

Molecular formula:  
C
17
H
17
NCl
2
.HCl 

Molecular weight: 
 342.7 
CAS Registry no.: 
 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  is  an  antidepressant  for  oral  administration.  It  is  chemically  unrelated  to  tricyclic,  tetracyclic  or 
other available antidepressant agents.  
Eleva 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 anhydrous, Sodium starch glycollate,
Magnesium stearate, Opadry II White Y-22-7719. 
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 

H

H

N

CH

3

Cl

Cl

H

.
HCl

ELEVA 
– Product Information 
2 

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