Sertraline Actavis

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Sertraline hydrochloride 55.95mg equivalent to 50 mg Sertraline;  

Disponibil de la:

Teva Pharma (New Zealand) Limited

INN (nume internaţional):

Sertraline hydrochloride 55.95 mg (equiv to 50 mg Sertraline)

Dozare:

50 mg

Forma farmaceutică:

Film coated tablet

Compoziție:

Active: Sertraline hydrochloride 55.95mg equivalent to 50 mg Sertraline   Excipient: Calcium hydrogen phosphate Hyprolose Hypromellose Macrogol 400 Magnesium stearate Microcrystalline cellulose Polysorbate 80 Sodium starch glycolate Titanium dioxide

Tip de prescriptie medicala:

Prescription

Produs de:

Mylan Laboratories Limited

Indicații terapeutice:

Sertraline Actavis is indicated for the treatment of symptoms of depression, including depression accompanied by symptoms of anxiety, in patients with or without a history of mania. Following satisfactory response, continuation with sertraline therapy is effective in preventing relapse of the initial episode of depression or recurrence of further depressive episodes.

Rezumat produs:

Package - Contents - Shelf Life: Blister pack, PVC/Aluminium - 30 tablets - 48 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/Aluminium - 90 tablets - 48 months from date of manufacture stored at or below 25°C protect from light

Data de autorizare:

2014-08-27

Prospect

NEW ZEALAND CONSUMER MEDICINE INFORMATION
SERTRALINE ACTAVIS
Sertraline hydrochloride
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about SERTRALINE ACTAVIS.
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 ACTAVIS
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 ACTAVIS IS USED FOR
SERTRALINE ACTAVIS is used to treat depression and conditions called
obsessive compulsive disorder (OCD), panic disorder, post-traumatic
stress
disorder (PTSD), 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 ACTAVIS 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 ACTAVIS for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY SERTRALINE
ACTAVIS HAS BEEN PRESCRIBED FOR YOU.
SERTRALINE ACTAVIS 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 ACTAVIS for the treatment of medical conditions (other than
OCD) in this age group has not been satisfactorily established.
For the treatment of OCD, SERTRALINE ACTAVIS is not recommended for

Caracteristicilor produsului

NEW ZEALAND DATA SHEET
SERTRALINE ACTAVIS
Sertraline hydrochloride Tablets 50mg & 100mg
PRESENTATION
_Sertraline Actavis Tablets 50mg:_ White to off white, capsule shaped,
biconvex,
film-coated tablets with “50” and “BL” embossed on either side
of the breakline.
_Sertraline Actavis Tablets 100mg:_ White to off- white, capsule
shaped, biconvex,
film coated tablets with “100” and “BL” embossed on one side.
_Sertraline Actavis tablets include the following inert ingredients:_
Calcium
hydrogen phosphate anhydrous, microcrystalline cellulose,
hydroxypropyl
cellulose, sodium starch glycolate, magnesium stearate, hypromellose,
macrogol
400, titanium dioxide, polysorbate – 80.
“Do not halve the Sertraline Actavis 100mg tablet. Dose equivalence
when the
tablet is divided has not been established.”
USES
_ACTIONS _
Sertraline is a potent and selective inhibitor of neuronal serotonin
(5-HT) uptake
in vitro, which results in the potentiation of the effects of 5-HT in
animals. It has
only very weak effects on noradrenaline and dopamine neuronal
reuptake. At
clinical doses, sertraline blocks the uptake of serotonin into human
platelets. It is
devoid
of
stimulant,
sedative
or
anticholinergic
activity,
or
cardiotoxicity
in
animals. In controlled studies in normal volunteers, sertraline did
not cause
sedation and did not interfere with psychomotor performance. In accord
with its
selective
inhibition
of
5-HT
uptake,
sertraline
does
not
enhance
catecholaminergic activity. Sertraline has no affinity for muscarinic
(cholinergic),
serotonergic, dopaminergic, adrenergic, histaminergic, GABA or
benzodiazepine
receptors. The chronic administration of sertraline in animals was
associated with
downregulation of brain noradrenaline receptors as observed with other
clinically
effective antidepressants and antiobsessional drugs.
Sertraline has not demonstrated potential for abuse. In a
placebo-controlled,
double blind, randomised study of the comparative abuse liability of
sertraline,
alprazolam and d-amphetamine in human