Arrow - Sertraline 100

Nazione: Nuova Zelanda

Lingua: inglese

Fonte: Medsafe (Medicines Safety Authority)

Principio attivo:

Sertraline hydrochloride 111.9mg ((Form-I) Equivalent to 100mg sertraline);  ;  ;  

Commercializzato da:

Teva Pharma (New Zealand) Limited

INN (Nome Internazionale):

Sertraline hydrochloride 111.9 mg ((Form-I) Equivalent to 100mg sertraline)

Dosaggio:

100 mg

Forma farmaceutica:

Film coated tablet

Composizione:

Active: Sertraline hydrochloride 111.9mg ((Form-I) Equivalent to 100mg sertraline)       Excipient: Calcium hydrogen phosphate Hyprolose Hypromellose Macrogol 400 Magnesium stearate Microcrystalline cellulose Polysorbate 80 Purified water Sodium starch glycolate Titanium dioxide

Confezione:

Blister pack, PVC/aluminium blisters, 90 tablets

Classe:

Prescription

Tipo di ricetta:

Prescription

Prodotto da:

Wanbury Limited

Indicazioni terapeutiche:

Arrow - Sertraline 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.

Dettagli prodotto:

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

Data dell'autorizzazione:

2004-09-17

Foglio illustrativo

NEW ZEALAND CONSUMER MEDICINE INFORMATION
ARROW - SERTRALINE
Sertraline hydrochloride
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about ARROW - 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 ARROW - 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 ARROW - SERTRALINE IS USED FOR
ARROW - SERTRALINE 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.
ARROW - 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 ARROW - SERTRALINE for another
purpose.
ASK
YOUR
DOCTOR
IF
YOU
HAVE
ANY
QUESTIONS
ABOUT
WHY
ARROW
-
SERTRALINE HAS BEEN PRESCRIBED FOR YOU.
ARROW - SERTRALINE 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
ARROW - SERTRALINE for the treatment of medical conditions (other than
OCD) in this age group has not been satisfactorily established.
For the treatment of OCD, ARROW - SERTRALINE is not recommended for

Scheda tecnica

Version 1.2
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1
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18
NEW ZEALAND DATA SHEET
1 NAME OF THE MEDICINE
Arrow – Sertraline 50, 50 mg, film coated tablets
Arrow – Sertraline 100, 100 mg, film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg or 100 mg of sertraline as sertraline
hydrochloride.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Tablets 50 mg: White to off-white, capsule shaped, biconvex, film
coated tablets with “50” and “BL”
embossed on either side of the breakline.
Tablets 100 mg: White to off-white, capsule shaped, biconvex, film
coated tablets with “100” and
“BL” embossed on one side.
Do not halve the Arrow - Sertraline 100 tablets. Dose equivalence when
the tablet is divided has not
been established.”
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CHILDREN AND ADOLESCENTS (6 – 17 YRS)
Arrow - Sertraline is indicated for the treatment of paediatric
patients (6 – 17 years of age) with
obsessive compulsive disorder (OCD).
ADULTS
Arrow - Sertraline 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.
Arrow - Sertraline is indicated for the treatment of obsessive
compulsive disorder. Following initial
response, sertraline has been associated with sustained efficacy,
safety and tolerability in up 2 years of
treatment of OCD.
Arrow - Sertraline is indicated for the treatment of panic disorder,
with or without agoraphobia.
Arrow - Sertraline is indicated for the treatment of post-traumatic
stress disorder (PTSD).
Arrow - Sertraline is indicated for the treatment of social phobia
(social anxiety disorder). Following
satisfactory response, continuation with sertraline therapy is
effective in preventing relapse of the
initial episode of soci