ZOLOFT sertraline (as hydrochloride) 50 mg tablet blister pack

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

sertraline hydrochloride

Dostupno od:

Upjohn Australia Pty Ltd

Status autorizacije:

Registered

Uputa o lijeku

ZOLOFT
®
_Sertraline (sir-tra-leen) hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Zoloft.
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 Zoloft 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 ZOLOFT IS USED
FOR
Zoloft 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.
Zoloft 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
Zoloft for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ZOLOFT HAS
BEEN PRESCRIBED FOR YOU.
Zoloft 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
Zoloft for the treatment of medical
conditions (other than OCD) in this
age group has not been satisfactorily
established.
For the treatment of OCD, Zoloft is
not recommended for use in children
under the age of 6, as the safety and
efficacy in children of this age group
has not been established.
This medicine is only available with
a doctor's presc

Svojstava lijeka

Version: ujpzolot11020
Supersedes: pfpzolot10919
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AUSTRALIAN
PRODUCT
INFORMATION
–
ZOLOFT
 (SERTRALINE HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Sertraline hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZOLOFT 50 mg tablets contain 50 mg sertraline (as hydrochloride).
ZOLOFT 100 mg tablets contain 100 mg sertraline (as hydrochloride).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
ZOLOFT 50 mg capsule-shaped tablets: white film coated tablets
embossed with the Pfizer
logo on one side, and “ZLT” scoreline “50” on the other side.
ZOLOFT capsule-shaped 100 mg tablets: white film coated tablets
embossed with the Pfizer
logo on one side, and “ZLT 100” on the other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CHILDREN AND ADOLESCENTS
ZOLOFT (sertraline hydrochloride) is indicated for the treatment of
children (aged 6 years of
age and older) and adolescents with OCD.
ADULTS
ZOLOFT (sertraline hydrochloride) is indicated for the treatment of
major depression,
obsessive compulsive disorder (OCD) and panic disorder.
ZOLOFT (sertraline hydrochloride) is indicated for the treatment of
social phobia (social
anxiety disorder) and the prevention of its relapse.
ZOLOFT (sertraline hydrochloride) is indicated for the treatment of
premenstrual dysphoric
disorder (PMDD) as defined by DSM-IV criteria.
Version: ujpzolot11020
Supersedes: pfpzolot10919
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4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
CHILDREN AND ADOLESCENTS (6-18 YEARS)
_OBSESSIVE COMPULSIVE DISORDER _
The administration of ZOLOFT in children with OCD (ages 6-12 years) is
recommended to
commence at 25 mg/day (half a 50 mg tablet) for the first week and
then increasing to
50 mg/day. Adolescents (ages 13-18 years) may commence at 50 mg/day.
Clinical effects
may be noted after 2 weeks of treatment but clinical responses should
be monitored for 6 weeks
before any increase in dose. In children, a dose of 200 mg/day should
not be exceeded.
Sertraline has an elimination ha