Setrona

Country: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Sertraline hydrochloride 111.92mg equivalent to sertraline 100 mg;  ;  

Disponibbli minn:

Douglas Pharmaceuticals Limited

INN (Isem Internazzjonali):

Sertraline hydrochloride 111.92 mg (equivalent to sertraline 100 mg)

Dożaġġ:

100 mg

Għamla farmaċewtika:

Film coated tablet

Kompożizzjoni:

Active: Sertraline hydrochloride 111.92mg equivalent to sertraline 100 mg     Excipient: Calcium hydrogen phosphate dihydrate Hyprolose Magnesium stearate Microcrystalline cellulose Opadry white OY-S-58910 Sodium starch glycolate

Unitajiet fil-pakkett:

Blister pack, AL/PVC/PVDC, 30 tablets

Klassi:

Prescription

Tip ta 'preskrizzjoni:

Prescription

Manifatturat minn:

Sun Pharmaceutical Industries Ltd

Indikazzjonijiet terapewtiċi:

SETRONA is indicated for the treatment of paediatric patients (6- 17 years of age) with OCD. SETRONA is indicated for the treatment of obsessive-compulsive disorder (OCD).

Sommarju tal-prodott:

Package - Contents - Shelf Life: Blister pack, AL/PVC/PVDC - 30 tablets - 36 months from date of manufacture stored at or below 25°C

Data ta 'l-awtorizzazzjoni:

2005-03-18

Fuljett ta 'informazzjoni

CONSUMER MEDICINE INFORMATION
1
SETRONA
_sertraline (as hydrochloride) _
50 mg and 100 mg tablets
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING SETRONA.
This
leaflet
answers
some
common
questions
about
SETRONA.
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
SETRONA
against the benefits they expect it will 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 SETRONA IS USED FOR
SETRONA is used to treat:
•
Depression and prevention of recurrence of
depression (in adults).
•
Obsessive
compulsive
disorder
(OCD)
(in
adults and children and adolescents aged 6-
17 years old).
•
Panic disorder (in adults).
•
Post-traumatic
stress
disorder
(PTSD)
(in
adults).
•
Social anxiety disorder (in adults).
•
Premenstrual dysphoric disorder (PMDD) (in
adults).
SETRONA belongs to a group of medicines called
selective
serotonin
reuptake
inhibitors
(SSRIs).
They are thought to work by blocking the uptake
of serotonin (a chemical involved in controlling
mood) into nerve cells in the brain.
Your doctor may have prescribed SETRONA for
another reason. ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS
ABOUT
WHY
SETRONA
HAS
BEEN
PRESCRIBED FOR YOU.
This medicine is available only with a doctor's
prescription.
BEFORE YOU TAKE SETRONA
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE SETRONA IF YOU HAVE AN ALLERGY TO:
•
any medicine containing sertraline or
•
any of the ingredients listed at the end of this
leaflet.
Some of the symptoms of an allergic reaction may
include:
•
difficulty in breathing or wheezing.
•
shortness of breath.
•
swelling of the face, tongue, lips, or other parts
of the body.
•
hives on the skin, rash, or itching.
DO NOT TAKE SETRONA IF:
•
If
you are taking or
have
taken
medicines
called monoamine oxida

Karatteristiċi tal-prodott

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
SETRONA 50 mg film coated tablet
SETRONA 100 mg film coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 50 mg tablet contains sertraline hydrochloride 55.96 mg
(equivalent to sertraline 50 mg).
Each 100 mg tablet contains sertraline hydrochloride 111.92 mg
(equivalent sertraline 100 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
SETRONA 50 mg tablets are white film-coated caplet shaped tablets
embossed with ‘50’ on one
side and break line on the other.
SETRONA 100 mg tablets are white film-coated caplet shaped tablets
embossed with ‘100’ on one
side and break line on the other.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
CHILDREN AND ADOLESCENTS
SETRONA is indicated for the treatment of paediatric patients (6- 17
years of age) with obsessive-
compulsive disorder (OCD).
ADULTS
SETRONA
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.
SETRONA is indicated for the treatment of obsessive-compulsive
disorder (OCD). Following the
initial response, sertraline has been associated with sustained
efficacy, safety and tolerability for
up to 2 years of treatment of OCD.
SETRONA is indicated for the treatment of panic disorder, with or
without agoraphobia.
2 | P a g e
SETRONA is indicated for the treatment of post-traumatic stress
disorder (PTSD).
SETRONA 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 social phobia.
SETRONA is indicated for the treatment of premenstrual dysphoric
disorder (PMDD).
4.2.
DOSE AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
SETRON