Sertraline 50mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Sertraline hydrochloride

Prieinama:

Kent Pharma (UK) Ltd

ATC kodas:

N06AB06

INN (Tarptautinis Pavadinimas):

Sertraline hydrochloride

Dozė:

50mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 04030300

Pakuotės lapelis

0006 -CCRF22112 & 21147-1
PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
SERTRALINE HYDROCHLORIDE 50 MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet you may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
•
If you get any of the side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See Section 4.
Sertraline Tablets contain the active substance Sertraline. Sertraline
Tablets is one of a group of medicines
called selective serotonin reuptake inhibitors (SSRIs). These work by
bringing the level of serotonin in the
brain, back up to normal. Low levels of serotonin are thought to be a
cause of depression and related
disorders.
Sertraline can be used to treat:
•
Depression and prevention of recurrence of depression in adults
•
Social anxiety disorder in adults
•
Obsessive-compulsive disorder (OCD) in adults, children and
adolescents aged 6 - 17 years
•
Post traumatic stress disorder (PTSD) in adults
•
Panic disorder in adults, with or without agoraphobia
Depression is a clinical illness with symptoms like feeling sad,
unable to sleep properly or to enjoy life as you
used to.
OCD and Panic disorders are illnesses linked to anxiety with symptoms
like being constantly troubled by
persistent ideas (obsessions) that make you carry out repetitive
rituals (compulsions).
PTSD is a condition that can occur after a very emotionally traumatic
experience and has some symptoms
that are similar to depression and anxiety.
Social anxiety disorder (social phobia) is an illness linked to
anxiety. It is characterized by feelings of intense
anxiety or distress in social situations (for example talking to
strangers, speaking in front of groups of people,

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sertraline 50 mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg sertraline (as hydrochloride).
For excipients, see 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White capsular shaped tablet with a breakline and ‘SRN 50’
embossed on one
side and ‘NEO’ embossed on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sertraline is indicated for the treatment of:
Major depressive episodes. Prevention of recurrence of major
depressive
episodes.
Panic disorder, with or without agoraphobia.
Obsessive compulsive disorder (OCD) in adults and paediatric patients
aged 6-17 years.
Social anxiety disorder.
Post traumatic stress disorder (PTSD).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Sertraline should be given as a single daily dose either in the
morning or
evening. Sertraline tablets can be administered with or without food.
_Initial treatment _
_ _
_Depression and OCD _
Sertraline treatment should be started at a dose of 50mg/day.
_Panic Disorder, PTSD, and Social Anxiety Disorder _
Therapy should be initiated at 25mg/day. After one week, the dose
should be
increased to 50mg once daily. This dosage regimen has been shown to
reduce
the frequency of early treatment emergent side effects characteristic
of panic
disorder.
_Titration _
_Depression, OCD, Panic Disorder, Social Anxiety Disorder and PTSD _
Patients not responding to a 50mg dose may benefit from dose
increases. Dose
changes should be made in steps of 50mg at intervals of at least one
week, up
to a maximum of 200mg/day. Changes in dose should not be made more
frequently than once per week given the 24-hour elimination half life
of
sertraline.
The onset of therapeutic effect may be seen within 7 days. However,
longer
periods are usually necessary to demonstrate therapeutic response,
especially
in OCD.
_Maintenance _
Dosage during long-term therapy should be kept at the lowest effective
level,
with subsequent adjustment de