Sertraline 50mg tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Sertraline hydrochloride

Tilgængelig fra:

Medreich Plc

ATC-kode:

N06AB06

INN (International Name):

Sertraline hydrochloride

Dosering:

50mg

Lægemiddelform:

Oral tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 04030300; GTIN: 5060292740690

Indlægsseddel

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 any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sertraline Tablets are and what they are used for
2.
What you need to know before you take Sertraline Tablets
3.
How to take Sertraline Tablets
4.
Possible side effects
5.
How to store Sertraline Tablets
6.
Contents of the pack and other information
1. WHAT SERTRALINE TABLETS ARE AND WHAT THEY ARE USED FOR
Sertraline is one of a group of medicines called the Selective
Serotonin Reuptake
Inhibitors (SSRIs); these medicines are used to treat depression
and/or anxiety disorders.
Sertraline is used to treat
•
Depression and prevention of recurrence of depression (in adults)
•
Social anxiety disorder (in adults)
•
Post Traumatic Stress Disorder (PTSD) (in adults).
•
Panic disorder(in adults).
•
Obsessive Compulsive Disorder (OCD) (in adults and children and
adolescents
aged 6 – 17 years old).
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 characterised
by feelings of intense anxiety or distress in social situations (for
example: talking to
strangers

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sertraline 50 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Sertraline hydrochloride equivalent to 50 mg
sertraline.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablets.
50 mg white, oblong, biconvex, film-coated tablet with score line on
one face.
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
Posology
_Initial Treatment_
_Depression and OCD _
Sertraline treatment should be started at a dose of 50 mg/day.
_Panic Disorder, PTSD, and Social Anxiety Disorder _
Therapy should be initiated at 25 mg/day. After one week, the dose
should be
increased to 50 mg 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 50 mg dose may benefit from dose
increases.
Dose changes should be made in steps of 50 mg at intervals of at least
one week, up
to a maximum of 200 mg/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 depending on therapeutic response.
_Depression _
Longer-term treatment may also be appropriate for prevention of
recurrence of major
depressive
episodes
(MDE).
In
most
of
the
cases