Sertraline 50mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Sertraline hydrochloride

Disponible depuis:

Sun Pharma UK Ltd

Code ATC:

N06AB06

DCI (Dénomination commune internationale):

Sertraline hydrochloride

Dosage:

50mg

forme pharmaceutique:

Oral tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 04030300; GTIN: 5015525193026

Notice patient

WHAT IS IN THIS LEAFLET
:
1.


What Sertraline is and what it is used for
2.


What you need to know before you take
Sertraline
3.


How to take Sertraline
4.


Possible side effects
5. How to store Sertraline
6.


Contents of the pack and other information
1.
WHAT SERTRALINE IS AND WHAT IT IS USED FOR
Sertraline contains the active substance sertraline.
Sertraline is one of a group of medicines called
Selective Serotonin Re-uptake Inhibitors (SSRIs);
these medicines are used to treat depression and/or
anxiety disorders.
SERTRALINE CAN BE 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,
speaking in front of groups of people, eating or
drinking in front of others or worrying that you
might behave in an embarrassing manner).
Your doctor has decided that this medicine is
suitable for treating your illness.
You should ask your doctor if you are unsure why
you have been given Sertraline.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
SERTRALINE
DO NOT TAKE SERTRALINE:
·
If you are
ALLERGIC
to
SERTRALINE
or any of the
other ingredients of this medicine (listed in
section 6).
·
If you are taking or have taken medicines

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sertraline 50 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 50 mg of sertraline as sertraline
hydrochloride.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
White film-coated caplet shaped tablet embossed with “50” on one
side and break-
line on the other side.
The tablet can be divided into equal doses.
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
Sertraline should be administered once daily, either in the morning or
evening.
Sertraline tablet can be administered with or without food.
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 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 ad