Sertraline 50mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Sertraline hydrochloride

Disponible depuis:

Dowelhurst 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

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 called M

Résumé des caractéristiques du produit

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 excipients, see 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
Sertraline 50 mg and 100 mg Tablets should be given as a single daily
dose
either in the morning or evening. Sertraline Tablets can be
administered with
or without food.
Sertraline tablets are for oral administration only
ADULTS:
_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 a