Sertraline 50mg tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Sertraline hydrochloride

Tersedia dari:

Mawdsley-Brooks & Company Ltd

Kode ATC:

N06AB06

INN (Nama Internasional):

Sertraline hydrochloride

Dosis:

50mg

Bentuk farmasi:

Oral tablet

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 04030300

Selebaran informasi

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
This medicine is one of a group of antidepressant or anti-obsessional
drugs called
the Selective Serotonin Reuptake Inhibitors (SSRIs).
Sertraline is used to treat depression and prevention of recurrence of
depression, Panic
disorder, Obsessive Compulsive Disorder (OCD), Social anxiety disorder
or Post
Traumatic Stress Disorder (PTSD). It is also used to treat OCD in
children and
adolescents aged 6 – 17 years old.
Your doctor has decided that this medicine is suitable for treating
your illness.
Depression is a clinical illness. If you have been feeling sad,
tearful, unable to sleep
properly or to enjoy life as you used to, Sertraline Tablets may help
you to feel better.
It may also help treat the anxiety which may accompany your
depression. If you are
not sure why you are on these tablets, ask your doctor.
OCD and Panic disorders are illnesses linked to anxiety. If you have
been constantly
troubled by persistent ideas (obsessions) that make you carry out
repetitive rituals
(compulsions) Sertraline Tablets may help you. If you are not sure why
you are on
these tablets, ask your doctor.
PTSD is a condition that can occur after a very emot

Karakteristik produk

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