Sertraline 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sertraline hydrochloride

Available from:

Accord-UK Ltd

ATC code:

N06AB06

INN (International Name):

Sertraline hydrochloride

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030300; GTIN: 5060149311981 5055565757130

Patient Information leaflet

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 emotio

Summary of Product characteristics

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