Sertraline 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sertraline hydrochloride

Available from:

Waymade Healthcare Plc

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

Patient Information leaflet

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sertraline 50mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of sertraline (as
hydrochloride).
Excipient(s) with known effect Each film-coated tablet contains 43.71
mg
lactose (as monohydrate) and 0.67 mg (0.029 mmol) sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, capsule shaped film-coated tablet scored on one
side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
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 dose regimen has been shown to
reduce
the frequency of early treatment emergent adverse reactions
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 _
Dose during long-term therapy should be kept at the lowest effective
level,
with subsequent
adjustment