Sertraline 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sertraline hydrochloride

Available from:

Relonchem 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: 05055144200798

Patient Information leaflet

ARTWORK LEGEND
PRODUCT NAME
PRODUCT LICENCE NO.
COMPONENT
DIMENSION
STRENGTH
PACK SIZE
FONT & SIZE
REMARKS
REASON FOR CHANGE
COUNTRY
MANUFACTURER
SOFTWARE
ARTIST
SERTRALINE FILM-COATED TABLETS
PL 20395/0276 - 0277
Pil
335 x 480 mm
50 mg & 100 mg
-
Humanst521 BT (12 pt, 9 pt)
-
Comments received from Tracey Chadwick on 02.08.2021
UK (English)
MARKSANS
Adobe illustrator CC
Gurukiran
NO. OF COLORS
01
██
Black
██ Dieline
3.3
VERSION
XXXXX
DATE
03.08.2021
297 mm
480 mm
38 mm
38 mm
297 mm
480 mm
Pharma Code
Pharma Code
If you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital
straight away.
You may find it helpful to tell a relative or close friend that you
are depressed or have an anxiety
disorder and ask them to read this leaflet. You might ask them to tell
you if they think your depression or
anxiety is getting worse or if they are worried about changes in your
behaviour.
CHILDREN AND ADOLESCENTS
Sertraline should not usually be used in children and adolescents less
than 18 years old, except for patients
with Obsessive Compulsive Disorder (OCD). Patients under 18 years have
an increased risk of undesirable
effects, such as suicide attempt, thoughts of harming or killing
themselves (suicidal thoughts) and hostility
(mainly aggressiveness, oppositional behaviour and anger) when they
are treated with this class of
medicines. Nevertheless, it is possible that your doctor decides to
prescribe Sertraline Tablets to a patient
under 18 years if it is in the patient's interest. If your doctor has
prescribed Sertraline Tablets to you and
you are less than 18 years old and you want to discuss this, please
contact him/her. Furthermore, if any of
the symptoms listed above appear or worsen while you are taking
Sertraline Tablets, you should inform
your doctor. Also, the long-term safety of Sertraline Tablets in
regard to growth, maturation and learning
(cognitive) and behavioural development in this age group has not yet
been demonstrated.
OTHER MEDICINES AND SERTRALINE TABLE

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sertraline 50 mg film-coated tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of sertraline (as
hydrochloride).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White, capsule shaped, biconvex, film-coated tablet debossed with SRN
and 50
on either side of break line and plain on other
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 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 adjustment depending on therapeutic response.
_Depression _
Longer-term treatment may also be appropriate for preven