Sertraline 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sertraline hydrochloride

Available from:

Zentiva Pharma UK Ltd

ATC code:

N06AB06

INN (International Name):

Sertraline hydrochloride

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030300; GTIN: 5000283631682

Patient Information leaflet

Depression is a clinical illness with symptoms like
feeling sad, unable to sleep properly or to enjoy life
as you used to.
• Social anxiety disorder (in adults).
Medicines are not always suitable for everyone. Tell
your doctor before you take Sertraline, if you suffer
from or have suffered in the past from any of the
following conditions:
• If you have or have previously had thoughts of
harming or killing yourself (see below-Thoughts of
suicide and worsening of your depression or
anxiety disorder).
Medicines like Sertraline (so called SSRIs/SNRIs)
may cause symptoms of sexual dysfunction (see
section 4). In some cases, these symptoms have
continued after stopping treatment.
• Obsessive compulsive disorder (OCD) (in adults and
children and adolescents aged 6-17 years old).
• If you have suffered from bleeding disorders or
have been taking medicines which thin the blood
(e.g. acetylsalicyclic acid (aspirin) or warfarin) or
may increase the risk of bleeding.
• If you are having electro-convulsive therapy
(ECT).
• If you have epilepsy (fit) or a history of seizures. If
you have a fit (seizure), contact your doctor
immediately.
Sertraline contains the active substance sertraline.
• Depression and prevention of recurrence of
depression (in adults).
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).
SERTRALINE CAN BE USED TO TREAT:
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).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
SERTRALINE
• Panic diso

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sertraline 100mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg of sertraline (as
hydrochloride).
Excipient(s) with known effect:
Each film-coated tablet contains 87.42 mg lactose (as monohydrate) and
1.34
mg (0.058 mmol) sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, capsule shaped 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 depending