Sertraline 100 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sertraline hydrochloride

Available from:

Accord Healthcare Limited

ATC code:

N06AB; N06AB06

INN (International Name):

Sertraline hydrochloride

Dosage:

100 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Selective serotonin reuptake inhibitors; sertraline

Authorization status:

Marketed

Authorization date:

2006-06-16

Patient Information leaflet

SERTRALINE 50 MG FILM-COATED TABLETS
SERTRALINE 100 MG FILM-COATED TABLETS
Sertraline
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 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).
• 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 is an illness linked to anxiety with symptoms like being
constantly
troubled by persistent ideas (obsessions) that make you carry out
repetitive rituals (compulsions).
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).
•

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sertraline 100 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100mg Sertraline (as hydrochloride)
Excipients with known effect: Each tablet contains 159.30mg of lactose
monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, scored, round biconvex, embossed with `C` on one side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide 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.
Obsessive compulsive disorder (OCD) in adults and paediatric patients
aged 6-17 years.
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.
_Titration_
_Depression and OCD_
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 prevention of
recurrence of major depressive episodes (MDE). In
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