Sertraline 100 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sertraline

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

N06AB; N06AB06

INN (International Name):

Sertraline

Dosage:

100 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Selective serotonin reuptake inhibitors; sertraline

Authorization status:

Marketed

Authorization date:

2016-04-08

Patient Information leaflet

NL/H/3385/001-002/IB/031
, ver 02, Jan 2024
PACKAGE LEAFLET: INFORMATION FOR THE USER
SERTRALINE 50 MG FILM COATED TABLETS
SERTRALINE 100 MG FILM COATED TABLETS
sertraline
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
Sertraline tablets contain 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 TABLETS 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 s

Summary of Product characteristics

Health Products Regulatory Authority
16 January 2024
CRN00DVVK
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sertraline 100 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sertraline hydrochloride equivalent to 100 mg
sertraline.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White coloured, biconvex, capsule shaped, film coated tablets debossed
with ‘IJ’ on one side and plain on other side.
Tablet length is approximately 13.3 mm and width is approximately 5.2
mm.
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 effecti