Serlan 100 mg Film-Coated Tablet

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Sertraline

Disponible des:

Rowex Ltd

Codi ATC:

N06AB; N06AB06

Designació comuna internacional (DCI):

Sertraline

Dosis:

100 milligram(s)

formulario farmacéutico:

Film-coated tablet

tipo de receta:

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

Área terapéutica:

Selective serotonin reuptake inhibitors; sertraline

Estat d'Autorització:

Marketed

Data d'autorització:

2005-03-11

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SERLAN 50 MG FILM-COATED TABLETS
SERLAN 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 Serlan is and what it is used for
2.
What you need to know before you take Serlan
3.
How to take Serlan
4.
Possible side effects
5.
How to store Serlan
6.
Contents of the pack and other information
1.
WHAT SERLAN IS AND WHAT IT IS USED FOR
Serlan 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.
SERLAN 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 b

Fitxa tècnica

Health Products Regulatory Authority
28 February 2024
CRN00DZLL
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Serlan 100 mg Film-Coated Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg sertraline as sertraline
hydrochloride.
Excipient(s) with known effect: Each tablet contains up to 1.58 mg
(0.069 mmol) sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, capsule shaped, scored film-coated tablets coded SE | 100 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 th