Sertraline Bluefish 50 mg film-coated tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Sertraline hydrochloride

Saatavilla:

Bluefish Pharmaceuticals AB

ATC-koodi:

N06AB; N06AB06

INN (Kansainvälinen yleisnimi):

Sertraline hydrochloride

Annos:

50 milligram(s)

Lääkemuoto:

Film-coated tablet

Prescription tyyppi:

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

Terapeuttinen alue:

Selective serotonin reuptake inhibitors; sertraline

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

2013-05-24

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
SERTRALINE BLUEFISH 50 MG FILM-COATED TABLETS
SERTRALINE BLUEFISH 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Sertraline Bluefish is and what it is used for
2.What you need to know before you take Sertraline Bluefish
3. How to take Sertraline Bluefish
4. Possible side effects
5. How to store Sertraline Bluefish
6.Contents of the pack and other information
1. WHAT SERTRALINE BLUEFISH IS AND WHAT IT IS USED FOR
Sertraline Bluefish 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 Bluefish can be used in the treatment of:
-
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 sim

Valmisteyhteenveto

Health Products Regulatory Authority
11 April 2023
CRN00DHX9
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sertraline Bluefish 50 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains sertraline hydrochloride equivalent
to 50 mg sertraline
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
White capsule-shaped, film-coated tablets debossed with “A” on one
side and score line in between “8” and “1” on the other
side.
The score line 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.
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 du