Sertraline Aurobindo 50mg flm-coated tablets

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

SERTRALINE HYDROCHLORIDE

זמין מ:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

קוד ATC:

N06AB06

INN (שם בינלאומי):

SERTRALINE HYDROCHLORIDE 50 mg

טופס פרצבטיות:

FILM-COATED TABLET

הרכב:

SERTRALINE HYDROCHLORIDE 50 mg

סוג מרשם:

POM

איזור תרפויטי:

PSYCHOANALEPTICS

מצב אישור:

Authorised

תאריך אישור:

2017-07-26

עלון מידע

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

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sertraline Aurobindo 50 mg film-coated tablets
Sertraline Aurobindo 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablets contains sertraline hydrochloride equivalent
to 50 mg sertraline
Each film-coated tablets contains sertraline hydrochloride equivalent
to 100 mg sertraline
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_Sertraline Aurobindo 50 mg_
_film-coated tablets _
White coloured, biconvex, capsule shaped film coated tablets, debossed
with ‘A’ on one side and with
a score line in between ‘8’ and ‘1’ on the other side. The
Size is: Approx. 10.5mm X 4.3mm.
The tablet can be divided into equal doses.
_ _
_Sertraline Aurobindo 100 mg_
_film-coated tablets _
White coloured, biconvex, capsule shaped film coated tablets, debossed
with ‘A’ on one side and ‘82’
on the other side. The Size is: Approx. 13.3mm X 5.3mm]
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 a