Sertral 100mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SERTRALINE

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

N06AB06

INN (International Name):

SERTRALINE 100 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

SERTRALINE 100 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Withdrawn

Authorization date:

2005-12-12

Patient Information leaflet

Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE USER
Sertral 50 mg film-coated tablets
Sertral 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 Sertralet is and what it is used for
2.
What you need to know before you take Sertralet
3.
How to take Sertralet
4.
Possible side effects
5.
How to store Sertralet
6.
Contents of the pack and other information
1.
WHAT SERTRALET IS AND WHAT IT IS USED FOR
Sertralet 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.
SERTRALET 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

Summary of Product characteristics

Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sertral 50 mg film-coated tablet
Sertral 100 mg film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
50 mg tablets
Each film-coated tablet contains sertraline hydrochloride equivalent
to 50 mg sertraline.
Excipient with known effect: Each film-coated tablet contains 19.8 mg
lactose monohydrate
_ _
100 mg tablets
Each film-coated tablet contains sertraline hydrochloride equivalent
to 100 mg sertraline.
Excipient with known effect: Each film-coated tablet contains 39.6 mg
lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
50 mg tablets
White to off-white, capsule-shaped, film-coated tablets, scored on one
side and printed with "50" on
the other. Size 4.2x10.3 mm. The tablet can be divided into equal
doses.
100 mg tablets
White to off-white, capsule-shaped, film-coated tablets, scored on one
side and printed with "100"
on the other. Size 5.2x13.1 mm. 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
Page 2 of 21
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