Cipralex 15mg film coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ESCITALOPRAM

Available from:

H. Lundbeck A.S. 9 Ottiliavej, 2500 Valby, Copenhagen, Denmark

ATC code:

N06AB10

INN (International Name):

ESCITALOPRAM 15 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ESCITALOPRAM 15 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Withdrawn

Authorization date:

2006-11-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 

CIPRALEX
®
  5 MG FILM-COATED TABLETS 
CIPRALEX
®
 10 MG FILM-COATED TABLETS 
CIPRALEX
®
 20 MG FILM-COATED TABLETS 

ESCITALOPRAM  

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 Cipralex is and what it is used for 
2. 
What you need to know before you take Cipralex 
3. 
How to take Cipralex 
4. 
Possible side effects 
5. 
How to store Cipralex 
6. 
Contents of the pack and other information 

1. 
WHAT CIPRALEX IS AND WHAT IT IS USED FOR 
_ _
Cipralex contains the active substance escitalopram.  Cipralex
belongs to a group of 
antidepressants called selective serotonin reuptake inhibitors
(SSRIs). These medicines act 
on the serotonin-system in the brain by increasing the
serotonin level. Disturbances in the 
serotonin-system are considered an important factor in
the development of depression and 
related diseases. 

Cipralex contains escitalopram and is used to
treat depression (major depressive episodes) 
and anxiety disorders (such as panic disorder with or without
agoraphobia, social anxiety 
disorder, generalised anxiety disorder and
obsessive-compulsive disorder).  

It may take a couple of weeks before you start to
feel better. Continue to take Cipralex, even if 
it takes some time before you feel any improvement in your
condition. 

You must talk to a doctor if you do not

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
CIPRALEX
®
 5 mg film-coated tablets  
CIPRALEX
®
 10 mg film-coated tablets 
CIPRALEX
®
 20 mg film-coated tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Cipralex 5 mg: Each tablet contains 5 mg escitalopram (as oxalate) 
Cipralex 10 mg: Each tablet contains 10 mg escitalopram (as
oxalate) 
Cipralex 20 mg: Each tablet contains 20 mg escitalopram (as
oxalate) 
For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Cipralex 5 mg:  Round, white, film-coated tablet marked with "EK" on
one side. 
Cipralex 10 mg:  Oval, white, scored, film-coated tablet marked with
"E” and “L" on each 
side of the score on one side of the tablet. 
Cipralex 20 mg:  Oval, white, scored, film-coated tablet marked with
"E” and “N" on each 
side of the score on one side of the tablet. 
The 10 mg and 20 mg tablets can be divided into equal doses. 

4 CLINICAL 
PARTICULARS 
4.1 THERAPEUTIC 
INDICATIONS 
Treatment of major depressive episodes. 
Treatment of panic disorder with or without agoraphobia. 
Treatment of social anxiety disorder (social phobia). 
Treatment of generalised anxiety disorder. 
Treatment of obsessive-compulsive disorder. 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Safety of daily doses above 20 mg has not been demonstrated. 
Cipralex is administered as a single daily dose and may be taken
with or without food. 
Major depressive episodes 
Usual dosage is 10 mg once daily.  Depending on individual patient
response, the dose may 
be increased to a maximum of 20 mg daily. 
Page 1 of 18 
Usually 2-4 weeks are necessary to obtain antidepressant response.
 After the symptoms 
resolve, treatment for at least 6 months is required for
consolidation of the response. 
Panic disorder with or without agoraphobia 
An initial dose of 5 mg  is recommended for the first week before
increasing the dose to 10 
mg daily.  The dose may be further increased,