Escitalopram 5mg Film-Coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ESCITALOPRAM

Available from:

Cipla (EU) Limited Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom

ATC code:

N06AB10

INN (International Name):

ESCITALOPRAM 5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ESCITALOPRAM 5 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Withdrawn

Authorization date:

2013-11-14

Patient Information leaflet

KS75 A
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESCITALOPRAM 5 MG FILM-COATED TABLETS
ESCITALOPRAM 10 MG FILM-COATED TABLETS
ESCITALOPRAM 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
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 or pharmacist
or nurse. This includes any possible 
side effects not listed in this leaflet.

WHAT IS IN THIS LEAFLET

1. What this medicine is and what it is used for.

2. Before you take this medicine

3. How to take this medicine

4. Possible side effects

5. How to store this medicine

6. Contents of the pack and other information
  1.  WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
This medicine 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.  
This medicine 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).  
  2.  WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS MEDICINE
DO NOT TAKE THIS MEDICINE:
  If you are allergic (hypersensitive) to escitalopram or
any of the other ingredients of this medicine (see section  
  6 “Contents of the pack and other information”). 
  If you take other medicines that belongs to a group
called MAO inhibitors, including sele

Summary of Product characteristics

Page 1 of 18 
SUMMARY OF PRODUCT CHARACTERISTICS 

1.  
NAME OF THE MEDICINAL PRODUCT 

Escitalopram 5 mg Film-Coated Tablets 

Escitalopram 10 mg Film-Coated Tablets 

Escitalopram 20 mg Film-Coated Tablets 

2.  
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Escitalopram 5 mg Film-Coated Tablets: Each tablet contains 5
mg escitalopram (as oxalate) 

Escitalopram 10 mg Film-Coated Tablets: Each tablet contains 10
mg escitalopram (as oxalate) 

Escitalopram 20 mg Film-Coated Tablets: Each tablet contains 20
mg escitalopram (as oxalate) 

For a full list of excipients, see section 6.1. 

3.  
PHARMACEUTICAL FORM 

Film-Coated Tablet 

Escitalopram 5 mg: White to off white, round, biconvex
film coated tablets with “E5” debossed on 
one side and plain on the other side. Diameter- 6.00 mm to 6.20 mm. 

Escitalopram 10 mg: White to off white, round, biconvex film coated
tablets with “E10” debossed 
on one side and break line on the other side. The 10 mg tablets can
be divided into equal halves. 
Diameter- 7.50 mm to 7.70 mm. 

Escitalopram 20 mg: White to off white, round, biconvex film coated
tablets with “E20” debossed 
on one side and break line on the other side. The 20 mg tablets can
be divided into equal halves. 
Diameter- 9.50 mm to 9.70 mm. 

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 
Page 2 of 18 
4.2  
POSOLOGY AND METHOD OF ADMINISTRATION 

Safety of daily doses above 20 mg has not been demonstrated. 

Escitalopram Tablets 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