ESCITALPRO 5 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ESCITALOPRAM OXALATE

Available from:

WPR Healthcare Limited

ATC code:

N06AB10

INN (International Name):

ESCITALOPRAM OXALATE

Dosage:

5 Milligram

Pharmaceutical form:

Film Coated Tablet

Administration route:

Oral use

Units in package:

Blister packs of 28 tablets

Prescription type:

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

Manufactured by:

Gerard Laboratories

Therapeutic group:

Antidepressants, selective serotonin reuptake inhibitors

Therapeutic area:

Selective serotonin reuptake inhibitors

Therapeutic indications:

Treatment of: major depressive episodes, panic disorder with or without agoraphobia, social anxiety disorder (social phobia), generalised anxiety disorder, obsessive-compulsive disorder

Authorization status:

Authorised

Authorization date:

2015-05-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 
ESCITALPRO 5 MG FILM-COATED TABLETS 
ESCITALPRO 10 MG FILM-COATED TABLETS 
ESCITALPRO 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. 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  

WHAT IS IN THIS LEAFLET  
1. What Escitalpro is and what it is used for  
2. What you need to know before you take Escitalpro  
3. How to take Escitalpro  
4. Possible side effects  
5. How to store Escitalpro . 
6. Contents of the pack and other information 

1. WHAT ESCITALPRO IS AND WHAT IT IS USED FOR  
Escitalpro belongs to a group of medicines called Selective
.Serotonin Re-uptake Inhibitor (SSRI) 
antidepressants. 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.  
Escitalpro can be given to treat the following conditions  
•  depression (major depressive episodes  
•  panic disorder which may or may not be associated with
agoraphobia (fear of open spaces) 
•  Social anxiety disorder  
•  Generalised anxiety disorder  
•  Obsessive-compulsive disorder 

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ESCITALPRO  
DO NOT TAKE ESCITALPRO:  
•  if you are allergic (hypersensitive) to
escitalopr

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Escitalpro 5mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Escitalpro 5 mg film-coated tablets: each tablet contains 5 mg escitalopram (as oxalate)
Excipient with known effect: 5 mg film-coated tablets contain lactose (as lactose monohydrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the UK:_
Escitalpro 5 mg film-coated tablets: round, white, film-coated tablet marked with "EC 5" on one side and “G” on the
other.
4 CLINICAL PARTICULARS
As per PA 0577/108/1
5 PHARMACOLOGICAL PROPERTIES
As per PA 0577/108/1
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Tablet core:_
Microcrystalline cellulose
Colloidal anhydrous silica
Talc
Croscarmellose sodium
Magnesium stearate
_Coating:_
Lactose monohydrate
Macrogol 4000
Titanium dioxide (E171)
Hypromellose
6.2 INCOMPATIBILITIES
Not applicable.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 05/05/2015_
_CRN 2159294_
_page number: 1_
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 25°C. Store in the original package.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 28 tablets contained in a cardboard carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
WPR Healthcare Limited
Unit 10
Ashbourne Business Park
Rath
Ashbourne
Co. Meath
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0565/055/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 1
st
of May