Lexapro 20mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Escitalopram

Available from:

Imbat Limited

ATC code:

N06AB; N06AB10

INN (International Name):

Escitalopram

Dosage:

20 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Selective serotonin reuptake inhibitors; escitalopram

Authorization status:

Authorised

Authorization date:

2009-06-25

Patient Information leaflet

_Page 1 of 2 _
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEXAPRO
® 5MG FILM-COATED TABLETS
LEXAPRO
® 10MG FILM-COATED TABLETS
LEXAPRO
® 15MG FILM-COATED TABLETS
LEXAPRO
® 20MG FILM-COATED TABLETS
escitalopram (as oxalate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE

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 symptoms are the
same as yours.

If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.
_ _
In this leaflet_: _
1.
What Lexapro is and what it is used for
2.
Before you take Lexapro
3.
How to take Lexapro
4.
Possible side effects
5.
How to store Lexapro
6.
Further information
1.
WHAT LEXAPRO IS AND WHAT IT IS USED
FOR
Lexapro 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.
Lexapro 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.
BEFORE YOU TAKE LEXAPRO
DO NOT TAKE LEXAPRO

if you are allergic (hypersensitive) to escitalopram or any of
the other ingredients of Lexapro (see section 6 “Further
information”).

if you take other medicines that belong to a group called
MAO inhibitors, including selegiline (used in the treatment of
Parkinson’s disease), moclobemide (used in the treatment of
depression) and linezolid (an antibiotic).

if you are born with or have had an episode of abnormal
heart rhythm (seen at ECG: an examination to evalua

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lexapro 20mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20mg escitalopram (as oxalate)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from the UK and Spain:_
Oval, white, scored, film-coated tablet marked with ‘E’ and
‘N’ on each side of the score on one side of the tablet and
plain on the other.
The tablet can be divided into equal halves.
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.
Lexapro 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.
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, up to a maximum of 20 mg daily, dependent on
individual patient response.
Maximum effectiveness is reached after about 3 months. The treatment
lasts several months.
Social anxiety disorder
Usual dosage is 10 mg once daily. Usually 2-4 weeks are necessary to
obtain symptom relief. The dose may
subsequently, depending on individual patient response, be decreased
to 5 mg or increased to a maximum of 20 mg
daily.
Social anxiety disorder is a disease with a chronic course, and
treatment for 12 weeks is recommended to consolidate
response. Lo