LEXAPRO 10 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ESCITALOPRAM OXALATE

Available from:

LTT Pharma Limited

INN (International Name):

ESCITALOPRAM OXALATE

Dosage:

10 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

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

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

•
Flow of milk in men and in women that are not  
nursing
•
Mania
•
An increased risk of bone fractures has been  
observed in patients taking this type of 
medicines
•
Alteration of the heart rhythm (called 
“prolongation of QT interval”, seen on ECG, 
electrical activity of the heart).
In addition, a number of side effects are known to
occur with drugs that work in a similar way to 
escitalopram (the active ingredient of Lexapro).
These are:
•
Motor restlessness (akathisia)
•
Loss of appetite
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly (see details below). By reporting
side effects you can help provide more information
on the safety of this medicine. Reports may be
made by following the links to the online reporting
option accessible from the IMB homepage, or by
completing the downloadable report form also 
accessible from the IMB website, which may be
completed manually and submitted to the IMB via
freepost, to the following address:
FREEPOST
Pharmacovigilance Section
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Tel: [phone]
Fax: [phone]
Website: www.imb.ie
e-mail: [e-mail]
5. HOW TO STORE LEXAPRO
Keep out of the sight and reach of children.
Do not use Lexapro after the expiry date, which is
stated on the label or carton after EXP.
The expiry date refers to the last day of that month.
This medicinal product does not require any 
special storage conditions.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER 
INFORMATION
WHAT LEXAPRO CONTAINS
The active substance is escitalopram. Each
Lexapro tablet contains 10 mg escitalopram 
(as oxalate).
The other ingredients are:
Core: microcrysta

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lexapro 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg escitalopram (as oxalate)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Romania_
Oval, white, scored, film-coated tablet marked with "E” and “L" on each side of the score on one side of the tablet.
The 10 mg 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