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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.
The tablet can be divided into equal halves.
Product imported from Italy:
Oval, white, scored, film-coated tablet marked with “E” and “N” on each side of the score on one side of the tablet.
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 mon
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