Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ESCITALOPRAM
Pfizer Healthcare Ireland
20 Milligram
Film Coated Tablet
2011-08-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Escitalopram Pfizer 20mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg escitalopram (as oxalate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off – white colored, oval shaped, film-coated, biconvex tablets debossed with ‘F’ on one side and ‘56’ on the other side with a deep scoreline between ‘5’ and ‘6’. The tablets 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. Escitalopram 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 sym Read the complete document