Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
ESCITALOPRAM OXALATE
Genthon B.V.
20 Milligram
Film Coated Tablet
2010-10-15
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Escitomar 20 mg 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 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. Film-coated tablet (tablet) White, oval, film-coated tablets, debossed with ‘E9CM’ on one side and on the other side scored and debossed with ‘20’ (one number on each side of the scoring line). The tablets can be divided into equal halves. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _ Baca dokumen lengkapnya