Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
ESCITALOPRAM
H. Lundbeck A/S
20 Milligram
Orodispersible Tablet
2010-09-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lexapro Meltz 20 mg orodispersible tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg escitalopram For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet White to off white, slightly speckled, flat-faced, round (12.7 mm), beveled edge tablet debossed with ENO on one side. 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 The safety of daily doses above 20 mg has not been demonstrated. Lexapro Meltz is administered as a single daily dose and should be taken without food. The tablet should be placed on the tongue, where it rapidly disintegrates and can be swallowed without water. The orodispersible tablet is fragile and should be handled carefully. The tablet does not have a tablet score line and cannot be divided into equal doses. The 5 mg dose should he administered in the form of film-coated tablets or oral drops, solution. The orodispersible tablet is the preferred dosage form for patients who have difficulties swallowing conventional tablets, or in situations in which liquids are not available. 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 init Lire le document complet