Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
VENLAFAXINE HYDROCHLORIDE
Dallas Burston Ashbourne Ltd.
150 Milligram
Tablet Prolonged Release
2008-11-03
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Venlalic XL 150 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 150 mg venlafaxine (as hydrochloride) Excipient: lactose 5.7 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet. Round, biconvex, white tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of major depressive episodes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION MAJOR DEPRESSIVE EPISODES The recommended starting dose for prolonged-release venlafaxine is 75 mg given once daily. Patients not responding to the initial 75 mg/day dose may benefit from dose increases up to a maximum dose of 375 mg/day. Dosage increases can be made at intervals of 2 weeks or more. If clinically war ranted due to symptom severity, dose increases can be made at more frequent intervals, but not less than 4 days. Because of the risk of dose-related adverse effects, dose increments should be made only after a clinical evaluation (see section 4.4). The lowest effective dose should be maintained. Patients should be treated for a sufficient period of time, usually several months or longer. Treatment should be reassessed regularly on a case-by-case basis. Longer-term treatment may also be appropriate for prevention of recurrence of major depressive episodes (MDE). In most of the cases, the recommended dose in prevention of recurrence of MDE is the same as the one used during the current episode. Antidepressive medicinal products should continue for at least six months following remission. USE IN ELDERLY PATIENTS No specific dose adjustments of venlafaxine are considered necessary based on patient age alone. However, caution should be exercised in treati Lire le document complet