Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
VENLAFAXINE HYDROCHLORIDE
IPS Healthcare Limited
150 Milligram
Prolonged Release Capsules
2010-11-19
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Efexor XL 150mg Prolonged - release capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Efexor XL 150mg prolonged-release hard capsule contains 150mg of venlafaxine as venlafaxine hydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release capsule, hard _Product imported from the United Kingdom:_ Opaque dark orange capsules printed in white with ‘W’ and ’150’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive episodes. For prevention of recurrence of major depressive episodes. Treatment of generalised anxiety disorder. Treatment of social anxiety disorder. Treatment of panic disorder, with or without agoraphobia. 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 warranted 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 t Read the complete document