Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
VENLAFAXINE HYDROCHLORIDE
Pinewood Laboratories Ltd,
75 Milligram
Prolonged Release Capsules
2008-12-02
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Efaxil XL 75 mg Prolonged-release Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release capsule contains 75mg of venlafaxine as venlafaxine hydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release Capsule. Flesh opaque/flesh opaque, size 0 hard gelatin capsules containing two white round, biconvex film-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive episodes. For prevention of recurrence of major depressive episodes. Treatment of social anxiety disorder. 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 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. _SOCIAL AN Read the complete document