Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
VENLAFAXINE HYDROCHLORIDE
Ranbaxy (UK) Limited
VENLAFAXINE HYDROCHLORIDE
37.5 Milligram
Tablets
Product subject to prescription which may not be renewed (A)
Withdrawn
2010-11-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Venlift 37.5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 37.5mg venlafaxine (equivalent to 42.413mg of venlafaxine hydrochloride). For a full list of excipients, see section 6.1. Each tablet also contains lactose anhydrous. 3 PHARMACEUTICAL FORM Tablet Venlift 37.5mg Tablets are peach coloured, mottled, uncoated, shield shaped tablets debossed with ‘V’ and ‘2’ on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MAJOR DEPRESSIVE DISORDER Venlift 37.5mg Tablets are indicated for the treatment of major depressive disorder including depression accompanied by anxiety. Following an initial response Venlift 37.5mg Tablets are indicated for the prevention of relapses of the initial episode of depression or for the prevention of the recurrence of new episodes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Venlift 37.5mg Tablets should not be started until 14 days after discontinuing a monoamine oxidase inhibitor (MAOI). DEPRESSION: The recommended dose is 75mg per day given in two divided doses (37.5mg twice daily). Most patients respond to this dose. It is recommended that Venlift Tablets be taken with food and sufficient fluid at the same time of day. If, after an adequate trial and evaluation, further clinical improvement is required, the dose may be increased to 150mg per day given in two divided doses (75mg twice daily). There may be an increased risk of side effects at higher doses and dose increments should be made only after a clinical evaluation and after at least 3-4 weeks of therapy (see section 4.4). The lowest effective dose should be maintained. In more severely depressed or hospitalised patients, and under close sup Olvassa el a teljes dokumentumot