Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
VENLAFAXINE HYDROCHLORIDE
PCO Manufacturing
75 Milligram
Tablets
2002-02-22
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Efexor 75 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 75 mg of venlafaxine (as hydrochloride). Excipients: Lactose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM _Products imported from Spain:_ Peach coloured, oblong tablet, plain with a breakline on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Efexor is indicated for the treatment of depressive illness in both hospitalised patients and outpatients, including depression accompanied by anxiety. Following an initial response Efexor is 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 _Adults:_ The usual recommended dose is 75mg per day given in two divided doses (37.5mg twice daily). If, after several weeks, further clinical improvement is required, the dose may be increased to 150mg per day given in two divided doses (75mg twice daily). If, in the judgement of the physician, a higher dose is required, for example in more severely depressed or hospitalised patients, a starting dose of 150mg per day may be given in two divided doses (75mg twice daily). The daily dose may then be increased by up to 75mg every two or three days until the desired response is achieved. The maximum recommended dose is 375mg per day. The dose should then be gradually reduced to the usual dosage, consistent with patient response and tolerance. Usually, the dosage for prevention of relapse or for prevention of recurrence of a new episode is similar to that used during the index episode. Patients should be re-assessed regularly in order to evaluate the benefit of long-ter Przeczytaj cały dokument