Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Venlafaxine hydrochloride
Morningside Healthcare Ltd
N06AX; N06AX16
Venlafaxine hydrochloride
75 milligram(s)
Prolonged-release capsule
Product subject to prescription which may not be renewed (A)
Other antidepressants; venlafaxine
Not marketed
2008-08-15
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vensir XL 150mg prolonged release hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains venlafaxine hydrochloride equivalent to 150mg of venlafaxine One prolonged release capsule contains 0.3968 mg of Sunset yellow, see section 4.4 For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release capsules, hard. The capsules are dark orange / dark orange size ‘0’ hard gelatin capsules having thick and thin radial circular band on the body in white ink and thick and thin radial circular band on the cap in white ink. The capsule is filled with 12 white to off-white round biconvex film coated mini tablets of 12.5mg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The treatment of major depressive disorder 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 POSOLOGY 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 Pročitajte cijeli dokument
Health Products Regulatory Authority 02 December 2020 CRN009XR0 Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vensir XL 75 mg prolonged-release hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains venlafaxine hydrochloride equivalent to 75 mg of venlafaxine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release capsules, hard. The capsules are peach opaque / peach opaque size ‘1’ hard gelatin capsules having thick and thin radial circular band on the body in red ink and thick and thin radial circular band on the cap in red ink. The capsule is filled with 6 white to off-white round biconvex film coated mini tablets of 12.5 mg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The treatment of major depressive disorder 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 POSOLOGY 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 Pročitajte cijeli dokument