Vensir XL 150 mg prolonged-release hard capsules

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

इसे खरीदें

सक्रिय संघटक:

Venlafaxine hydrochloride

थमां उपलब्ध:

Morningside Healthcare Ltd

ए.टी.सी कोड:

N06AX; N06AX16

INN (इंटरनेशनल नाम):

Venlafaxine hydrochloride

डोज़:

150 milligram(s)

फार्मास्यूटिकल फॉर्म:

Prolonged-release capsule

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may not be renewed (A)

चिकित्सीय क्षेत्र:

Other antidepressants; venlafaxine

प्राधिकरण का दर्जा:

Not marketed

प्राधिकरण की तारीख:

2008-08-15

सूचना पत्रक

                                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
                                
                                पूरा दस्तावेज़ पढ़ें
                                
                            

उत्पाद विशेषताएं

                                Health Products Regulatory Authority
02 December 2020
CRN009XR0
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vensir XL 150 mg prolonged-release hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains venlafaxine hydrochloride equivalent to 150 mg
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 12.5 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 (MD
                                
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