Vensir XL 75 mg prolonged-release hard capsules

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Venlafaxine hydrochloride

Dostupné z:

Morningside Healthcare Ltd

ATC kód:

N06AX; N06AX16

INN (Medzinárodný Name):

Venlafaxine hydrochloride

Dávkovanie:

75 milligram(s)

Forma lieku:

Prolonged-release capsule

Typ predpisu:

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

Terapeutické oblasti:

Other antidepressants; venlafaxine

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

2008-08-15

Príbalový leták

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

Súhrn charakteristických

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