VENEX XL 150 Milligram Prolonged Release Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

VENLAFAXINE HYDROCHLORIDE

Available from:

Clonmel Healthcare Ltd

ATC code:

N06AX16

INN (International Name):

VENLAFAXINE HYDROCHLORIDE

Dosage:

150 Milligram

Pharmaceutical form:

Prolonged Release Capsules

Prescription type:

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

Therapeutic area:

Other antidepressants

Authorization status:

Authorised

Authorization date:

2008-10-17

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
VENEX XL 37.5MG PROLONGED-RELEASE CAPSULES, HARD
VENEX XL 75MG PROLONGED-RELEASE CAPSULES, HARD
VENEX XL 150MG PROLONGED-RELEASE CAPSULES, HARD
Venlafaxine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Venex XL is and what it is used for
2.
What you need to know before you take Venex XL
3.
How to take Venex XL
4.
Possible side effects
5.
How to store Venex XL
6.
Contents of the pack and other information
1. WHAT VENEX XL IS AND WHAT IT IS USED FOR
Venex XL contains the active substance venlafaxine.
Venex
XL
is
an
antidepressant
that
belongs
to
a
group
of
medicines
called
serotonin
and
norepinephrine reuptake inhibitors (SNRIs). This group of medicines is
used to treat depression and
other conditions such as anxiety disorders. It is thought that people
who are depressed and/or anxious
have lower levels of serotonin and noradrenaline in the brain. It is
not fully understood how
antidepressants work, but they may help by increasing the levels of
serotonin and noradrenaline in the
brain.
Venex XL is a treatment for adults with depression. It is also a
treatment for adults with the following
anxiety disorder: social anxiety disorder (fear or avoidance of social
situations). Treating depression or
anxiety disorders properly is important to help you get better. If it
is not treated, your condition may
not go away and may become more serious and more difficult to treat.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VENEX XL
DO NOT TAKE VENEX XL

If you are aller

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Venex XL 150 mg prolonged-release capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains venlafaxine hydrochloride, equivalent to 150 mg
of venlafaxine.
Excipients
sucrose max. 185.38 mg
sunset yellow FCF (E110) 0.0183 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release capsule, hard.
White to off-white granules in a capsule size “0” with a buff cap
and transparent body.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
For prevention of recurrence of major depressive episodes.
Treatment of social anxiety disorder.
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 same as the one used during the current
episode.
Anti-depressive medicinal products should continue for at least six
months following remission.
Social anxiety disorder
The recommended dose for prolonged-release venlafaxine is 75 mg given
once daily. There is no evidence that higher
doses confer any additional benefit.
However, in i