VEDIXAL XL 150 Milligram Prolonged Release Capsules
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
18-10-2017
Summary of Product characteristics
(SPC)
18-10-2017
Active ingredient:
VENLAFAXINE HYDROCHLORIDE
Available from:
Milpharm Limited
ATC code:
N06AX16
INN (International Name):
VENLAFAXINE HYDROCHLORIDE
Dosage:
150 Milligram
Pharmaceutical form:
Prolonged Release Capsules
Administration route:
Oral use
Units in package:
7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 98 and 100 capsules
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic group:
Antidepressants, Other antidepressants
Therapeutic area:
Other antidepressants
Therapeutic indications:
Treatment of major depressive episodes. 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.
Authorization status:
Transfer Pending
Authorization date:
2015-03-06
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
VEDIXAL XL 37.5 MG PROLONGED-RELEASE CAPSULES, HARD
VEDIXAL XL 75 MG PROLONGED-RELEASE CAPSULES, HARD
VEDIXAL XL 150 MG 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 Vedixal XL is and what it is used for
2.
What you need to know before you take Vedixal XL
3.
How to take Vedixal XL
4.
Possible side effects
5.
How to store Vedixal XL
6.
Contents of the pack and other information
1.
WHAT VEDIXAL XL IS AND WHAT IT IS USED FOR
Vedixal XL contains the active substance venlafaxine.Vedixal 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.
Vedixal XL is a treatment for adults with depression. It is also a
treatment for adults with the
following anxiety disorders: generalised anxiety disorder, social
anxiety disorder (fear or avoidance of
social situations) and panic disorder (panic attacks). 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 t
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vedixal XL 150mg Prolonged release capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release capsule contains 150 mg of venlafaxine (as
hydrochloride).
Excipient with known effect
Each capsule contains 174.3 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard
White to off-white spherical to oval pellets filled in Empty hard
gelatin capsule shell (size ‘0’) of Opaque Dark orange
color cap and Opaque Dark orange color body imprinted with “E” on
cap and “89” on the body with edible black ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
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 same as the one used during the current
episode.
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