Vexarin XL 150 mg Prolonged-release capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Venlafaxine hydrochloride

Available from:

McDermott Laboratories Ltd t/a Gerard Laboratories

ATC code:

N06AX; N06AX16

INN (International Name):

Venlafaxine hydrochloride

Dosage:

150 milligram(s)

Pharmaceutical form:

Prolonged-release capsule

Prescription type:

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

Therapeutic area:

Other antidepressants; venlafaxine

Authorization status:

Not marketed

Authorization date:

2012-09-24

Patient Information leaflet

PAGE 2 OF 10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VEXARIN XL 75 MG PROLONGED-RELEASE CAPSULES, HARD
VEXARIN 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 Vexarin XL is and what it is used for
2.
What you need to know before you take Vexarin XL
3.
How to take Vexarin XL
4.
Possible side effects
5.
How to store Vexarin XL
6.
Contents of the pack and other information
1.
WHAT VEXARIN XL IS AND WHAT IT IS USED FOR
VEXARIN XL CONTAINS THE ACTIVE SUBSTANCE VENLAFAXINE.
_ _
Vexarin 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.
Vexarin XL is a treatment for adults with depression. Vexarin XL 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 treat.
2.
WHAT YOU NEED TO KNOW

Summary of Product characteristics

Health Products Regulatory Authority
18 January 2019
CRN008L86
Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vexarin XL 150 mg Prolonged-release capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release capsule, hard contains 150 mg of venlafaxine
(as
hydrochloride).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard
Size 0, hard, gelatine capsule with opaque dark orange cap and body,
axially printed
with “MYLAN” over “VE150” in 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.
Health Products Regulatory Authority
18 January 2019
CRN008L86
Page 2 of 22
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.
Antidepressive medicinal products should continu