VENFAX XL 75 Milligram Prolonged Release Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

VENLAFAXINE HYDROCHLORIDE

Available from:

Rowex Ltd

ATC code:

N06AX16

INN (International Name):

VENLAFAXINE HYDROCHLORIDE

Dosage:

75 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:

2008-05-16

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VENFAX XL 37.5 MG PROLONGED-RELEASE CAPSULES, HARD
VENFAX XL 75 MG PROLONGED-RELEASE CAPSULES, HARD
VENFAX XL150 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 Venfax XL
is and what it is used for
2.
What you need to know before you take Venfax XL
3.
How to take Venfax XL
4.
Possible side effects
5.
How to store Venfax XL
6.
Contents of the pack and other information
1.
WHAT VENFAX XL IS AND WHAT IT IS USED FOR
Venfax 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.
Venfax 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 treat.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VENFAX XL
DO

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Venfax XL 75 mg Prolonged-Release Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release capsule, hard contains 75 mg venlafaxine (as
venlafaxine hydrochloride).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard.
Light pink coloured hard gelatin capsule containing white to off white
pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
For prevention of recurrence of major depressive episodes.
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. Dose 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.
_Generalised anxiety disorder_
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 225 mg/day. Dose increases
can be made at intervals of 2 we