Venlafex XL 150 mg prolonged-release capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Venlafaxine hydrochloride

Available from:

KRKA, d.d., Novo mesto

ATC code:

N06AX; N06AX16

INN (International Name):

Venlafaxine hydrochloride

Dosage:

150 milligram(s)

Pharmaceutical form:

Prolonged-release capsule, hard

Prescription type:

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

Therapeutic area:

Other antidepressants; venlafaxine

Authorization status:

Marketed

Authorization date:

2010-11-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
VENLAFEX XL 37.5 MG PROLONGED-RELEASE CAPSULES, HARD
VENLAFEX XL 75 MG PROLONGED-RELEASE CAPSULES, HARD
VENLAFEX 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, pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
_ _
WHAT IS IN THIS LEAFLET
1.
What Venlafex XL is and what it is used for
2.
What you need to know before you take Venlafex XL
3.
How to take Venlafex XL
4.
Possible side effects
5.
How to store Venlafex XL
6.
Contents of the pack and other information
1.
WHAT VENLAFEX XL IS AND WHAT IT IS USED FOR
Venlafex XL contains the active substance venlafaxine.
Venlafex 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.
Venlafex 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 difficu

Summary of Product characteristics

Health Products Regulatory Authority
27 March 2024
CRN00F61J
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Venlafex XL 150 mg prolonged-release capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release capsule, hard, contains 150 mg venlafaxine (as
169.70 mg venlafaxine hydrochloride).
Excipient(s) with known effect:
150 mg capsule
sucrose
130 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard.
Opaque, brownish-orange, prolonged-release, hard gelatine capsules
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.
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.
Antidepressive medicinal products should continue for at least six
mont