Venlofex 75 mg prolonged-release hard capsules

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:

75 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:

2008-10-17

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VENLOFEX 75 MG PROLONGED-RELEASE HARD CAPSULES
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 Venlofex is and what it is used for
2.
What you need to know before you take Venlofex
3.
How to take Venlofex
4.
Possible side effects
5.
How to store Venlofex
6.
Contents of the pack and other information
1.
WHAT VENLOFEX IS AND WHAT IT IS USED FOR
Venlofex contains the active ingredient venlafaxine, which 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.
Venlofex is a treatment for adults with depression or to prevent the
recurrence of major depressive
episodes. Venlofex 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 VENLOFEX
DO NOT TAKE VENLOFEX:
•
if you are allergic to venlafaxine or any of the other ingredients of
this medicine (listed in section
6).
•
if you are also taking or have taken any time within the last 14 days
any medicines known as
irreversibl

Summary of Product characteristics

Health Products Regulatory Authority
23 August 2023
CRN00DKLK
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Venlofex 75 mg prolonged-release hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains 84.86 mg of venlafaxine hydrochloride, equivalent
to 75 mg of venlafaxine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release hard capsule.
Opaque, flesh size 0 capsules, hard, marked with ‘VEN’ on the cap
of the capsule and ‘75’ on the body.
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
months following remission.
Generalised anxiety disorder
The recommended starti