Venex XL 225 mg Prolonged-release Capsules, hard
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
22-11-2019
Summary of Product characteristics
(SPC)
31-03-2021
Active ingredient:
Venlafaxine
Available from:
Clonmel Healthcare Ltd
ATC code:
N06AX; N06AX16
INN (International Name):
Venlafaxine
Dosage:
225 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:
Not marketed
Authorization date:
2017-11-10
Patient Information leaflet
Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
VENEX XL 37.5MG PROLONGED-RELEASE CAPSULES, HARD
VENEX XL 75MG PROLONGED-RELEASE CAPSULES, HARD
VENEX XL 150MG PROLONGED-RELEASE CAPSULES, HARD
Venex XL
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 Venex XL is and what is used for
2. What you need to know before you take Venex XL
3. How to take Venex XL
4. Possible side effects
5. How to store Venex XL
6. Contents of the pack and other information
1. WHAT VENEX XL IS AND WHAT IT IS USED FOR
Venex XL contains the active substance venlafaxine.
Venex 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.
Venex 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
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
30 March 2021
CRN00C41Z
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Venex XL 225 mg Prolonged-release Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 254.7 mg venlafaxine hydrochloride equivalent to
225 mg venlafaxine.
Excipients with known effect
Contains 0.02 mg carmoisine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard
Pink opaque / pink opaque, size ‘00’ hard gelatin capsules of
approximately 23.1 mm to 23.9 mm having thick and thin radial
circular band on the body in blue ink and thick and thin radial
circular band on the cap in blue ink. The capsule is filled with 18
white to off-white, round, biconvex, film coated mini tablets of 12.5
mg each.
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 epi
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