VENLALIC XL 225 Milligram Tablet Prolonged Release
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
07-11-2017
Summary of Product characteristics
(SPC)
08-02-2018
Active ingredient:
VENLAFAXINE HYDROCHLORIDE
Available from:
DB Ashbourne Ltd
ATC code:
N06AX16
INN (International Name):
VENLAFAXINE HYDROCHLORIDE
Dosage:
225 Milligram
Pharmaceutical form:
Tablet Prolonged Release
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Other antidepressants
Authorization status:
Authorised
Authorization date:
2014-06-25
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
VENLALIC
® XL 37.5 MG PROLONGED-RELEASE TABLETS
VENLALIC
® XL 75 MG PROLONGED-RELEASE TABLETS
VENLALIC
® XL 150 MG PROLONGED-RELEASE TABLETS
VENLALIC
® XL 225 MG PROLONGED-RELEASE TABLETS
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 please 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 Venlalic XL is and what it is used for
2.
What you need to know before you take Venlalic XL
3.
How to take Venlalic XL
4.
Possible side effects
5.
How to store Venlalic XL
6.
Contents of the pack and other information
1.
WHAT VENLALIC XL IS AND WHAT IT IS USED FOR
Venlalic XL contains the active substance venlafaxine. Venlalic 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.
Venlalic XL is a treatment for adults with depression. Venlalic 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
ma
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Venlalic XL 225 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 225 mg venlafaxine (as
hydrochloride).
Excipient with known effect: lactose 6.5 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
11 mm round, biconvex, white tablets.
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 starting dose for prolonged-release venlafaxine is 75
mg given once daily. Patients not responding
to the initial 75 mg/day dose ma
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