Venlalic XL 300 mg prolonged-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Venlafaxine

Available from:

Ethypharm UK Ltd

ATC code:

N06AX; N06AX16

INN (International Name):

Venlafaxine

Dosage:

300 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Therapeutic area:

Other antidepressants; venlafaxine

Authorization date:

2019-07-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
VENLALIC XL 300 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, 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. 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 used to treat adults with depression. Treating
depression 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 VENLALIC XL
DO NOT TAKE VENLALIC XL
•
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
irreversible monoamine oxidase in

Summary of Product characteristics

Health Products Regulatory Authority
22 July 2019
CRN008LM3
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Venlalic XL 300 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 300 mg venlafaxine (as
hydrochloride).
Excipient with known effect: lactose 8.8 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
300 mg prolonged-release tablet, 12.8 mm round, biconvex, white tablet
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_
Venlalic XL 300 mg prolonged-release tablet is recommended for
patients not responding to the initial low doses of
venlafaxine.
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 300
mg/day dose and 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.
Lower strengths are available to facilitate dose titration when
initiating therapy and for individual dose adjustment.
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 sho