Efexor XL 150 mg prolonged-release capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Venlafaxine hydrochloride

Available from:

Imbat Limited

ATC code:

N06AX; N06AX16

INN (International Name):

Venlafaxine hydrochloride

Dosage:

150 milligram(s)

Pharmaceutical form:

Prolonged-release capsule

Prescription type:

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

Therapeutic area:

Other antidepressants; venlafaxine

Authorization status:

Authorised

Authorization date:

2009-07-31

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
EFEXOR
® XL 150MG
PROLONGED-RELEASE CAPSULES, HARD
venlafaxine (as venlafaxine hydrochloride)
Your medicine is available using the above names, but will be
referred to as ‘Efexor XL’ throughout this leaflet.
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 Efexor XL is and what it is used for
2.
What you need to know before you take Efexor XL
3.
How to take Efexor XL
4.
Possible side effects
5.
How to store Efexor XL
6.
Contents of the pack and other information
1.
WHAT EFEXOR XL IS AND WHAT IT IS USED FOR
Efexor XL contains the active substance venlafaxine.
Efexor 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.
Efexor 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 aw

Summary of Product characteristics

Health Products Regulatory Authority
05 March 2020
CRN009MST
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Efexor XL 150 mg prolonged-release capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Efexor XL 150mg hard prolonged-release capsules contain 150mg of
venlafaxine as venlafaxine hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard.
_Product imported from Italy, Czech Republic & the UK._
Opaque dark orange capsules printed in white with ‘W’ on the cap
and ‘150' on the body.
4 CLINICAL PARTICULARS
As per PA0822/072/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0822/072/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Product imported from Italy:_
Microcrystalline cellulose
Ethylcellulose
Hypromellose
Gelatin
Yellow iron oxide (E172)
Red iron oxide (E172)
Titanium dioxide (E171)
Printing ink:
Shellac
Titanium dioxide (E171)
n-butyl alcohol
Isopropyl alcohol
Ethyl alcohol
Sodium hydroxide
Povidone
Propylene glycol
_Product imported from Czech Republic and the UK:_
Capsule contents:
Microcrystalline cellulose
Ethylcellulose
Hypromellose
Talc
Health Products Regulatory Authority
05 March 2020
CRN009MST
Page 2 of 3
Capsule shell:
Gelatin
Red and yellow iron oxides (E172)
Titanium dioxide (E171)
Capsule printing ink:
Shellac
Sodium hydroxide
Povidone
Titanium dioxide (E171)
Propylene glycol
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product is the date shown on the
blister strips and outer carton of the product as marketed in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
_Product imported from Italy_
Store in the original packaging. Do not store above 25
o
C.
_Product imported from Czech Republic:_
Do not store above 30
o
C. Store in the original package in order to protect from light and
moisture.
_Product imported from the UK:_
Do not store above 30
o
C.
6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer containing blister strips.
Pack size: