Efexor XL 150 mg prolonged-release capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Venlafaxine

Available from:

PCO Manufacturing Ltd.

ATC code:

N06AX; N06AX16

INN (International Name):

Venlafaxine

Dosage:

150 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:

Authorised

Authorization date:

2003-06-03

Patient Information leaflet

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
EFEXOR
® XL 75 MG PROLONGED-RELEASE CAPSULES, HARD
EFEXOR
® XL 150 MG PROLONGED-RELEASE CAPSULES, HARD
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 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 norepinephrine in the
brain. It is not fully understood how
antidepressants work, but they may help by increasing the levels of
serotonin and norepinephrine 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 away and may become
more serious and more difficult to treat.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE

Summary of Product characteristics

Health Products Regulatory Authority
11 March 2020
CRN009MD8
Page 1 of 2
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 150 mg;
Each prolonged-release capsule contains 169.7mgof venlafaxine
hydrochloride, equivalent to 150mg of venlafaxine free base.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard
_Product imported from Spain, the UK and Portugal:_
Opaque dark-orange capsules printed in white with ‘W’ and
‘150’.
4 CLINICAL PARTICULARS
As per PA0822/072/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0822/072/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Capsule Contents:_
Microcrystalline cellulose
Ethylcellulose
Hypromellose
Talc
_Capsule Shell:_
Gelatin
Yellow iron oxide (E172)
Red iron oxide (E172)
Titanium dioxide (E171)
_Capsule Printing Ink:_
Shellac
Propylene glycol
Sodium hydroxide
Povidone
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
11 March 2020
CRN009MD8
Page 2 of 2
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Store in the original package.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs containing 28 or 30 capsules.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/085/004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10 DATE OF REVISION OF THE TEXT
March 2020