Efexor XL 75 mg prolonged-release capsules, hard

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Venlafaxine

Boleh didapati daripada:

IMED Healthcare Ltd.

Kod ATC:

N06AX; N06AX16

INN (Nama Antarabangsa):

Venlafaxine

Dos:

75 milligram(s)

Borang farmaseutikal:

Prolonged-release capsule, hard

Jenis preskripsi:

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

Kawasan terapeutik:

Other antidepressants; venlafaxine

Status kebenaran:

Authorised

Tarikh kebenaran:

2010-05-14

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
EFEXOR XL 75 MG PROLONGED-RELEASE CAPSULES, HARD
EFEXOR XL 150 MG PROLONGED-RELEASE CAPSULES, HARD
venlafaxine
IMPORTANT THINGS YOU SHOULD KNOW ABOUT EFEXOR XL
PLEASE READ ALL OF THIS LEAFLET BEFORE YOU START TO TAKE YOUR MEDICINE
AS IT CONTAINS IMPORTANT
INFORMATION ABOUT EFEXOR XL

EFEXOR XL IS USED TO TREAT DEPRESSION, SEVERE AND PERSISTENT ANXIETY
KNOWN AS GENERALISED ANXIETY DISORDER
(GAD), SOCIAL ANXIETY DISORDER (ALSO KNOWN AS SOCIAL PHOBIA) AND PANIC
DISORDER (PANIC ATTACKS)

EFEXOR XL IS NOT FOR USE IN CHILDREN AND ADOLESCENTS
– see in section 2 ‘Children and adolescents’
IF YOU HAVE ANY CONCERNS ABOUT HOW YOU FEEL, OR ABOUT THIS MEDICATION,
IT IS IMPORTANT THAT YOU TALK
TO YOUR DOCTOR - EVEN IF YOU FEEL ANXIOUS OR WORRIED ABOUT DOING SO.
You may find it helpful to tell a friend or relative that you are
depressed or suffering from an anxiety
disorder, and that you have been prescribed this medication; it might
be useful to show them this leaflet.

EFEXOR XL MAY NOT START TO WORK IMMEDIATELY.
Some people taking antidepressants may feel worse before feeling
better. Your doctor may ask to see you again a couple of weeks after
you start treatment and then regularly until you
start to feel well again. Tell your doctor if you do not start to feel
better.

SOME PEOPLE WHO ARE DEPRESSED MAY THINK OF HARMING OR KILLING
THEMSELF. IF THIS HAPPENS YOU SHOULD SEE YOUR
DOCTOR OR GO TO A HOSPITAL STRAIGHT AWAY
– see in section 2 ‘Thoughts of suicide and worsening of your
depression
or anxiety disorder’

IF YOU TAKE TOO MANY CAPSULES IT IS IMPORTANT TO SEEK IMMEDIATE
MEDICAL ATTENTION, EVEN IF YOU FEEL WELL,
BECAUSE OF THE RISK OF SERIOUS SIDE EFFECTS

DO NOT STOP TAKING EFEXOR XL OR CHANGE YOUR DOSE WITHOUT THE ADVICE OF
YOUR DOCTOR EVEN IF YOU FEEL BETTER.
If
you stop taking Efexor XL abruptly you may get withdrawal reactions
– see in section 3 ‘If you stop taking Efexor
XL’

IF YOU HAVE HEART PROBLEMS SUCH AS FAST OR IRREGULAR HEART RATE

Ciri produk

Health Products Regulatory Authority
15 November 2021
CRN00CKYZ
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Efexor XL 75 mg hard prolonged-release capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard prolonged-release capsule contains 84.85mg of venlafaxine
hydrochloride, equivalent to 75mg of venlafaxine free
base.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard prolonged-release capsule
_Product imported from Italy and the UK_
Opaque peach capsules printed in red with ‘W’ and ‘75’ hard
gelatine capsule
4 CLINICAL PARTICULARS
As per PA0822/072/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0822/072/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Capsule contents:_
Microcrystalline cellulose
Ethylcellulose
Hypromellose
Talc
_Capsule shell:_
Gelatin
Red and yellow Iron oxides (E172)
Titanium dioxide (E171)
_Capsule printing ink:_
Shellac
Red iron oxide (E172)
Ammonium hydroxide
Simeticone
Propylene glycol
6.2 INCOMPATIBILITIES
Not applicable
Health Products Regulatory Authority
15 November 2021
CRN00CKYZ
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 30
°
C
6.5 NATURE AND CONTENTS OF CONTAINER
A carton containing two blister strips (14 capsules per blister).
Pack size: 28 capsules
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/075/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 14th of May 2010
10 DATE OF REVISION OF THE TEXT
November 2021