Efexor XL 75 mg prolonged-release capsules, hard

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Venlafaxine

Disponible desde:

PCO Manufacturing Ltd.

Código ATC:

N06AX; N06AX16

Designación común internacional (DCI):

Venlafaxine

Dosis:

75 milligram(s)

formulario farmacéutico:

Prolonged-release capsule, hard

tipo de receta:

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

Área terapéutica:

Other antidepressants; venlafaxine

Estado de Autorización:

Authorised

Fecha de autorización:

2003-06-03

Información para el usuario

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
EFEXOR
® XL 75 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 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 EFEXOR XL
DO NOT TAKE EFEXOR 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

Ficha técnica

Health Products Regulatory Authority
23 October 2023
CRN00DV8Q
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Efexor XL 75 mg prolonged-release capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Efexor XL 75 mg;
Each prolonged-release capsule contains 84.85 mg of venlafaxine
hydrochloride, equivalent to 75 mg 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, France, Italy and Greece:
Opaque peach capsules printed in red with ‘W’ and ‘75’ hard
gelatin capsule, size 1
4 CLINICAL PARTICULARS
As per PA23355/002/002
5 PHARMACOLOGICAL PROPERTIES
As per PA23355/002/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Product imported from France, Spain, and Italy contains
Microcrystalline cellulose
Ethylcellulose
Hypromellose
Gelatin
Yellow iron oxide (E172)
Red iron oxide (E172)
Titanium dioxide (E171)
Product from France also contains
Black iron Oxide (E172)
Product from Spain also contains
Printing ink (shellac, propylene glycol, povidone, sodium hydroxide,
titanium dixoide)
Product from Greece contains
_Capsule contents_
Microcrystalline cellulose
Ethylcellulose
Hypromellose
Talc
_Capsule Shell_
Gelatin
Yellow iron oxide (E172)
Health Products Regulatory Authority
23 October 2023
CRN00DV8Q
Page 2 of 2
Red iron oxide (E172)
Titanium dioxide (E171)
_Capsule Printing Ink_
Shellac
Red iron oxide (E172)
Ammonium Hydroxide
Simethicone
Propylene Glycol
6.2 INCOMPATIBILITIES
Not applicable.
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 Man