Efexor XL 75 mg prolonged-release capsules, hard

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Venlafaxine

Beszerezhető a:

IMED Healthcare Ltd.

ATC-kód:

N06AX; N06AX16

INN (nemzetközi neve):

Venlafaxine

Gyógyszerészeti forma:

Prolonged-release capsule, hard

Terápiás terület:

Other antidepressants; venlafaxine

Engedély dátuma:

2023-08-14

Betegtájékoztató

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 have taken

Termékjellemzők

Health Products Regulatory Authority
15 August 2023
CRN00DKTV
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 Greece:_
Opaque peach capsules printed in red with 'W' and '75' hard gelatin
capsule.
4 CLINICAL PARTICULARS
As per PA23355/002/002
5 PHARMACOLOGICAL PROPERTIES
As per PA23355/002/002
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.
6.3 SHELF LIFE
Health Products Regulatory Authority
15 August 2023
CRN00DKTV
Page 2 of 2
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
o
C.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs containing 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
PPA1463/209/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 14
th
August 2023
10 DATE OF REVISION OF THE TEXT