Efexor XL 150mg Prolonged-release capsules, hard

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

VENLAFAXINE

Tilgjengelig fra:

Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece

ATC-kode:

N06AX16

INN (International Name):

VENLAFAXINE 150 mg

Legemiddelform:

PROLONGED-RELEASE CAPSULE

Sammensetning:

VENLAFAXINE 150 mg

Resept typen:

POM

Terapeutisk område:

PSYCHOANALEPTICS

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2006-08-17

Informasjon til brukeren

Page 1 of 12
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 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 away and may become
more serious and more difficult to treat.
Page 2 of 12
2. WHAT YOU NEED TO KNOW BEF

Preparatomtale

Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Efexor XL 75 mg prolonged-release capsules, hard
Efexor XL 150 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.
Efexor XL 150 mg:
Each prolonged-release capsule contains 169.7 mg of venlafaxine
hydrochloride, equivalent to 150 mg
of venlafaxine free base.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release capsule, hard.
Efexor XL 75 mg:
Opaque peach capsules printed in red with ‘W’ and ‘75’ hard
gelatin capsule, size 1 (19.4 mm x
6.91 mm).
Efexor XL 150 mg:
Opaque dark orange capsules printed in white with ‘W’ and
‘150’, hard gelatin capsule, size 0
(23.5 mm x 7.65 mm).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
For prevention of recurrence of major depressive episodes.
Treatment of generalised anxiety disorder.
Treatment of social anxiety disorder.
_ _
Treatment of panic disorder, with or without agoraphobia.
Page 2 of 22
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Major depressive episodes
The recommended starting dose for prolonged-release venlafaxine is 75
mg given once daily. Patients
not responding to the initial 75 mg/day dose may benefit from dose
increases up to a maximum dose of
375 mg/day. Dosage increases can be made at intervals of 2 weeks or
more. If clinically warranted due
to symptom severity, dose increases can be made at more frequent
intervals, but not less than 4 days.
Because of the risk of dose-related adverse effects, dose increments
should be made only after a
clinical evaluation (see section 4.4). The lowest effective dose
should be maintained.
Patients should be treated for a sufficient period of time, usually
several months or longer. Treatment
should be reassessed regularly on a case-by-case basis. Longer-term
treatment may al