Efexor XL 150mg capsules

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Venlafaxine hydrochloride

Tilgjengelig fra:

Mawdsley-Brooks & Company Ltd

ATC-kode:

N06AX16

INN (International Name):

Venlafaxine hydrochloride

Dosering :

150mg

Legemiddelform:

Modified-release capsule

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 04030400

Informasjon til brukeren

mockup 6104
Druckreif:
Package Leaflet: Information for the user
Efexor XL 75 mg prolonged-release capsules, hard
Efexor XL 150 mg prolonged-release capsules, hard
Efexor XL 225 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 Efexo

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Efexor XL 150 mg prolonged-release capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
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.
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 also be appropriate for prevention of recurrence of
major
depressive episodes (MDE). In most of the cases, the recommended dose
in
prevention of recurrence of MDE is the same as the one used during the
current
episode.
_ _
Antidepressive medicinal products should continue for at least six
months following
remission.
GENERALISED ANXIETY DISORDER
The recommended starting dose for prolonged-r