Efexor XL 75mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Venlafaxine hydrochloride

Available from:

DE Pharmaceuticals

ATC code:

N06AX16

INN (International Name):

Venlafaxine hydrochloride

Dosage:

75mg

Pharmaceutical form:

Modified-release capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030400

Patient Information leaflet

Helvetica Neue LT W1G
8.5 pt
8.5 pt
EFEXOR_XL_75mg_150mg_225mg_28_PP EFEXOR XL
75/150/225mg GB
Leaflet
3060267
PAA195745
3060267
PL 50622/0020
Pfizer Manufacturing
Freiburg (Freiburg - DE)
003000009450_3_594x180mm_
v1_FVID1326650
PAA205453
2489
400567497;400567568;
400567496
108355609/0106
2
United Kingdom
N/A
1
180 x 594 mm
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V2 Oct 2022
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19 Mar 23
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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
bef

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Efexor XL 75 mg prolonged-release capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
Opaque peach capsules printed in red with ‘W’ and ‘75’ hard
gelatin capsule, size 1
(19.4 mm x 6.91 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-release venla