Venlafaxine Fair-Med 150mg prolonged-release capsules, hard

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

VENLAFAXINE

Tilgængelig fra:

FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany

ATC-kode:

N06AX16

INN (International Name):

VENLAFAXINE 150 mg

Lægemiddelform:

PROLONGED-RELEASE HARD CAPSULE

Sammensætning:

VENLAFAXINE 150 mg

Recept type:

POM

Terapeutisk område:

PSYCHOANALEPTICS

Autorisation status:

Withdrawn

Autorisation dato:

2012-02-17

Indlægsseddel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VENLAFAXINE FAIR-MED 37.5 MG PROLONGED-RELEASE CAPSULES, HARD
VENLAFAXINE FAIR-MED 75 MG PROLONGED-RELEASE CAPSULES, HARD
VENLAFAXINE FAIR-MED 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 Venlafaxine Fair-Med is and what it is used for
2.
What you need to know before
you take Venlafaxine Fair-Med
3.
How to take Venlafaxine Fair-Med
4.
Possible side effects
5.
How to store Venlafaxine Fair-Med
6.
Contents of the pack and other information
1. WHAT VENLAFAXINE FAIR-MED IS AND WHAT IT IS USED FOR
Venlafaxine Fair-Med 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.
Venlafaxine Fair-Med is a treatment for adults with depression.
Venlafaxine Fair-Med 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

Produktets egenskaber

1
1. NAME OF THE MEDICINAL PRODUCT
Venlafaxine Fair-Med 37.5mg prolonged-release capsules, hard
Venlafaxine Fair-Med 75mg prolonged-release capsules, hard
Venlafaxine Fair-Med 150mg prolonged-release capsules, hard
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Venlafaxine Fair-Med 37.5mg capsules contain venlafaxine
hydrochloride, equivalent to
37.5mg of venlafaxine.
Venlafaxine Fair-Med 75mg capsules contain venlafaxine hydrochloride,
equivalent to 75mg
of venlafaxine.
Venlafaxine Fair-Med 150mg capsules contain venlafaxine hydrochloride,
equivalent to
150mg of venlafaxine.
Excipients with known effect:
Each 150 mg prolonged-release capsule, hard, contains 39.686 mg of
E110 sunset yellow FCF
Each 150 mg prolonged-release capsule, hard, contains 19.872 mg of
E129 allura red AC
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Hard prolonged-release capsule
Venlafaxine Fair-Med 37.5mg: light grey opaque / peach opaque, size
“3” hard gelatin
capsules having thick and thin radial circular band on the body in red
ink and thick and thin
radial circular band on the cap in red ink. The capsule is filled with
3 white to off-white,
round biconvex, film-coated mini tablets of 12.5mg each.
Venlafaxine Fair-Med 75mg: peach opaque / peach opaque, size “1”
hard gelatin capsules
having thick and thin radial circular band on the body in red ink and
thick and thin radial
circular band on the cap in red ink. The capsule is filled with 6
white to off-white, round
biconvex, film-coated mini tablets of 12.5mg each.
Venlafaxine Fair-Med 150mg: dark orange / dark orange opaque, size
“0” hard gelatin
capsules having thick and thin radial circular band on the body in
white ink and thick and thin
radial circular band on the cap in white ink. The capsule is filled
with 12 white to off-white,
round biconvex, film-coated mini tablets of 12.5mg each.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
For prevention of recurrence of major depressive episodes.
Treatment o