Fluvoxamine 100mg Film-Coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FLUVOXAMINE MALEATE

Available from:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

ATC code:

N06AB08

INN (International Name):

FLUVOXAMINE MALEATE 100 mg

Pharmaceutical form:

TABLET

Composition:

FLUVOXAMINE MALEATE 100 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Withdrawn

Authorization date:

2006-11-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUVOXAMINE 50MG FILM-COATED TABLETS
FLUVOXAMINE 100MG FILM-COATED TABLETS
Fluvoxamine maleate
(Refer to as Fluvoxamine Tablets in this leaflet)
FLUVOXAMINE TABLETS TREAT DEPRESSION AND OBSESSIVE COMPULSIVE DISORDER
(OCD). Like
all medicines it can have unwanted effects. It is therefore important
that you and your doctor
weigh up the benefits of treatment against the possible unwanted
effects, before starting
treatment.
FLUVOXAMINE TABLETS SHOULD NOT BE USED TO TREAT DEPRESSION IN CHILDREN
AND ADOLESCENTS.
See
section 2, Use in children and adolescents.
FLUVOXAMINE TABLETS WON’T WORK STRAIGHT AWAY. Some people taking
antidepressants feel
worse before feeling better. Your doctor should see you regularly
during your course of
treatment . Tell your doctor if you haven’t started feeling better.
SOME PEOPLE WHO ARE DEPRESSED OR ANXIOUS THINK OF HARMING OR KILLING
THEMSELVES. If
you start to feel worse, or think of harming or killing yourself, SEE
YOUR DOCTOR OR GO TO A
HOSPITAL STRAIGHT AWAY. SEE SECTION 2
DON’T STOP TAKING FLUVOXAMINE TABLETS WITHOUT TALKING TO YOUR
DOCTOR. If you stop taking
Fluvoxamine Tablets suddenly or miss a dose, you may get withdrawal
effects. See section 3
for further information.
IF YOU FEEL RESTLESS AND FEEL LIKE YOU CAN’T SIT OR STAND STILL,
TELL YOUR DOCTOR. Increasing the
dose of Fluvoxamine Tablets may make these feelings worse. See section
4, Possible side-
effects.
TAKING SOME OTHER MEDICINES WITH FLUVOXAMINE TABLETS CAN CAUSE
PROBLEMS. You may
need to talk to your doctor. See section 2, Taking other medicines.
IF YOU ARE PREGNANT OR PLANNING TO GET PREGNANT, talk to your doctor.
See section 2
Pregnancy and breastfeeding.
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

Summary of Product characteristics

_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluvoxamine 100mg Film-Coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluvoxamine Maleate 100mg
For a full list of excipients
,
see section 6.1
3
PHARMACEUTICAL FORM
Tablet.
White to off-white, film coated
capsule shaped
tablets. Upper face FX/100,
lower face CP.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Major depressive episode.
Obsessive Compulsive Disorder (OCD).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ Depression: _
_Adults _
The recommended dose is 100mg daily. Patients should start on 50 or
100mg,
given as a single dose in the evening. Dosage should be reviewed and
adjusted
if necessary within three to four weeks of initiation of therapy and
thereafter as
judged clinically appropriate. Although there may be an increased
potential for undesirable effects at higher doses, if after some weeks
on the
recommended dose insufficient response is seen some patients may
benefit
from having their dose increased gradually up to a maximum of 300mg a
day
(see section 5.1). Doses up to 150 mg can be given as a single dose,
preferably
in the evening. It is advisable that a total daily dose of more
than 150 mg is given in two or three divided doses. Dosage adjustments
should
be made carefully on an individual patient basis, to maintain the
patients at the
lowest effective dose.
Patients with depression should be treated for a sufficient period of
at least six
months to ensure that they are free from symptoms.
_Children/adolescents _
Fluvoxamine should not be used in children and adolescents under the
age of
18 years for the treatment of major depressive episode. The efficacy
and safety
of Fluvoxamine have not been established in the treatment of
paediatric major
depressive episode (see section 4.4).
_ _
_Obsessive Compulsive Disorder: _
_Adults _
The recommended dose is between 100-300mg daily. Patients should start
at
50mg per day. Although there may be an increased potential for
undesirable
effects at higher doses, if after some