Fluvoxamine 100mg tablets

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktīvā sastāvdaļa:

Fluvoxamine maleate

Pieejams no:

Wockhardt UK Ltd

ATĶ kods:

N06AB08

SNN (starptautisko nepatentēto nosaukumu):

Fluvoxamine maleate

Deva:

100mg

Zāļu forma:

Oral tablet

Ievadīšanas:

Oral

Klase:

No Controlled Drug Status

Receptes veids:

Valid as a prescribable product

Produktu pārskats:

BNF: 04030300; GTIN: 5012727903699

Lietošanas instrukcija

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• Regulatory text amends
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

Produkta apraksts

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 weeks on