VOXAM fluvoxamine maleate 50mg tablet blister pack

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

fluvoxamine maleate

Prieinama:

Sandoz Pty Ltd

INN (Tarptautinis Pavadinimas):

Fluvoxamine maleate

Autorizacija statusas:

Registered

Pakuotės lapelis

VOXAM
®
1
VOXAM
®
_fluvoxamine maleate tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Voxam.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST. KEEP THIS
LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT VOXAM IS
USED FOR
Voxam contains fluvoxamine. It
belongs to a family of medicines
known as selective serotonin
reuptake inhibitors (SSRIs) and is
used for treatment of the conditions
listed below, or your doctor may
prescribe Voxam for another reason.
DEPRESSION
This medicine is used to treat
depression in adults only. It is not
recommended for treatment of this
condition in children and adolescents
as the safety and effectiveness of this
medicine, when used for depression
in this age group, have not been
established.
Depression is longer lasting and/or
more severe than the "low moods"
everyone has from time to time due
to the stress of everyday life. It can
affect your whole body and can cause
emotional and physical symptoms
such as feeling low in spirit, loss of
interest in activities, being unable to
enjoy life, poor appetite or
overeating, disturbed sleep, often
waking up early, loss of sex drive,
lack of energy and feeling guilty for
no reason.
OBSESSIVE COMPULSIVE DISORDER
(OCD)
Voxam is also used to treat a
condition known as obsessive
compulsive disorder (OCD) in adults
and children eight years of age or
older.
People with OCD can have two types
of symptoms - obsessions and
compulsions. Obsessions are
unwanted repeated thoughts or
feelings, which are ongoing.
Compulsions are the need to repeat
actions over and over. The symptoms
of OCD can vary from patient to
patient.
Both of these conditions are thought
to be caused by

Prekės savybės

200520-Voxam-pi
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION
VOXAM (FLUVOXAMINE MALEATE) TABLETS
1.
NAME OF THE MEDICINE
Fluvoxamine maleate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluvoxamine is a member of a class of antidepressant agents known as
selective serotonin
reuptake inhibitors (SSRI). It is chemically unrelated to the
tricyclic antidepressants, and to
other serotonin reuptake inhibitors as it is a monocyclic compound.
Each 50 mg Voxam tablets contain 50 mg fluvoxamine maleate.
Each 100 mg Voxam tablets contain 100 mg fluvoxamine maleate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Voxam (fluvoxamine maleate) 50 mg tablets - round, biconvex, white,
scored film-coated
tablets inscribed with ‘291’ on one side, on either side of the
score.
Voxam (fluvoxamine maleate) 100 mg tablets - oval, biconvex, white,
scored film-coated tablet,
inscribed ‘313’ on one side, on either side of the score.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Voxam (fluvoxamine maleate) is indicated for the treatment of major
depression in adults.
Voxam (fluvoxamine maleate) is also indicated for the treatment of
Obsessive Compulsive
Disorder (OCD) in children aged 8 years of age and older, adolescents,
and adults.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_DEPRESSION _
The recommended starting dose of fluvoxamine is 50 mg per day for one
week, given as a
single dose in the evening. Doses should be gradually increased (by 50
mg per week) until an
effective dose is reached, with a maximum of 300 mg per day. (the
usual effective dose is 100
mg/day). Doses up to 150 mg can be given as a single dose. It is
recommended that total daily
doses of greater than 150 mg be given in 2 or 3 divided doses.
If no improvement is observed within 6 weeks of initiation of therapy,
treatment with
fluvoxamine should be reconsidered. It is important to ascertain that
an adequate therapeutic
dose has been maintained throughout this period.
In agreement with the consensus statement