APO-FLUVOXAMINE fluvoxamine maleate 100 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluvoxamine maleate, Quantity: 100 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Fluvoxamine maleate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: titanium dioxide; mannitol; macrogol 8000; magnesium stearate; hyetellose; iron oxide red; iron oxide yellow; iron oxide black

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Indicated for the treatment of major depression in adults. Indicated for the treatment of Obsessive Compulsive Disorder in children aged 8 years of age and older, adolescents, and adults.

Product summary:

Visual Identification: Reddish-brown, pillow-shaped scored tablet, film coated, engraved "APO" on one side, and "FLU bisect 100" on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2009-01-14

Patient Information leaflet

APO-FLUVOXAMINE
1
APO-FLUVOXAMINE
_Fluvoxamine maleate _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about fluvoxamine. It does
not contain all 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 using 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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Fluvoxamine is used to treat
depression in adults, as well as
obsessive compulsive disorder
(OCD) in adults and children aged
eight years old and above.
Fluvoxamine belongs to a group of
medicines known as selective
serotonin reuptake inhibitors
(SSRIs).
It works to correct the chemical
imbalance in the brain that are
thought to cause depression and
OCD, helping to relieve symptoms.
DEPRESSION
Depression can cause emotional and
physical symptoms such as loss of
interest in activities, disturbed sleep
and lack of energy.
OCD
Patients with OCD can have two
types of symptoms – obsessions
(unwanted repeated thoughts or
feelings) and compulsions (the need
to repeat actions over and over).
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
There is not enough information to
recommend the use of this medicine
for treating depression in children
aged under 18 years, or for treating
OCD in children under eight years of
age.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
fluvoxamine
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-FLUVOXAMINE (FLUVOXAMINE MALEATE) FILM
COATED TABLETS
1
NAME OF THE MEDICINE
Fluvoxamine Maleate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg or 100 mg fluvoxamine maleate.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APO-FLUVOXAMINE TABLETS 50 MG
Golden, round, scored, film-coated tablets engraved APO on one side,
“F” over bisect “50” on
the other side.
APO-FLUVOXAMINE TABLETS 100 MG
Reddish-brown, pillow shaped, scored, film-coated tablet engraved APO
on one side, FLU
bisect 100 on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
the treatment of major depression in adults.
-
the treatment of Obsessive Compulsive Disorder (OCD) in children aged
8 years of age
and older, adolescents, and adults.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-FLUVOXAMINE TABLETS are intended for oral 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
usually 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 of the WHO, antidepressant
medication should be
continued for at least 6 months after recovery from a depressive
episode.
2
OBSESSIVE COMPULSIVE DISORDER
Adults:
The recommended starting dose of fluvoxamine is 50 mg per day for 3 to
4 days. The dosage
should be increased gradually (i.e. by 50 mg every 4 to 6 days) until
an effective dose is
achieved, with a maximum of 300 mg per day.