FAVOXIL 100

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FLUVOXAMINE MALEATE

Available from:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ATC code:

N06AB08

Pharmaceutical form:

TABLETS

Composition:

FLUVOXAMINE MALEATE 100 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

Therapeutic group:

FLUVOXAMINE

Therapeutic area:

FLUVOXAMINE

Therapeutic indications:

For the treatment of affective disorders characterized by persistent low mood, impaired psychomotor atctivities and psychomatic complaints including symptoms of depression. Treatment of obsessive compulsive disorders (OCD).

Authorization date:

2014-06-30

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Favoxil
50/ Favoxil 100
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
3.
PHARMACEUTICAL FORM
Tablets
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior
in children,
adolescents, and young adults in short-term studies. These studies did
not show an
increase in the risk of suicidal thoughts and behavior with
antidepressant use in
patients over age 25; there was a reduction in risk with
antidepressant use in patients
aged 65 and older [see Warnings and Precautions (4.4)].
In patients of all ages who are started on antidepressant therapy
monitor closely for
clinical worsening and emergence of suicidal thoughts and behaviors.
Advise families
and caregivers of the need for close observation and communication
with the
prescriber [see Warnings and Precautions (4.4)].
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
For the treatment of affective disorders characterized by persistent
low mood,
impaired psychomotor activities and psychomatic complaints including
symptoms of
depression.
Treatment of obsessive compulsive disorders (OCD).
4.2
Posology and method of administration
_Depression _
_Adults _
The recommended dose is 100 mg daily. Patients should start on 50 or
100 mg,
given as a single dose in the evening. Dosage should be reviewed and
adjusted if
necessary within 3 to 4 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 300 mg 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 2 or 3 divided