FAVOXIL 100

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

FLUVOXAMINE MALEATE

可用日期:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ATC代码:

N06AB08

药物剂型:

TABLETS

组成:

FLUVOXAMINE MALEATE 100 MG

给药途径:

PER OS

处方类型:

Required

厂商:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

治疗组:

FLUVOXAMINE

治疗领域:

FLUVOXAMINE

疗效迹象:

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).

授权日期:

2014-06-30

产品特点

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