Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
FLUVOXAMINE MALEATE
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
N06AB08
TABLETS
FLUVOXAMINE MALEATE 100 MG
PER OS
Required
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
FLUVOXAMINE
FLUVOXAMINE
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).
2014-06-30
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 Olvassa el a teljes dokumentumot