البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
FLUVOXAMINE MALEATE
BGP Products Ltd
N06AB08
FLUVOXAMINE MALEATE
100 Milligram
Film Coated Tablet
Oral use
Packs sizes: 15, 20, 30, 50, 60, 90, 100, 120 or 250 tablets
Product subject to prescription which may not be renewed (A)
BGP Products Ltd
Antidepressants, Selective serotonin reuptake inhibitors
Selective serotonin reuptake inhibitors
It is indicated for Depression and Obsessive Compulsive Disorder
Authorised
2015-03-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Faverin 100 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg fluvoxamine maleate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Oval, biconvex, scored, white to off-white film-coated tablets imprinted '313' on both sides of the score The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Major depressive episode - Obsessive Compulsive Disorder (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 doses. Dosage adjustments should be made carefully on an individual patient basis, to maintain the patients at the lowest effective dose. Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms. _Children/adolescents_ Faverin should not be used in children and adolescents under the age of 18 years for the treatment of major depressive episode. The efficacy and safety of Faverin have not be اقرأ الوثيقة كاملة