Land: Malta
Taal: Engels
Bron: Medicines Authority
fluvoxamine maleate 100 mg
Abbott Healthcare Products Limited
N06AB08
fluvoxamine maleate
film-coated tablet
Authorised
2007-05-16
Abbott - Established Products Division Document ID: BOP.DP17.14.04.F02 Effective By Date: 15-Aug-2012 Document Type: Form Approved Date: 01-Aug-2012 Title: Mascherina TPM PLANT: PRODUCT NAME: Abbott Chatillon Faverin 50mg film-coated tablets; Faverin 100mg film-coated tablets PRESENTATION: REGULATING COUNTRY: SALES X United Kingdom; Ireland SAMPLES REQUEST REFERENCE No: LCR-00073-2013-DEV; LCR-00074-2013-DEV COMMODITY CODE: 1086931 COMMODITY TYPE: Leaflet CORE SPEC. REF : COLORS: Flat leaflet 158x600mm PHARMACODE: P. Process Black U - Cutting die X X I I X I X X I I (1835) FONT STYLE / MINIMUM FONT SIZE FOR TEXT: Helvetica Neue / 8.5 pt NOTES: Replaces 1081232 - SOLID 117244 X 06/03/2013 X 08/03/2013 Operator/Dev. D. Ratkovic Operator/Dev. D. Ratkovic Operator/Dev. Operator/Dev. Operator/Dev. Operator/Dev. Operator/Dev. Operator/Dev. Operator/Dev. Operator/Dev. LOCAL MARKET REGULATORY SIGN OFF (as appllicable for paper signature) Confirmation that this artwork has been approved. Text content and colors are correct. This component conforms with Local Market Regulatory requirements DATE: Version 2.0, Effective Control Site: EPD - Basel CH (Div QA) Page 1 of 1 This information is confidential to Abbott. The user is responsible for using the appropriate version of this document. P. Process Black U - Cutting Die FRONT 1086931_d2 L ae tu s co d e > > > L ae tu s co d e > > > 50 MG AND 100 MG FILM-COATED TABLETS fluvoxamine maleate • FAVERIN TREATS DEPRESSION AND OBSESSIVE COMPULSIVE DI Lees het volledige document
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 halves. 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 t Lees het volledige document