Riik: Armeenia
keel: inglise
Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
fluvoxamine (fluvoxamine maleate)
Abbott Healthcare SAS
fluvoxamine (fluvoxamine maleate)
100mg
tablets film-coated
Prescription
SUMMARY OF PRODUCT CHARACTERISTIC (SMPC) FLUVOXAMINE 1 NAME OF THE MEDICINAL PRODUCT Fevarin®, film-coated tablets, 50 mg Fevarin®, film-coated tablets, 100 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: fluvoxamine maleate Each tablet contains 50 mg or 100 mg of fluvoxamine maleate. For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets 50mg Round, biconvex, scored, white to off-white film coated tablets for oral administration. The tablets can be divided into equal halves. Film-coated tablets 100mg Oval, biconvex, scored, white to off-white film coated tablets for oral administration. The tablets 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 The recommended starting dose is 50 or 100 mg, given as a single dose in the evening. It is recommended to increase the dose gradually until an effective dose is reached. The usual effective dose is 100 mg per day and should be adjusted on individual patient response. Doses of up to 300 mg per day have been given. Dosages above 150 mg should be given in divided doses. In agreement with the consensus statement of the WHO, antidepressant medication should be continued for at least 6 months after recovery from a depressive episode. Fluvoxamine at a fixed single daily dose of 100 mg is the recommended dose for the prevention of recurrence of depression. Obsessive compulsive disorder SUMMARY OF PRODUCT CHARACTERISTIC (SMPC) FLUVOXAMINE _Adults_ The recommended starting dose is 50 mg per day for 3 - 4 days. The effective dosage usually lies between 100 mg and 300 mg per day. The dosage should be increased gradually until the effective dosage is achieved, with a maximum of 300 mg per day. 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. If a good Lugege kogu dokumenti