Land: Armenia
Språk: engelsk
Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
fluvoxamine (fluvoxamine maleate)
Mylan Laboratories SAS
N06AB08
fluvoxamine (fluvoxamine maleate)
100mg
tablets film-coated
(15/1x15/) in blister
Prescription
Registered
2019-04-22
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 _Adults _ The recommended dose is 100 mg. Treatment begins with a dose of 50 mg or 100 mg (once, in the evening). If necessary, the dosage regimen should be reviewed and adjusted during the first 3 to 4 weeks of treatment and during further treatment if this is clinically justified. Since there is an increased risk of undesirable effects when taking high doses of the drug, as well as in the case of insufficient action after several weeks of use, some patients are shown to gradually increase the dose to the maximum daily value of 300 mg (see the section 5.1). A single dose of 150 mg (the maximum single dose) can be prescribed, which is preferably taken in the evening. If the daily dose exceeds 150 mg, it is recommended to divide it into 2 or 3 doses. The selection of the effective dose should be carried out with care on an individual basis and set in such a way as to constitute the minimum effective dose for the patient. The treatment period for patients suffering from depression should be sufficient to ensure that symptoms disappear (at least 6 months). _Children and adolescents_ Fluvoxamine is not recommended for use in children and adolescents under 18 y Les hele dokumentet