Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
REBOXETINE MESYLATE
Pharmacia Ireland
4 Milligram
Tablets
2002-04-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Edronax 4 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 4mg of reboxetine For full list of excipients, _see section 6.1._ 3 PHARMACEUTICAL FORM Tablet White, round, convex tablet with a breakline on one side. A ‘P’ is marked on the left side of the breakline. A ‘U’ is marked on the right side of the breakline. The side opposite the breakline is marked ‘7671’. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reboxetine is indicated for the acute treatment of depressive illness/major depression and for maintaining the clinical improvement in patients initially responding to treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Reboxetine is for oral use. Use in adults The recommended therapeutic dose is 4 mg twice a day (b.i.d.) i.e.8 mg/day administered orally. The full therapeutic dose can be given upon starting treatment. After 3-4 weeks, this dose can be increased to 10 mg/day in case of incomplete clinical response. The maximum daily dose should not exceed 12 mg. The minimum effective dose has not yet been established. Use in the elderly Elderly patients have been studied in clinical trials at doses of 2 mg b.i.d. However, safety and efficacy have not been evaluated in placebo-controlled conditions. Therefore, as for other antidepressants that have not been studied in placebo-controlled conditions, reboxetine cannot be recommended. Use in children and adolescents under the age of 18 years Reboxetine should not be used in the treatment of children and adolescents under the age of 18 years _(see section 4.4)._ Use in patients with renal or hepatic insufficiency The starting dose in patients with renal or hepatic Perskaitykite visą dokumentą