Ülke: İsrail
Dil: İngilizce
Kaynak: Ministry of Health
REBOXETINE METHAN SULFONATE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
N06AX18
TABLETS
REBOXETINE METHAN SULFONATE 4 MG
PER OS
Required
PFIZER ITALIA S.R.L, ITALY
REBOXETINE
REBOXETINE
Reboxetine is indicated for the acute treatment of depressive illness/major depression and for maintaining the clinical improvement in patients initially responding to treatment.
2014-04-30
Edromax LPD CC 160124 2021-0069012 , 2022-0080734 Page: 1 of 9 EDRONAX ® 1. NAME OF THE MEDICINAL PRODUCT Edronax 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 4 mg of reboxetine For the 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. The onset of the clinical effect is generally seen after 14 days from treatment start. 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/day. The minimum effective dose has not yet been established. 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. Paediatric population Reboxetine should not be used in the treatment of children and adolescents under the age of 18 years (see section 4.4). Renal or hepatic impairment The starting dose in patients with renal or hepaticimpairment should be 2 mg b.i.d which can be increased based on patient tolerance. Method of administration Reboxetine is for oral use. 4.3. Contraindications Edromax LPD CC 160124 2021-0069012 , 2022-0080734 Belgenin tamamını okuyun