Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
MIRTAZAPINE
Organon (Ireland) Limited
15 Milligram
Orodispersible Tablet
2003-02-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zispin Sol Tab 15 mg, orodispersible tablet. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Zispin SolTab 15 mg orodispersible tablet contains 15mg of mirtazapine. Excipients: Each Zispin SolTab 15 mg orodispersible tablet contains 4.65 mg aspartame and 28 mg sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet. 15 mg orodispersible tablet: Round, white, standard bevelled-edge, coded with ‘TZ/1’ on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of episodes of major depression. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults The effective daily dose is usually between 15 and 45 mg; the starting dose is 15 or 30mg. Mirtazapine begins to exert its effect in general after 1-2 weeks of treatment. Treatment with an adequate dose should result in a positive response within 2-4 weeks. With an insufficient response, the dose can be increased up to the maximum dose. If there is no response within a further 2-4 weeks, then treatment should be stopped. Elderly The recommended dose is the same as that for adults. In elderly patients an increase in dosing should be done under close supervision to elicit a satisfactory and safe response. Children and adolescents under the age of 18 years Zispin should not be used in children and adolescents under the age of 18 years as efficacy was not demonstrated in two short-term clinical trials (see section 5.1) and because of safety concerns (see sections 4.4, 4.8 and 5.1). Renal impairment The clearance of mirtazapine may be decreased in patients with moderate to severe renal impairment (creatinine clearance <40 ml/min). (creatinine clearance <40 ml/min). This should be taken into account when presc Read the complete document