Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
MIRTAZAPINE
Ergha Healthcare Ltd
15 Milligram
Orodispersible Tablet
2009-08-14
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bexmirt 15mg Ordispersible Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 15mg of mirtazapine. Excipients: includes 6 mg aspartame (E951) per tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet Round biconvex, white or almost white, uncoated tablets marked ‘M1’ 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 45mg; 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: Bexmirt should not be used in children and adolescents under the age of 18 years. (see section 4.4). Renal impairment The clearance of mirtazapine may be decreased in patients with moderate to severe renal impairment (creatinine clearance <40 ml/min). This should be taken into account when prescribing Bexmirt to this category of patients (see section 4.4). Hepatic impairment The clearance of mirtazapine may be decreased in patients with hepatic impairment. This should be taken into account when prescribing Bexmirt to this category of patients, particularly with severe Belgenin tamamını okuyun