Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
MIRTAZAPINE
Niche Generics Limited
MIRTAZAPINE
45 Milligram
Orodispersible Tablet
Product subject to prescription which may not be renewed (A)
Withdrawn
2012-03-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mirzaten 45 mg orodispersible tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 45mg mirtazapine. Excipients: One orodispersible tablet contains 106.87 mg lactose, 14.8 - 41.5 mg sorbitol and 4.8 mg aspartame. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible Tablet White, round, biconvex, orodispersible tablets. 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 30 mg. 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 Mirzaten 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 renalimpairment (creatinine clearance <40 ml/min). This should be taken into account when prescribing Mirzaten 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 Mirzaten to this category of Read the complete document