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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
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