MIRTAZIPINE GLOB
Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Produktets egenskaber
(SPC)
15-06-2024
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Aktiv bestanddel:
MIRTAZAPINE
Tilgængelig fra:
Glob Limited
Dosering:
30 Milligram
Lægemiddelform:
Film Coated Tablet
Autorisation dato:
2011-09-30
Produktets egenskaber
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mirtazapine Glob 30 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 30 mg film coated tablet contains mirtazapine 30 mg.
Each Mirtazapine Glob 30 mg film-coated tablet contains 204 mg lactose (as monohydrate).
For a full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Film coated tablet
Mirtazapine 30 mg tablets are Reddish Brown, biconvex, capsule shaped, film coated tablets with a score line in
between 0 and 9 debossed on one side and ‘A’ on the other side.
The tablet can be divided into equal halves.
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
Mirtazapine 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
cleara
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