Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
DOSULEPIN HYDROCHLORIDE
McDermott Laboratories Ltd t/a Gerard Laboratories
25 Milligram
Capsules Hard
2000-05-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dothep 25mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 25 mg of dosulepin hydrochloride. Excipients - Contains Lactose Monohydrate 94.0mg and Ponceau 4R (E124) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Brown/red hard capsule, marked ‘G DN 25’ in black ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dosulepin is indicated in the treatment of symptoms of depressive illness - in particular where an anti-anxiety effect is required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dothep capsules are administered orally. _Recommended dosage schedules:_ _Adults: _Initially 75mg/day in divided doses (as capsules) or as a single dose at night, increasing to 150mg/day. In certain circumstances e.g. in hospital use, dosages up to 225mg daily have been used. Suggested dosage regimen : 25 to 50mg three times daily or, alternatively, 75 or 150mg as a single dose at night. _Elderly: _50-75 mg daily initially. As with any antidepressant, the initial dose should be increased with caution under close supervision. Half the normal adult dose may be sufficient to produce a satisfactory clinical response. _Children: _Not recommended. 4.3 CONTRAINDICATIONS Dothep capsules are contraindicated in patients with: Closed angle glaucoma. Existing urinary retention. Recent myocardial infarction. Any degree of heart block or other cardiac arrhythmias. Mania. Severe liver disease. Women who are breast-feeding. Crrently receiving monoamine oxidase inhibitors or have received these within the previous two weeks. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 13/04/2011_ _CRN 2083154_ _p Leggi il documento completo