Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
NYSTATIN
Bristol-Myers Squibb Pharmaceuticals Ltd
100,000 %v/v
Lozenges
1984-08-14
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mycostatin Pastilles 100,000 Units 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Oral pastille containing 100,000 units Nystatin. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Pastille Yellow to light brown, circular pastilles, 15mm in diameter, with one face flat and the other slightly curved. The pastilles have an odour of aniseed and cinnamon. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The prevention and treatment of oral candidosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: No food or drink should be taken for five minutes before or one hour after consumption of the pastilles. The usual total daily dosage is 100,000 units (1 pastille) to be sucked four times daily, for 7-14 days. Children and the Elderly: No specific dosage recommendations or precautions. 4.3 CONTRAINDICATIONS Contra-indicated in patients with a history of hypersensitivity to any of the components. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE In the therapy of Candidal infections, all potential sites of infections should be treated simultaneously. This medicine contains sugar. This should be kept in mind for patients with diabetes mellitus or disaccharide intolerance. Mycostatin oral pastilles should not be used for the treatment of systemic mycoses. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 07/12/2006_ _CRN 2030864_ _page number: 1_ 4.6 PREGNANCY AND LACTATION Animal reproductive studies have not been conducted with nystatin. It is not known whether nystatin can cause foetal harm when administered to pregnant women; however absorption of nystatin Прочетете целия документ