Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
ERYTHROMYCIN
Crookes Healthcare Ltd
ERYTHROMYCIN
2 %w/w
Ointment
Withdrawn
2006-11-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aknemycin Ointment, 2 % w/w 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Erythromycin 2% w/w. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Ointment A whitish coloured ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The management of acne vulgaris particularly of the papular or pustular type. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and the Elderly: Apply sparingly to the affected area once or twice daily after thorough cleansing. Children: Not recommended. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the constituents. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Prolonged use of anti-infective may result in superinfection due to micro-organisms resistant to that anti-infective. If there is no response within 6-8 weeks alternative measures should be considered. Prolonged use is not recommended. A course should not normally exceed 6 months. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Concomitant use with other topical treatment should only be carried out with caution in view of possible cumulative local adverse effects. 4.6 PREGNANCY AND LACTATION Studies of use during pregnancy have not been conducted no statements on safety can be made. It is recommended that the preparation should only be used with caution in lactating women who are breast feeding, and on areas away from the chest. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/07/2006_ _CRN 2026147_ _page number: 1_ 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None known. 4.8 UNDESIRABLE EFFECTS Local irritation, erythema and dryness may occur. Diarrhoea has been reported rarely. 4.9 OVERDOSE Unlikely as the Læs hele dokumentet