Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
ICHTHAMMOL
Ego Pharmaceuticals (UK) Limited
1.0 %w/w
Cream
1999-07-07
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Egoderm 1.0 %w/w Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ichthammol 1% w/w. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Cream Pale fawn coloured cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of itching and inflammation associated with the following conditions: Inflamed dermatitis or eczema; Persistent infantile eczema; Dry, cracked or fissured skin; An adjunct to the treatment of psoriasis or for maintenance therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of Administration For cutaneous (topical) use only. Recommended Dosage Schedules The cream should be applied to the affected skin area 3 times daily or as needed. 4.3 CONTRAINDICATIONS Known hypersensitivity to the ingredients of the preparation. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The cream is for external use only. Avoid contact with the eyes. Upon accidental contact, flush with clean water. If the condition does not improve or is aggravated discontinue use and consult the doctor. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No interactions known. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/07/2006_ _CRN 2025657_ _page number: 1_ 4.6 PREGNANCY AND LACTATION Use of this product in human pregnancy and lactation has not been investigated, but ichthammol has been in wide use fo many years without apparent ill consequences. No adverse effects have been reported in published literature. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Not applicable – not likely to produce an effect when used as directed. 4.8 UNDESIRABLE EFFECTS Allergic reactions to ichthammol may occur. 4.9 OVERDOS Przeczytaj cały dokument