Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ECONAZOLE NITRATE
Bristol-Myers Squibb Pharmaceuticals Ltd
1 %w/w
Cream
1978-01-30
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ecostatin Cream 1% w/w 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Econazole nitrate 1.0% w/w. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Cream. A smooth white to off-white aqueous cream, with a distinctly perfumed odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the topical treatment of fungal or yeast infections and certain skin infections caused by streptococci or staphylococci. These include ringworm (Tinea) infections, athlete’s foot, paronychia, pityriasis versicolor, erythrasma, intertrigo, fungal nappy rash, candidal vulvitis and candidal balanitis. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Adults and Children: To be massaged gently into the affected and surrounding skin area morning and evening. It is particularly suitable for moist or weeping lesions. Infants and neonates: No special dosage recommendations. Elderly: No specific dosage recommendations or precautions apply. 4.3 CONTRAINDICATIONS Patients with a history of sensitivity to any of the components of the preparation. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This preparation is not for oral use. It should not be used in or near the eyes. When Ecostatin Cream is being used on the anogenital area, it is important to ensure the concurrent treatment of partners. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/06/2006_ _CRN 2024312_ _page number: 1_ 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None. 4.6 PREGNANCY AND LACTATION There is no evidence of a teratogenic effect in animals. Systemic absorption is likely to be negligible. However, as with other agents, use should be avoided during the first trimester o Read the complete document