Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CROTAMITON
Novartis Consumer Health UK Limited
10 %w/w
Cutaneous Emulsion
1993-04-11
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eurax 10% w/w Lotion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Crotamiton 10% w/w Excipients: also includes Cetostearyl Alcohol 3.0 % w/w Sorbic Acid 0.1 % w/w Propylene Glycol 10.0 %w/w Perfume (containing benzyl benzoate) < 0.1 % w/w For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Cutaneous emulsion. White to yellowish white fluid emulsion; odour characteristic of perfume. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an antipruritic and sarcopticide for use in the management of pruritus of any aetiology and in the treatment of scabies and pediculosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Pruritus Apply to the affected area 2 to 3 times daily. Eurax will provide relief from irritation for 6-10 hours after each application. Eurax can be used in children. There are no special dosage recommendations in the elderly. Scabies After a thorough bath, Eurax should be applied to all areas below the chin with particular attention to interdigital areas. It is advisable to repeat the treatment 24 hours later. A bath should be taken a day after with a change of clothes and bedding. All contacts should be treated simultaneously in scabatic patients. Method of administration: For cutaneous use. 4.3 CONTRAINDICATIONS Use in patients hypersensitive to any of the ingredients or suffering from acute exudative dermatoses. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/09/2011_ _CRN 2103335_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If symptoms persist consult the doctor. Eurax can be used for children, although it is advised that you consult your doctor before use on infants. For externa Read the complete document