Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ANTAZOLINE HYDROCHLORIDE CALAMINE CETRIMONIUM BROMIDE
Co-Pharma Limited
1.8/8/0.5 %w/w
Cream
1996-08-11
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT RBC Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 25 g of paste contains 1.8% w/w of Antazoline hydrochloride, 8% of Calamine, 0.5% of Cetrimide. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Cream A pale pink paste. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of allergic skin disorders such as pruritus, urticaria, insect bites and stings, nettle rash, hives, for the relief of itching accompanying chicken pox and shingles, for the relief of sunburn and prickly heat. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For external use only. Apply sparingly 3 to 4 times daily for up to 3 days or as directed by the physician. 4.3 CONTRAINDICATIONS Eczema, open wounds, symptoms persisting for more than 2-3 days. Sensitivity to any constituent. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If symptoms persist after 2-3 days, consult a doctor. Discontinue in case of skin sensitivity. Do not apply to open wounds or eczema. For external use only. Keep all medicines away from children. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6 PREGNANCY AND LACTATION No adverse effects known. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 31/07/2006_ _CRN 2026222_ _page number: 1_ 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES No or negligible effect. 4.8 UNDESIRABLE EFFECTS Rare cases of sensitivity have been reported, which subside on application being discontinued. 4.9 OVERDOSE Not applicable; for external use only. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Antazoline is a weak antihistamine with local anaesthetic properties. Cetrimide is an antiseptic. Ca Read the complete document