Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GLYCOL MONOSALICYLATE METHYL NICOTINATE CAPSAICIN
SSL International plc
10/1/0.12% %v/v
Cream
2006-07-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ralgex Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ralgex Cream contains: Excipients: Contains Methylhydroxybenzoate (E218) 0.20 %w/w Butylhydroxybenzoate (E216) 0.10 % w/w Emulsifying wax 9.0 % w/w (contains cetostearyl alcohol) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream Thick, off-white, homogeneous cream with a characteristic odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic relief of muscular pain and stiffness, including backache, sciatica, lumbago, fibrositis and rheumatic pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children aged 12 years and over After trial use, rub into the skin until absorbed. To be applied as required to the affected area. Repeat as necessary up to four times a day. Not to be used on children under 12 years except on medical advice. The elderly The normal adult directions for use can be followed. 4.3 CONTRAINDICATIONS Known hypersensitivity to salicylates or to any of the ingredients of the cream. Injuries involving broken skin. Glycol Monosalicylate 10.0 % w/w Methyl Nicotinate 1.0 % w/w Capsicum Oleoresin 0.12 % w/w IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 31/08/2011_ _CRN 2104570_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Side effects include local irritation and occasionally allergic reactions. Do not apply near the eyes, mouth or on sensitive body areas. If symptoms persist or the condition is aggravated, consult the doctor. Day-to-day variation may occur in the sensitivity of the skin, which is more sensitive after a hot bath or in hot weather. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORM Read the complete document