Sudosalve Nappy Rash Treatment 0.15%w/w Cream

Cream A smooth, white cream.

4.1 Therapeutic indications Indications (a) First aid dressing for minor burns, scalds, abrasions and other open injuries and their routine treatment. (b) For the treatment of surface infections due to susceptible organisms, particularly in cases with penicillin resistant Staphylococci or certain Gramnegative bacilli. (c) Treatment of ringworm of the scalp (Microsporum canis) and other superficial fungal infections. (d) Treatment of pyodermias, including sycosis barbae. (e) Treatment of otitis externa. (f) Treatment of nappy rash.4.2 Posology and method of administration Adults: apply to the affected area, either directly or on a light dressing, two or three times a day. Elderly and children: no specific recommendations. For cutaneous use.4.3 Contraindications Sudosalve nappy rash treatment 0.15%w/w Cream should not be used in patients with known hypersensitivity to dibrompropamidine or any of the other ingredients.4.4 Special warnings and precautions for use Prolonged use may interfere with healing and cause skin necrosis in infants. This medicine contains the following excipients: • Methyl parahydroxybenzoate (E218) may cause allergic reactions (possibly delayed) • Castor oil may cause skin reactions • Cetostearyl alcohol may cause local skin reactions (eg. contact dermatitis).4.5 Interaction with other medicinal products and other forms of interaction None known4.6 Fertility, pregnancy and lactation There is no evidence of the drug's safety in human use nor is there any evidence from animal work that it is free from hazard. Avoid unless considered essential.4.7 Effects on ability to drive and use machines None.4.8 Undesirable effects There is always the possibility, although rare, of a sensitisation reaction or contact dermatitis occurring: in such an event, treatment should be discontinued immediately. **Reporting of suspected adverse reactions** Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose The 25g tube of Sudosalve nappy rash treatment 0.15%w/w Cream contains 37.5mg of dibrompropamidine, the 30g contains 45mg and the 50g contains 75mg. No toxic effects are likely to occur even if the contents of a full tube are accidentally ingested. Similarly, the ingredients of the base are unlikely to have toxic effects in the quantities present.

5.1 Pharmacodynamic properties ATC code: D08AC01 Dibrompropamidine isetionate is an antibacterial agent active against pathogenic Streptococci and Staphylococci, including penicillin resistant strains, and has some activity against a number of Gram negative bacilli. Its antibacterial action is not inhibited by pus, blood or p-aminabenzoic acid. In addition, it has useful activity against certain species of pathogenic fungi. Sudosalve nappy rash treatment 0.15%w/w Cream is well tolerated and rarely gives rise to sensitisation reactions or contact dermatitis.5.2 Pharmacokinetic properties No data available.5.3 Preclinical safety data No relevant data.

6.1 List of excipients Castor oil, virgin Cetostearyl alcohol Polyethylene glycol 600 monostearate Methyl parahydroxybenzoate Silicone MS Antifoam A Purified water6.2 Incompatibilities Not applicable.6.3 Shelf life 36 months6.4 Special precautions for storage Store below 25°C.6.5 Nature and contents of container Collapsible aluminium internally lacquered tube with extended nozzle containing 25g, 30g or 50g cream. Polythene plug seal cap.6.6 Special precautions for disposal and other handling Not applicable.