Mycota Cream

Cream for topical administration

4.1 Therapeutic indications For the treatment and prevention of athlete's foot4.2 Posology and method of administration **Adults, Children and Elderly** **Treatment** Each night and morning wash thoroughly dry the foot, then smooth the cream on to the affected area. Take particular care to ensure the cream is massaged between the toes then dust with Mycota Powder. Wear clean socks or stockings each day dusted inside with Mycota Powder. Continue this treatment for one week after all signs of infection have disappeared. **Prevention** Each day rub in Mycota Cream and dust socks or stockings inside with Mycota Powder.4.3 Contraindications Hypersensitivity to any of the ingredients4.4 Special warnings and precautions for use The label states for external use only, keep all medicines out of the sight and reach of children. Contact with the eyes and mucous membranes should be avoided. Treatment should be discontinued if irritation is severe. Do not apply to broken skin. **Excipient warnings**: This medicine contains Emulsifying wax with 1.4% w/w Sodium laurilsulfate. Sodium laurilsulfate may cause local skin reactions (such as stinging or burning sensation) or increase skin reactions caused by other products when applied on the same area. This medicine contains Emulsifying wax with 1.36% w/w Cetostearyl alcohol. Cetosteryl alcohol may cause local skin reactions (e.g. contact dermatitis). This medicine contains fragrance with Euganol, which may cause an allergic reaction.4.5 Interaction with other medicinal products and other forms of interaction No clinically significant drug interactions known4.6 Fertility, pregnancy and lactation Although there is no specific data available concerning the use of Mycota Cream during pregnancy and lactation, it is not considered to constitute a hazard.4.7 Effects on ability to drive and use machines No adverse effects known4.8 Undesirable effects Hypersensitivity reactions may occasionally occur. Irritation of the skin may rarely occur. **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.4.9 Overdose Excessive application to the skin is unlikely to cause untoward effects. In the unlikely event of ingestion of Mycota Cream symptoms of overdosage may include nausea, vomiting, diarrhoea and general gastrointestinal disturbances. Treatment need only be symptomatic.

5.1 Pharmacodynamic properties Undecylenic Acid and Zinc Undecylenate have antifungal and antibacterial properties.5.2 Pharmacokinetic properties None stated5.3 Preclinical safety data Not applicable

6.1 List of excipients Liquid Paraffin Ph. Eur. Emulsifying Wax BP (Contains Cetostearyl alcohol and Sodium laurilsulfate) Perfume Compound 11899 NAROM HSE (Contains Euganol) Purified Water Ph. Eur.6.2 Incompatibilities Not applicable6.3 Shelf life 36 months6.4 Special precautions for storage None6.5 Nature and contents of container Collapsible aluminium internally lacquered tube containing 25g of cream, fitted with a polypropylene plug seal6.6 Special precautions for disposal and other handling Not applicable