SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Mycota Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Zinc Undecylenate Ph. Eur. 20.0% w/w Undecylenic Acid Ph. Eur. 5.0% w/w For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Cream for topical administration

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the treatment and prevention of athlete’s foot

4.2 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.

Contraindications

Hypersensitivity to any of the ingredients

4.4    Special warnings and precautions for use

The label states for external use only, keep all medicines out of the reach and sight 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.

4.5    Interactions with other medicinal products and other forms of interaction

No clinically significant drug interactions known

4.6    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 known

4.8    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.

PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Undecylenic Acid and Zinc Undecylenate have antifungal and antibacterial properties.

5.2    Pharmacokinetic properties

None stated

5.3    Preclinical safety data

Not applicable

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients Liquid Paraffin Ph. Eur.

Emulsifying Wax BP

Perfume Compound 11899 NAROM HSE

Purified Water Ph. Eur.

6.2    Incompatibilities

Not applicable

6.3    Shelf life

36 months

6.4    Special precautions for storage

None

6.5    Nature and contents of container

Collapsible aluminium internally lacquered tube containing 25g of cream, fitted with a polypropylene plug seal

6.6    Special precautions for disposal

Not applicable

7    MARKETING AUTHORISATION HOLDER

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

8    MARKETING AUTHORISATION NUMBER(S)

PL 00240/0064

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

13/08/2003

10 DATE OF REVISION OF THE TEXT

26/11/2014