SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Mycota Powder

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Quantity/dose unit or % quantity

Zinc Undecylenate Ph.Eur 20.00 %w/w Undecylenic Acid Ph.Eur 2.00 %w/w

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Cutaneous powder.

A cream coloured powder free from lumps; perfumed.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the treatment and prevention of athlete's foot.

4.2 Posology and method of administration

Route of administration: Cutaneous

Treatment

Each night and morning wash and thoroughly dry the affected parts and sprinkle on Mycota Powder (preferably after applying Mycota Cream or Spray to the area). Ensure a generous application between the toes and each day wear clean socks or stockings dusted inside with Mycota Powder. Continue treatment for one week after all evidence of infection has disappeared.

Prevention

Sprinkle Mycota Powder inside socks or stockings daily.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

For external use only.

Contact wit the eyes and mucous membranes should be avoided.

Do not apply to broken skin.

Treatment should be discontinued if irritation is severe.

Keep all medicines out of the reach of children.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant interactions known.

4.6 Pregnancy and lactation

The safety of Mycota Powder during pregnancy and lactation has not been established but use during these periods is not considered to constitute a hazard.

4.7 Effects on ability to drive and use machines

No or negligible influence.

4.8 Undesirable effects

Hypersensitivity reactions may occur occasionally. 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 Powder symptoms of overdose may include nausea, vomiting and general intestinal disturbances.

Treatment

Symptomatic.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

D01A E - Other antifungals for topical use

Undecylenic Acid and Zinc Undecylenate have anti-fungal and anti-bacterial properties.

Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6.1 List of excipients

Maize Starch Light Kaolin Perfume

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

36 months unopened.

6.4 Special precautions for storage

None.

6.5 Nature and contents of container

White HDPE (GF4760) square bottles fitted with polyethylene sprinkler containing 70g of product.

Special precautions for disposal

Not applicable.