Mycota

Mycota Powder

Quantity/dose unit or % quantity

Zinc Undecylenate Ph.Eur 20.00 %w/w

Undecylenic Acid Ph.Eur 2.00 %w/w

Excipients(s) with known effect:

Perfume Compound 11899 Narom (Contains Euganol) 0.143 % w/w

For full list of excipients, see section 6.1

Cutaneous powder.

A cream coloured powder free from lumps; perfumed.

For the treatment and prevention of athlete's foot.

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.

Hypersensitivity to any of the ingredients.

For external use only.

Contact with 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.

Excipient warnings:

This medicine contains fragrance with Euganol, which may cause an allergic reaction.

No clinically significant interactions known.

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.

No or negligible influence.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

D01A E - Other antifungals for topical use

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

Not applicable.

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

Maize Starch

Light Kaolin

Perfume Compound 11899 Narom (Contains Euganol)

Not applicable.

36 months unopened.

None.

70g White polypropylene (PP) container with polypropylene (PP) sifter top.

Not applicable.

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

PL 00240/0061

15^th January 2003

15/10/2020