Summary of Product Characteristics (SmPC) - Mycota powder
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
Excipients(s) with known effect:
Perfume Compound 11899 Narom (Contains Euganol) 0.143 % 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 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.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
5.2 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 Compound 11899 Narom (Contains Euganol)
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
70g White polypropylene (PP) container with polypropylene (PP) sifter top.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Thornton & Ross Limited
Linthwaite
Huddersfield
West Yorkshire
HD7 5QH
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 00240/0061
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
15th January 2003
10 DATE OF REVISION OF THE TEXT
15/10/2020