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 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.
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.
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. Pharmaceutical Particulars
6.1 List Of Excipients
Maize Starch PDR
Light Kaolin (irradiated)
Perfume compound 11899 Narom
Industrial Methylated Spirits 74.0
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
1. An internally plain, tin-plated can with a polyethylene sprinkler top containing 70G of product; or
2. White HDPE (GF4760) square bottles fitted with polyethylene sprinkler containing 70G of product.
3. One of the above in a combination pack with a tube of Mycota Cream in one of the following sizes 3g, 4g, 5g, 23g, 30g, 35g or 40g.
6.6 Special Precautions For Disposal And Other Handling
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
15 January 2003
10. Date Of Revision Of The Text
26th November 2009
11 DOSIMETRY (IF APPLICABLE)
Not Applicable
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)
Not Applicable
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