Summary of Product Characteristics (SmPC) - Mycota cream
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
Excipient(s) with known effect:
Perfume Compound 11899 Narom (Contains Euganol) HSE 0.2% w/w
Emulsifying Wax (Contains Cetostearyl alcohol and Sodium laurilsulfate) BP 15.0 % 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.
4.3 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 sight and reach 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.
Excipient warnings:
This medicine contains Emulsifying wax with 1.4% w/w Sodium laurilsulfate. Sodium laurilsulfate may cause local skin reactions (such as stinging or burning sensation) or increase skin reactions caused by other products when applied on the same area.
This medicine contains Emulsifying wax with 1.36% w/w Cetostearyl alcohol. Cetosteryl alcohol may cause local skin reactions (e.g. contact dermatitis).
This medicine contains fragrance with Euganol, which may cause an allergic reaction.
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.
5 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 (Contains Cetostearyl alcohol and Sodium laurilsulfate) Perfume Compound 11899 NAROM HSE (Contains Euganol) 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
06/10/2020