Mycota Spray
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mycota Spray.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Undecylenic Acid 3.90%w/w Dichlorophen 0.40 %w/w
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Cutaneous spray, solution A very pale yellow liquid.
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
For the treatment and prevention of athletes foot.
4.2. Posology and method of administration
Route of administration: Cutaneous use
There is no difference between the dosage for adults, children or the elderly. Treatment
Each night and morning wash and thoroughly dry the affected parts and spray on Mycota Spray. Ensure a generous application between the toes and each day wear clean socks or stockings dusted inside with Mycota Powder or sprayed lightly with Mycota Spray. Continue treatment for one week after all evidence of infection has disappeared.
Prevention
A light spray of Mycota Spray or a dusting of Mycota Powder daily inside clean socks or stockings will help prevent athletes foot.
4.3 Contraindications
Hypersensitivity to Undecylenic Acid, dichlorophen or any of the other ingredients.
Mycota Spray is for external use only. Do not allow the spray to enter the eyes, nose or other body orifices.
4.4. Special warnings and precautions for use
Do not apply to broken skin.
Treatment should be discontinued if irritation is severe.
Caution, Mycota Spray is flammable: Do not use near fire or flame.
Pressurised container: protect from sunlight and do not expose to temperatures exceeding 50°C.
Do not pierce or burn the can, even after use.
Do not spray on a naked flame or any incandescent material.
Do not use near, and do not place the container on, polished or painted surf aces.
Keep out of the reach of children.
4.5. Interactions with other medicinal products and other forms of interaction
None known.
4.6. Pregnancy and lactation
As with all medicinal compounds care should be taken when administering the product to pregnant or lactating women.
4.7. Effects on ability to drive and use machines
No or negligible influence.
Undesirable effects
4.8
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
Owing to the nature of this product and its clinical indications it is highly unlikely that overdose can occur.
Treatment
None stated.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Other antifungals for topical use D01A E
Undecylenic Acid has antifungal properties being applied topically in the prophylaxis and treatment of dermatophytic infections of superficial areas. Dichlorophen is used as a fungicide.
5.2 Pharmacokinetic properties
Concentrations of Undecylenic Acid greater than 1 % may cause skin irritation if applied to mucous membranes. It is usually applied to the skin in concentrations of 2-10% and its antifungal activity is greatest at acid pH. As Dichlorophen is included for topical application it is considered that pharmacokinetic data is 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
Isopropyl Alcohol Dipropylene Glycol Perfume compound SN27673 Butane/Propane Mixture
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Protect from sunlight and do not expose to temperatures exceeding 30°C.
6.5. Nature and contents of container
Internally lacquered, three piece, tin plate aerosol can with standard aerosol valve and high density polyethylene cap. Can contains 100ml of product
6.6. Instructions for use and handling, (and disposal) Not applicable.
Thornton & Ross Limited
Linthwaite
Huddersfield
West Yorkshire
HD75QH
United Kingdom.
8. MARKETING AUTHORISATION NUMBER(S)
PL: 00240/0069.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
6th September 2002.
10 DATE OF REVISION OF THE TEXT
31/12/2014