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Mycota Spray

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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