SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Dual Action Athlete’s Foot Spray

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient    % quantity

Tolnaftate    0.12 w/w

3 PHARMACEUTICAL FORM

Dry Powder Spray

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

The product is indicated for the adjunctive treatment and prevention of athlete’s foot (tinea pedis). It may also be helpful in conditions where tenderness and sweating cause skin irritation. It is also effective in other conditions, such as dhobie itch (tinea cruris) and prickly heat (miliaria).

4.2. Posology and Method of Administration

Adults, elderly and children over 2 Years

The affected area should be treated morning and night.

Treatment should continue for at least a week after the infection has cleared

^up.

Children under 2 Years

Not recommended except under the advice and supervision of a doctor For topical application to the skin.

Contra-indications

Hypersensitivity to any of the ingredients.

4.4. Special Warnings and Precautions for Use

If irritation or hypersensitivity occurs or if the condition does not improve within 10 days or becomes worse, treatment should be discontinued and medical advice sought.

Avoid contact with eyes.

4.5. Interactions with other Medicaments and other forms of Interaction

No clinically significant drug interactions known.

4.6. Pregnancy and Lactation

Safety in pregnancy has not been established. However, no teratogenic effects have been observed in clinical use. In studies in rats and mice, tolnaftate did not exert a deleterious effect on foetal or postnatal development.

It is not known whether topical tolnaftate is secreted into breast milk.

However no undesirable effects in breast fed infants whose mothers were using tolnaftate have been reported.

4.7. Effects on Ability to Drive and Use Machines

No adverse effects known.

4.8 Undesirable effects

Skin reactions occur rarely and may include irritation and contact dermatitis. 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.

Overdose

Not applicable.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Tolnaftate is an established antifungal agent which appears to produce its effects through inhibition of sterol synthesis.

5.2. Pharmacokinetic Properties

No data available.

5.3. Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are

additional to that already included.

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Talc EP

Denatured ethanol B grade Disteardimonium hectorite Dimethyl ether

6.2. Incompatibilities

Not applicable.

6.3. Shelf Life

24 months.

6.4 Special precautions for storage

Store below 25°C.

Caution: Flammable.

Pressurised container, protect from sunlight and do not expose to temperatures exceeding 50°C.

Do not pierce or burn, even after use.

Do not spray on a naked flame or any incandescent material.

Avoid inhalation.

Do not use near, or place container on, polished or painted surfaces. CFC-Free-does not contain CFC’s which damage ozone.

6.5. Nature and Contents of Container

Internally lacquered aluminium can fitted with a continuous spray valve and an actuator.

Pack size: 150 millilitres

6.6. Instruction for Use/Handling None.

7    MARKETING AUTHORISATION HOLDER

The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA

8    MARKETING AUTHORISATION NUMBER(S)

PL 00014/0520

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

26/04/1996 / 14/03/2001

DATE OF REVISION OF THE TEXT

01/07/2016