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DUAL ACTION ATHLETES FOOT SPRAY

Active substance(s): TOLNAFTATE / TOLNAFTATE / TOLNAFTATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Dual Action Athletes Foot Spray

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient Tolnaftate % quantity 0.12 w/w

3

PHARMACEUTICAL FORM
Dry Powder Spray

4
4.1

CLINICAL PARTICULARS
Therapeutic indications
The product is indicated for the adjunctive treatment and prevention of athletes 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.

4.3.

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.

4.9.

Overdose Not applicable.

5
5.1

PHARMACOLOGICAL PROPERTIES
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
6.1

PHARMACEUTICAL PARTICULARS
List of excipients
Talc extra 5/0 -M20 DEC 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 25C. Caution: Flammable. Pressurised container, protect from sunlight and do not expose to temperatures exceeding 50C. 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. CFCFree-does not contain CFCs 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

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
26/04/1996 / 14/03/2001

10

DATE OF REVISION OF THE TEXT
01/08/2001

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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