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Superdrug Athletes Foot Powder

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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Scholl Athletes Foot Powder Superdrug Athletes Foot Powder

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Tolnaftate 1.0%w/w

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Powder for topical application

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the prevention and treatment of Athlete’s Foot.

4.2 Posology and method of administration

Wash and dry infected area, and apply twice daily or as directed by your doctor. Dust feet liberally, especially between toes. For added protection dust on socks, hosiery and inside shoes. Continue treatment for two weeks after symptoms disappear.

4.3    Contraindications

Not recommended for nail or scalp infections.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4    Special warnings and precautions for use

For external use only

Keep out of eyes

If symptoms do not improve within 10 days, discontinue use and consult your doctor

Keep out of the reach and sight of children

4.5 Interaction with other medicinal products and other forms of interaction

Not relevant to topical use

4.6 Pregnancy and lactation

No known restrictions.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

Adverse reactions have been ranked under headings of frequency using the following convention:

Very common

> 1/10

Common

> 1/100 to > 1/10

Uncommon

> 1/1,000 to < 1/100

Rare

> 1/10,000 to < 1/1,000

Very rare

<1/10,000

Within easy frequency grouping, undesirable effects are presented in order of decreasing seriousness.

System Organ Class

Frequency

Skin and subcutaneous tissue disorder

Unknown

Skin reactions Skin irritation Pruritis

Contact dermatitis

4.9 Overdose

Not relevant to topical use.

PHARMACOLOGICAL PROPERTIES

5


5.1 Pharmacodynamic properties

Tolnaftate

Topical antifungal agent (ATC Classification: D01A E)

5.2 Pharmacokinetic properties

Not applicable for a topical dosage form of this type

5.3 Preclinical safety data

None stated

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Talc

Starch

6.2 Incompatibilities

None stated.

6.3    Shelf life

24 months, unopened

6.4    Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

High density poly-ethylene container with sifter assembly. 75g of product

Special precautions for disposal

6.6


No special precautions required

7 MARKETING AUTHORISATION HOLDER

Scholl Consumer Products Ltd

103-105 Bath Road

Slough

SL1 3UH

UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 00587/0007

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

24/04/1985 / 12/01/2005

10 DATE OF REVISION OF THE TEXT

21/01/2013