SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Scholl Complete Com Treatment Kit 40% w/w Medicated Plasters

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Salicylic acid 40.00%w/w

For the full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Medicated plaster

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the treatment of corns Topical application to the skin

4.2 Posology and method of administration

Adults and Children aged 16 years and over

For best results the feet should be washed and dried before use. One medicated disc should be placed on the corn and covered with a cover plaster. This should be repeated daily until the corn can be removed. Treatment should not continue for more than two weeks, except under medical advice.

Then continue to protect the affected area with the corn foam cushion as required.

Should not be used in children under 16 years, except following a doctor’s recommendation.

4.3 Contraindications

•    Not to be used by diabetics or patients or patients with severe circulatory disorders or suffering from neuropathy, except following a doctor’s prescription or recommendation.

•    Not to be used if the corn or surrounding skin is broken or inflamed.

•    Not to be used in patients who are hypersensitive to salicylic acid (or other NSAIDs) or to any excipients in section 6.1

•    Not to be used by pregnant or breastfeeding patients (see section 4.6)

Not suitable for application to face, ano-genital region, or large areas of the body.

4.4 Special warnings and precautions for use

Discontinue use and remove plaster if excessive discomfort or irritation is experienced or if sensitivity develops.

Do not apply to normal skin.

For external use only.

4.5 Interaction with other medicinal products and other forms of interaction

None stated.

4.6 Pregnancy and lactation

Pregnancy:

There is no data on the use of topical salicylic acid in pregnant women. Therefore the use of this product during pregnancy is contraindicated.

Breast feeding:

Salicylates should be given with caution to breast-feeding mothers because of the possible risk of Reye’s syndrome in nursing infants and there is no data on the use of topical salicylic acid in breast feeding women. Therefore the use of this product during pregnancy is contraindicated.

Fertility:

There is no information on the effects of topical salicylic acid and fertility

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

Local irritation or dermatitis may occur if applied to normal healthy skin surrounding the corn. This may be controlled by temporarily discontinuing use and by carefully applying only to the corn when the treatment is resumed.

4.9    Overdose

Salicylic acid is readily absorbed through the skin, and symptoms of acute systemic salicylate poisoning have been reported after excessive use. Symptoms include dizziness, tinnitus, deafness, sweating, nausea and vomiting, headache, and confusion, and may be controlled by reducing the dosage.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Salicylic acid: keratolytic agent

Pharmacotherapuetic classification (ATC): D11 AF Pharmacodynamic Effects

Salicylates have analgesic, anti-inflammatory and antipyretic properties much of which is ascribed to an inhibition of prostaglandin synthesis. However, the relevant pharmacodynamic effect of salicylic acid for this product is its “keratolytic” action. The mechanism of this effect has been investigated in animals and in man, and appears to be due to a lipid modifying effect in the lipid bilayers of the skin rather than a keratolytic action. It is thought that the salicylic acid increases lipid structure fluidity so allowing moisture to penetrate into areas surrounding the corn. This in turn leads to a pressure build up causing the corn to be pushed upwards. It has been suggested that the occlusive nature of the plaster enhances this effect.

5.2 Pharmacokinetic properties

Salicylic acid can be absorbed following topical application.

5.3 Preclinical safety data

No other information relevant to the prescriber other than that already stated in other sections of the SPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Polyvinyl Alkyl Ether (Low Molecular Weight)

Polyvinyl Alkyl Ether (High Molecular Weight) Titanium Dioxide Liquid Paraffin

4,4’-Thio-Bis (2-Tert-butyl-5-Mehtylphenol)

Red Iron Oxide Black Iron Oxide

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years unopened.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Sachet Contents: 6 medicated adhesive plasters mounted onto a silicone backed paper.

9 foam corn cushions mounted onto a silicone backed paper.

6.6 Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Scholl Consumer Products Ltd

103-105 Bath Road

Slough

SL1 3UH

UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 00587/5015R

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

17/01/2008

10 DATE OF REVISION OF THE TEXT

01/05/2013