SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Callous Removal Pads 40% w/w Medicated Plasters

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Salicylic acid    40.0% w/w

For full excipients, see section 6.1

3. PHARMACEUTICAL FORM

Medicated plaster

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the treatment of calluses Topical application to the skin

4.2    Posology and method of administration

Adults and Children aged 16 years and over

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

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 with severe circulatory disorders, except following a doctor’s prescription or recommendation.

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

Not to be used in patients who are hypersensitive to salicylic acid or to any excipients in section 6.1.

It is generally recommended that patients who have had hypersensitivity reaction to NSAIDs should avoid all NSAIDs.

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

Extra caution should be taken in patients with significant peripheral neuropathy and diabetic patients at risk of neuropathic ulcer and or impaired peripheral circulation.

Protect surrounding skin and avoid broken skin.

Not suitable for application to face, anogenital region, or large areas.

Preparations containing high concentrations of salicylic acid can cause skin ulceration or erosion. Healthy skin surrounding verruca, corns, and calluses should be protected with soft paraffin or specially designed plasters when such preparations are being used.

To minimise absorption after topical application salicyclic acid should not be used for prolonged periods, in high concentrations, on large areas of the body, or inflamed or broken skin.

Contact with mouth, eyes and other mucous membranes should be avoided.

4.5. Interactions with other medicinal products and other forms of interaction

None stated.

4.6 Fertility, pregnancy and lactation

Pregnancy:

There are no data on the topical use of salicylic acid in pregnant women.

Breast feeding:

Salicylates should be given with caution to breast-feeding mothers because of the possible risk of Reye's syndrome in nursing infants.

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 callus. This may be controlled by temporarily discontinuing use and by carefully applying only to the callus when the treatment is resumed.

Salicylism can also occur following excessive topical application of salicylates. Symptoms include dizziness, tinnitus, deafness, sweating, nausea and vomiting, headache and confusion and may be controlled by reducing the dosage.

4.9    Overdose

Salicylic acid is readily absorbed through the skin, and symptoms of acute systemic salicylate poisoning have been reported after excessive use.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Salicylic acid: Keratolytic agent Pharmacotherapeutic group (ATC code): D11A F

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 callus. This in turn leads to a pressure build up causing the callus 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

None stated.

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-methylphenol) Red iron oxide Black iron oxide Backing material

6.2.    Incompatibilities

None stated.

6.3    Shelf life

3 years unopened 6 weeks after first opening

6.4    Special precautions for    storage

Do not store above 25°C

6.5    Nature and contents of    container

One sachet containing 2, 4 or 6 medicated adhesive discs. Each pack includes one strip of ecru coloured twill cloth cover plasters covered with a pressure sensitive adhesive on one side for the standard product, or a reusable, translucent polymer gel cover plaster which is naturally tacky on one side, for the “polymer gel” variant. The sachet and cover plasters are flow wrapped in polypropylene film or packed in cardboard cartons.

Not all pack sizes may be marketed.

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

PL 00587/5000R

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION 17/01/2008

10 DATE OF REVISION OF THE TEXT

21/01/2013