This information is intended for use by health professionals

1. Name of the medicinal product

Scholl Verruca Removal System 40% w/w Medicated Plasters

Verruca Removal System 40% w/w Medicated Plasters

2. Qualitative and quantitative composition

Salicylic acid40.00%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 common warts on the feet and hands.

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. Select a medicated disc from those supplied which best fits the size of the wart. Leave medicated disc in place on wart fro 48 hours and repeat treatment. Treatment should not continue for more than twelve 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 or patients with severe circulatory disorders or suffering from neuropathy, except following a doctor's prescription or recommendation.

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

• Not to be used on moles, birthmarks, warts with hair growing from them, genital warts or warts on the face or mucous membranes.

• 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)

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

Not relevant to cutaneous use

4.6 Fertility, 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 wart. This may be controlled by temporarily discontinuing use and by carefully applying only to the wart 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

Keratolytics

Mechanism of Action

The mechanism of action of salicylic acid has not been established.

Pharmacodynamics 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 reduction of intercellular cohesion and/or increasing endogenous hydration. The exact mechanism of action however has not yet been elucidated.

5.2 Pharmacokinetic properties

Salicylic acid can be absorbed following topical application. Plasma salicylate is largely protein-bound and is metabolised by oxidation and conjugation with some excreted unchanged. The elimination of salicylate follows first order kinetics with a half-life of about four hours except with high systemic doses which result in saturation of the elimination mechanism.

5.3 Preclinical safety data

Salicylic acid has a low acute toxicity with oral LD50 values of 480mg/kg in the mouse and 891 mg/kg in the rat. It is a dermal irritant but systemic toxicity from application of Scholl Verruca Removal System is extremely unlikely because of the small quantities applied.

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'-Thiobis (2-tert-butyl-5-mehtylphenol)

Red iron oxide

Black iron oxide

Backing material

Twill cloth

Polyethylene foam-coated plaster (closed cell)

6.2 Incompatibilities

Not relevant

6.3 Shelf life

3 years unopened.

6 weeks after first opening.

6.4 Special precautions for storage

Store below 25°C

6.5 Nature and contents of container

Sachet

Contents:

Three separate sachets each containing fifteen medicated adhesive discs. Each set of fifteen discs comprised of three sizes of disc (3x 5).

Each pack contains fifteen cover plasters.

These may be composed of an ecru coloured twill cloth for the standard product or tan coloured closed cell polyethylene foam coated plasters for the washproof variant. Both types of plaster are coated with a pressure sensitive adhesive.

6.6 Special precautions for disposal and other handling

Any unused medicinal product or waste 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 / 0038

9. Date of first authorisation/renewal of the authorisation

27th June 1994 / 26th June 1999

10. Date of revision of the text

22/03/2013