Verruca Removal System 40% W/W Medicated Plasters
SUMMARY OF PRODUCT CHARACTERISTICS
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 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 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 Interactions 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.
Overdose
4.9
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.
6.1 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
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
SL13UH
UK
8. MARKETING AUTHORISATION NUMBER
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