Alliance Pharmaceuticals Ireland

Thwart 26% w/w Cutaneous Solution

Salicylic Acid 26% w/w

For a full list of excipients, see section 6.1

Cutaneous solution.

Colourless to pale yellow solution.

Thwart is indicated for the treatment and removal of common and plantar warts, (verrucae).

For topical application.

Prior to application soak wart in warm water for five minutes. Remove loose tissue with a brush, emery board, pumice or abrasive sponge, being careful to avoid causing pin-point bleeding or abrading the surrounding healthy skin. Dry thoroughly with a towel not used by others to avoid contagion. Carefully apply Thwart twice to the wart using the brush applicator allowing the first application to dry before applying the second. Thereafter repeat treatment once daily or as directed by physician. Do not apply to surrounding healthy skin. Clinically visible improvement should occur in one to two weeks but maximum effect may be expected after four to six weeks.

There are no differences in dosage for children, adults or the elderly.

Hypersensitivity to salicylic acid or to any of the excipients.

Thwart should not be used by diabetics or patients with impaired blood circulation. Do not use if the wart or surrounding skin is inflamed or broken. Do not use on moles, birthmarks, unusual warts with hair growth, on facial warts, or in the anal or perineal region.

Thwart is for external use only. Do not permit contact with eyes or mucous membranes. If contact occurs flush with water for 15 minutes. Do not allow contact with normal skin around wart. Avoid using on areas of broken or damaged skin. Discontinue treatment if excessive irritation occurs. Excessive prolonged use of topical salicylic acid may result in symptoms of salicylism and must therefore be avoided.

There are no known interactions when used as indicated. However, topical salicylic acid may increase the absorption of other topically applied medicines. Concomitant use of Thwart and other topical medicines on the treated wart should therefore be avoided.

Whilst there are no known contra-indications to the use of Thwart during pregnancy and lactation, the safety has not been established. Thwart should therefore be used with caution or following professional advice.

None known.

A localised irritant reaction may occur if Thwart is applied to normal skin surrounding the wart. This may normally be controlled by temporarily discontinuing the use of Thwart and by being careful to apply the solution only to the wart itself when treatment is resumed.

Symptoms of systemic salicylate poisoning have been reported after the application of salicylic acid to large areas of skin and for prolonged periods. Salicylism may also occur in the unlikely event of large quantities being ingested. Salicylism is unlikely to occur if Thwart is used as indicated.

Pharmacotherapeutical group: Wart and anticorn preparations

ATC code: D11FA

Salicylic acid has bacteriostatic and fungicidal actions, but it is its keratolytic properties which are important for this medicinal product. When applied externally it produces slow and painless destruction of the epithelium. Salicylic acid is usually applied in the form of a paint in a collodian base (10 to 17%) or as a plaster (20 to 50%) to destroy warts or corns.

Salicylic acid may be percutaneously absorbed. However, there is no evidence of any systemic absorption from the use of Thwart.

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

Polyvinyl butyral B76

Dibutyl phthalate

Isopropyl alcohol

Butyl acetate

Acrylates copolymer B66

Not Applicable

3 years.

Do not store above 25°C.

The product is presented in a 10 ml amber glass bottle with cap brush assembly. The cap brush assembly comprises of a black cap and a white polythene wand nylon brush with stainless steel staple.

Thwart is flammable and should be kept away from flame or fire. Keep the bottle tightly capped when not in use. Do not allow the solution to drip from the brush onto the bottle neck thread, otherwise subsequent opening of the bottle may be difficult.

Alliance Pharmaceuticals Limited

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

United Kingdom

PA 943/9/1

November 2010