Occlusal

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4.8       Undesirable effects

Undesirable effects are listed by MedDRA System Organ Classes.

Assessment of undesirable effects is based on the following frequency groupings:

Very common: ≥1/10

Common: ≥1/100 to <1/10

Uncommon: ≥1/1,000 to <1/100

Rare: ≥1/10,000 to <1/1,000

Very rare: <1/10,000

Not known: cannot be estimated from the available data

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

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4.3       Contraindications

Hypersensitivity to salicylic acid or to any of the excipients.

Occlusal 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.

4.4       Special warnings and precautions for use

Occlusal 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.

4.5       Interaction with other medicinal products and other forms of interaction

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 Occlusal and other topical medicines on the treated wart should therefore be avoided.

4.6       Fertility, pregnancy and lactation

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

4.7       Effects on ability to drive and use machines

None known.

4.9       Overdose

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 Occlusal is used as indicated.

5.         PHARMACOLOGICAL PROPERTIES

5.1       Pharmacodynamic properties

Pharmacotherapeutic 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.

5.2       Pharmacokinetic properties

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

5.3       Preclinical safety data

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