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Changes highlighted in red text: 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.