The revised SPC contains information on the main metabolite of prilocaine, o-toluidine, which has been shown to be genotoxic and is also carcinogenic in preclinical toxicological studies evaluating chronic exposure. However, the clinical relevance of the observed carcinogenicity following chronic exposure compared to the intermittent use of prilocaine for local anaesthesia is unknown.
For full prescribing information please see link to the SPC below.