Patient information leaflets for antihistamine sleep aid and laxative medicines

This guidance sets what is appropriate in patient information leaflets for antihistamine sleeping aids and laxatives.



Most medicines are used by patients safely and in accordance with the instructions for use on the patient information leaflet (PIL). There are a very small number of cases where medicines rarely may be misused or abused by patients.

In products that are known to be misused in a small proportion of cases, the PIL can help to ensure safe use by including appropriate warning messages. However, it is important to maintain a balance so that messages in the PIL do not direct patients to the possibility of misuse.