Guidance

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.

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Documents

Patient information leaflets for antihistamine sleep aid and laxative medicines

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Details

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.

Published 29 December 2014