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Hyoscine hydrobromide patches drug safety update

Anticholinergic side effects

July 25th 2023

Tagged: MHRA alert

By MHRA

The MHRA has published a Drug Safety Update about hyoscine hydrobromide patches (Scopoderm 1.5 mg Patch or Scopoderm TTS Patch.

There have been a small number of reports of serious and life-threatening anticholinergic side effects associated with these hyoscine hydrobromide patches, particularly when used outside the licence.

Hyoscine hydrobromide patches (Scopoderm 1.5 mg Patch or Scopoderm TTS Patch) are licensed for the prevention of motion or travel sickness symptoms (for example, nausea, vomiting and vertigo) in adults and children aged 10 years or older. Each patch lasts up to 72 hours.

There is widespread use of hyoscine hydrobromide patches outside of the licence, including for the management of hypersecretion or hypersalivation and the management of nausea and vomiting.

Children and elderly people are more susceptible to anticholinergic toxicity. Signs and symptoms of serious side effects in need of vigilance include high temperature, inability to urinate, confusion, disorientation, seeing or hearing things that are not there, fits or convulsions, reduced consciousness, and breathing difficulties.

 Healthcare professionals, patients, parents and carers should be aware of the signs and symptoms of serious side effects and the need to seek medical help if they occur.