Summary of Sialanar®’s safety profile

Sialanar® is an anticholinergic, therefore is associated with typical class effects of anticholinergic medicines. The side effects associated with Sialanar® may be dose dependent and difficult to assess in a disabled child.

Please see the below guidance around managing dose titration and adverse events:

• In the event of a known anticholinergic adverse reaction occurring when the dose is increased, the dose should be reduced to the previous lower dose and the event monitored.
   > If the event does not resolve, treatment should be discontinued.

• Younger children may be more susceptible to adverse reactions and this should be kept in mind when any dose adjustments are carried out.

Following dose titration, the child's sialorrhoea should be monitored in conjunction with the carer at no longer than 3 monthly intervals. This is to assess changes in efficacy and/or tolerability over time, and the dose adjusted accordingly.

For full information on Sialanar®’s side effect profile please refer to the SmPC.1

Resources

Visit the resources section to find product support materials for patients/carers and educational resources for healthcare professionals.
Resources

References

  1. Sialanar® SmPC (January 2023) https://www.medicines.org.uk/emc/product/2301 - accessed July 2023
  2. Parr JR, Todhunter E, Pennington L, et al. Drooling Reduction Intervention randomised trial (DRI): comparing the efficacy and acceptability of hyoscine patches and glycopyrronium liquid on drooling in children with neurodisability. Arch Dis Child 2017;0: 1-6. DOI: 10. 1136/archdischild-2017-313763
  3. Reid S M, et al.; Anticholinergic medications for reducing drooling in children with developmental disability. Developmental Medicine & Child Neurology, 2019 Mac Keith Press. DOI: 10.111/dmcn.14350

UK-SIA-23-0114 | August 2023

Please see below for information on how to report an adverse event in the UK or Republic of Ireland:

UK
Adverse events should be reported. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Proveca Limited. Phone: 0333 200 1866 E-Mail: medinfo@proveca.com

Republic of Ireland
Adverse events should be reported. Reporting forms and information can be found at: www.hpra.ie.
Adverse events should also be reported to Proveca Limited. Phone: +44 333 200 1866 E-Mail: medinfo@proveca.com

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