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

Reporting of side effects

UK
If you/your child experience(s) any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard

Republic of Ireland
If you/your child experience(s) any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. Adverse event should be reported, reporting forms and information can be found at: www.hpra.ie.

By reporting side effects, you can help provide more information on the safety of this medicine.

Side effects should also be reported to Proveca Limited. Phone: +44 333 200 1866 E-Mail: medinfo@proveca.com

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UK-SIA-23-0102 | August 2023