Designed for Children

Sialanar® (400mcg/ml glycopyrronium bromide equivalent to 320mcg/ml glycopyrronium) is licensed for the symptomatic treatment of severe sialorrhoea in children and adolescents aged 3 years and older with chronic neurological disorders.1

New clinical data from the SALIVA Trial - the first and only double-blind, randomised, placebo-controlled study in sialorrhoea, that has investigated efficacy, tolerability and quality of life.2
Sialanar is Designed for Children

Tailored titration for flexible and accurate dosing1

60% less volume vs. 1mg/5ml glycopyrronium bromide oral solutions, helping to improve patient acceptability1,3-6

Minimal excipients to reduce toxicity risk - sugar, alcohol and sorbitol free1,7,8

Use the links below to explore

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References

  1. Sialanar® SmPC (January 2023) https://www.medicines.org.uk/emc/product/2301 
  2. Fayoux P et al., Glycopyrronium 320 μg/mL in children and adolescents with severe sialorrhoea and neurodisabilities: A randomized, double-blind, placebo-controlled trial. Developmental Medicine & Child Neurology 2024; 00: 1–9. DOI:10.1111/dmcn.15841. https://onlinelibrary.wiley.com/doi/10.1111/dmcn.15841 
  3. Glycopyrronium Bromide 1 mg/5 ml Oral Solution (Colonis Pharma) SmPC (September 2021) https://www.medicines.org.uk/emc/product/7344/smpc#gref 
  4. Glycopyrronium Bromide 1 mg/5 ml Oral Solution (Rosemont Pharmaceuticals Limited) SmPC (December 2021) https://www.medicines.org.uk/emc/product/13136/smpc 
  5. Glycopyrronium Bromide 1 mg/5 ml Oral Solution (Strandhaven Limited t/a Somex Pharma UK Limited) SmPC (July 2022) https://www.medicines.org.uk/emc/product/14104/smpc 
  6. Batchelor H & Marriot J. BJCP 2015. Formulations for Children: Problems and Solutions https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.12268 
  7. Rouaz K, et al. Excipients in the paediatric population: a review. Pharmaceutics 2021; 13(3): 387.
  8. Arthur S. How to identify and manage ‘problem’ excipients in medicines for children. The Pharmaceutical Journal 2017. Available at:https://pharmaceutical-journal.com/article/ld/how-to-identify-and-manage-problem-excipients-in-medicines-for-children 
  9. Reddihough, D et al. J of Paediatr and Child Health 2021, 37: 183-186

All reference links accessed April 2024

UK-SIA-24-0016 | April 2024

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