Sialanar® is an oral solution for children and adolescents aged 3 years and older with chronic neurological disorders for the management of chronic pathological drooling (severe sialorrhoea).1

It has raspberry flavouring, a titration schedule based upon patient’s weight and is suitable for administration orally and via feeding tubes.1

Designed for Children

Tailored titration for flexible and accurate dosing1

60% less volume vs.1mg/5ml glycopyrronium oral solutions, helping to improve patient acceptability and tolerability1-5

Minimal excipients to reduce toxicity risk - sugar, alcohol and sorbitol free 1,7,8

Why is volume important?
  • The dose volume is a major consideration for the acceptability of a liquid formulation6
  • The maximum recommended single dosing volume for paediatric liquid formulations for typically developing children is <5ml for children under 5 years and <10ml for children of 5 years and older5
  • Initial research suggests even Cerebral Palsy patients at EDACs level I may have a reduced dysphagia limit in comparison to typically developing children, with a median of 7ml.10
  • Eating, drinking and swallowing difficulties (dysphagia) are common in children with neurodisability6

Sialanar® is designed for children and has the lowest volumes for equivalent doses of any licensed glycopyrronium bromide oral solution.1-4

Why are excipients important?
  • Excipients are a necessary component of almost all medicines, but they may be present in quantities which are potentially harmful to babies and children6
  • Excipients used in adult formulations may not be appropriate for paediatric use so have the potential to lead to adverse effects8
  • Oral doses of sorbitol which are greater than 140mg/kg/day may result in increased gastrointestinal (GI) side effects, including osmotic diarrhoea, abdominal pain, bloating and GI discomfort7,8

Watch the excipients animation

Sialanar® is designed for children, using sucralose as a sweetener instead of sorbitol2,3,4 and is suitable for patients on a ketogenic diet (<5mg/ml carbohydrate)1,11

Why is treating drooling important?

Sialorrhoea can cause significant clinical problems and negatively impact quality of life for patients and carers12,13


Physical consequences

  • Posterior sialorrhoea: can lead to aspiration, increasing the risk of respiratory infections, hospitalisations and mortality14-16

  • Anterior sialorrhoea: can cause infections, macerated skin, interference with feeding and dehydration13

  • Aspiration can develop silently so may not be diagnosed prior to development of more serious lung issues14
  • Respiratory illness is the leading cause of hospitalisations and mortality in young people with cerebral palsy, 25% of patients (4-5 GMFCS) suffer from chronic respiratory problems16,17


Management of sialorrhoea is recommended to reduce risk factors for aspiration, helping to prevent further respiratory illness15

Psychosocial concerns

  • Social embarrassment, isolation and low self-esteem
  • Increased dependency and level of care
  • Barriers to education (damage and inability to share books / computers)

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 August 2023
  2. Glycopyrronium Bromide 1 mg/5 ml Oral Solution (Colonis Pharma) SmPC (September 2021) https://www.medicines.org.uk/emc/product/7344/smpc#gref - accessed August 2023
  3. Glycopyrronium Bromide 1 mg/5 ml Oral Solution (Rosemont Pharmaceuticals Limited) SmPC (December 2021) https://www.medicines.org.uk/emc/product/13136/smpc – accessed August 2023
  4. 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 – accessed August 2023
  5. Batchelor H & Marriot J. BJCP 2015. Formulations for Children: Problems and Solutions https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.12268 ) - accessed August 2023
  6. NPPG Positioning statement 2020-21 available at http://nppg.org.uk/choosing-an-oral-liquid-for-a-child/ - accessed August 2023
  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 – accessed August 2023
  9. Taylor H, Pennington L, Craig D, et al. Children with neurodisability and feeding difficulties: a UK survey of parent-delivered interventions. BMJ Paediatrics Open 2021;5:e001095. doi:10.1136/ bmjpo-2021-001095
  10. Schepers, F. V., van Hulst, K., Spek, B., Erasmus, C. E., & van den Engel-Hoek, L. (2022). Dysphagia limit in children with cerebral palsy aged 4 to 12 years. Developmental medicine and child neurology, 64(2), 253–258. https://doi.org/10.1111/dmcn.15031
  11. Data on file
  12. Collins A, et al. Management of drooling in children with cerebral palsy. Paediatrics & Child Heath 2020. 30(12): 425-429.
  13. Güvenç I.A. Sialorrhea: A guide to etiology, assessment, and management. In (Ed.), Salivary Glands - New Approaches in Diagnostics and Treatment. IntechOpen 2018. https://doi.org/10.5772/intechopen.82619.
  14. Erasmus C.E, et al. Swallowing problems in cerebral palsy. European Journal of Pediatrics 2012; 171: 409-414.
  15. American Academy for Cerebral Palsy and Developmental Medicine. Respiratory health in cerebral palsy. Available at: https://www.aacpdm.org/publications/care-pathways/respiratory-health-in-cerebral-palsy. accessed July 2023
  16. Gibson N, et al. Prevention and management of respiratory disease in young people with cerebral palsy: consensus statement. Developmental Medicine & Child Neurology 2021; 63: 172-182.
  17. Gregson E, et al. Pseudomonas aeruginosa infection in respiratory samples in children with neurodisability-to treat or not to treat? Eur J Pediatr. 2021; 180(9): 2897-2905.
  18. Parr J.R, Todhunter E, Pennington L, et al. Drooling Reduction Intervention randomized trial (DRI): comparing the efficacy and acceptability of hyoscine patches and glycopyrronium liquid on drooling in children with neurodisability. Arch Dis Child 2017; 1-6. Doi:10. 1136/ archdischild-2017-313763.
  19. Reid S.M, et al. Anticholinergic medications for reducing drooling in children with developmental disability. Developmental Medicine & Child Neurology 2019; 63(3): 346-353

UK-SIA-23-0109 | 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