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About Sialanar®

Sialanar® is licensed for the symptomatic treatment of severe sialorrhoea (chronic pathological drooling) due to chronic neurological disorders of childhood onset in patients aged 3 years and older.1

It has raspberry flavouring, a titration schedule based on the patient’s weight and is suitable for oral administration or via feeding tubes.1

Designed for Children

Tailored titration for flexible and accurate dosing1

Due to a greater bioavailability, Sialanar® dose volumes are 20% lower than other glycopyrronium bromide oral solutions of the same concentration (2mg/5ml),1,2,3 helping to improve patient acceptability4

Minimal excipients to reduce toxicity risk - sugar, alcohol and sorbitol free 1,5-7

Why is volume important?

 

  • The dose volume is a major consideration for the acceptability of a liquid formulation5,6
  • The maximum recommended single oral dosing volume for typically developing children is 5ml for children below 4 years and 10ml for children aged between 4 to 12 years.4
  • Eating, drinking and swallowing difficulties (dysphagia) are common in children with neurodisability8
  • A study identified that children with cerebral palsy (CP) have a significantly lower dysphagia limit compared to typically developing children. At EDACS level I, children with CP had a dysphagia limit of 7ml, compared to 22ml in typically developing children9
Why are excipients important
  • Excipients are a necessary component of almost all medicines; however, high excipient content and/or the presence of certain excipients may cause harm to babies and children5
  • Excipients used in adult formulations may not be appropriate for paediatric use so have the potential to lead to adverse effects7
  • 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 discomfort6,7

Sialanar® is designed for children, using sucralose as a sweetener instead of sorbitol1 and is ketogenic diet friendly (<5mg/ml carbohydrate)1

Why is treating drooling important?

Sialorrhoea can cause significant clinical problems and negatively impact quality of life for patients and carers14,15

Physical consequences

  • Posterior sialorrhoea: can lead to aspiration, increasing the risk of respiratory infections, hospitalisations and mortality16-18

  • Anterior sialorrhoea: can cause infections, macerated skin, interference with feeding and dehydration15,16

  • Aspiration can develop silently so may not be diagnosed prior to development of more serious lung issues16
  • 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 problems18,19


Management of sialorrhoea is recommended to reduce risk factors for aspiration, helping to prevent further respiratory illness17

Psychosocial concerns15,17,20,21

  • Social embarrassment, isolation and low self-esteem
  • Increased dependency on parents and carers leading to a higher burden of care 
  • Barriers to education (drooling can damage books, computers and other belongings, which may discourage children from sharing them with their peers).

Resources

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

Resources

Dosing and Titration

Head to this section to find out more about the dosing and titration schedule for Sialanar®.

Dosing and Titration

Clinical Evidence

The first and only double-blind, randomised, placebo-controlled study of oral anticholinergics in sialorrhoea that has investigated efficacy, safety and impact on quality of life22,23 continued as an open-label study extension (OLSE)23 

Find out more on the Clinical Evidence page

References

  1. Sialanar® SmPC (August 2026) https://www.medicines.org.uk/emc/product/2301 
  2. BNFC Glycopyrronium Bromide https://bnfc.nice.org.uk/drugs/ glycopyrronium-bromide/.
  3. Colonis Pharma Ltd. (January 2026) Glycopyrronium Bromide 2mg/5mL Oral Solution SmPC. Available at: emc.medicines.org.uk
  4. Batchelor H & Marriot J. BJCP 2015. Formulations for Children: Problems and Solutions https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.12268 ) 
  5. NPPG Positioning statement 2020-21 available at http://nppg.org.uk/choosing-an-oral-liquid-for-a-child/ 
  6. Rouaz K, et al. Excipients in the paediatric population: a review. Pharmaceutics 2021; 13(3): 387.
  7. 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 
  8. 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
  9. 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
  10. Glycopyrronium Bromide 1 mg/5 ml Oral Solution (Colonis Pharma) SmPC (November 2025)  https://www.medicines.org.uk/emc/product/7344/smpc
  11. Glycopyrronium Bromide 1 mg/5 ml Oral Solution (Rosemont Pharmaceuticals Limited) SmPC (August 2026) https://www.medicines.org.uk/emc/product/13136/smpc
  12. Glycopyrronium Bromide 1 mg/5 ml Oral Solution (Strandhaven Limited t/a Somex Pharma UK Limited) SmPC (June 2026) https://www.medicines.org.uk/emc/product/14104/smpc
  13. Data on file
  14. Collins A, et al. Management of drooling in children with cerebral palsy. Paediatrics & Child Heath 2020. 30(12): 425-429.
  15. 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.
  16. Erasmus C.E, et al. Swallowing problems in cerebral palsy. European Journal of Pediatrics 2012; 171: 409-414.
  17. 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
  18. 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.
  19. 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.
  20. Walshe M, Smith M, Pennington L. Interventions for drooling in children with cerebral palsy. Cochrane Database Syst Rev 2012;11:CD008624.
  21. Orriëns L.B., et al. The when, why and how of using glycopyrronium to diminish drooling in children with neurodevelopmental disabilities: Implications for clinical practice. Eur J Paediatr Neurol 2024; 51: 24–31.
  22. 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 
  23. Fayoux P, et al. Glycopyrronium 320 μg/mL in children and adolescents with severe sialorrhoea and neurodisabilities: An open-label study extension of the SALIVA trial. Dev Med Child Neurol. 2025; 00:1–10.DOI: 10.1111/dmcn.16251  

Accessed August 2026

 

UK-SIA-26-0020 | August 2026

Adverse Event Reporting Information

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: +44 333 200 1866 E-Mail: medinfo@proveca.com

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