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Sialanar®

About Sialanar® (320mcg/ml glycopyrronium equivalent to 400mcg/ml glycopyrronium bromide) and Prescribing Information

Sialanar® received a European Paediatric Use Marketing Authorisation (PUMA) on 15th September 2016 for the symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.

NICE published its latest evidence summary on “Severe sialorrhoea (drooling) in children and young people with chronic neurological disorders: oral glycopyrronium bromide” in February 2017

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Prescribing Information (UK)

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Summary of Product Characteristics (UK)

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Healthcare Educational Materials (UK)

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Prescribing Information (Ireland)

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Summary of Product Characteristics (Ireland)

NICE Evidence Summary

https://www.nice.org.uk/advice/es5/chapter/Key-points

Benefits of Sialanar®

The illustrations below do not represent the colour of Sialanar® or other glycopyrronium solutions

  • Concentrated solution (2mg/5ml glycopyrronium bromide) therefore relatively small volume to swallow
  • Sialanar® has an oral dosing syringe to easily titrate the exact dose based on weight and titration level
  • Raspberry flavouring increases the palatability for the patient
  • Sialanar® requires no further manipulation and is licensed to be administered via feeding tubes
  • Sugar-free solution with minimal excipients

Product Sialanar®
Mode of action anticholinergic
Composition 320mcg/ml glycopyrronium equivalent to 400mcg/ml glycopyrronium bromide
Pack Sizes 250ml or 60ml amber glass bottle (includes one 8 ml low density polyethylene oral syringe and one syringe adaptor)
Appearance Clear and colourless
Flavour Raspberry
Viscosity Aqueous solution
Sweetener Sucralose (E955)
Lactose-free Yes
Carbohydrate <5mg/ml
Gluten-free Yes
Storage conditions Do not store above 25°C
Suitable for feeding tubes Yes – suitable for GJ, PEG and Nasogastric
Sodium Free Yes
Sortbitol Free Yes
Fructose free Yes
Aspartame Free Yes
Tartrazine Free Yes
Shelf Life unopened 3 years
Shelf life once opened 2 months

Please see information below to report adverse events in the 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

Please see information below to report adverse events in the 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

Please refer to SMPC for dosing information.

UK-SIA-23-0039

Updated March 2023