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

Flag of the United Kingdom

Prescribing Information (UK)

Flag of the United Kingdom

Summary of Product Characteristics (UK)

Flag of the United Kingdom

Healthcare Educational Materials (UK)

Flag of Ireland

Prescribing Information (Ireland)

Flag of Ireland

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