Safety

Summary of Sialanar's^® safety profile

Sialanar^® is an anticholinergic medicine, therefore is associated with typical class effects of anticholinergics. The side effects associated with Sialanar^® may be dose dependent and difficult to assess in a disabled child.

Please see the guidance below regarding dose titration and adverse event management:

• In the event of a known anticholinergic adverse reaction occurring when the dose is increased, the dose should be reduced to the previous lower dose and the event monitored.

• Constipation
• Urinary retention
• Pneumonia
• Allergic reaction
• Pyrexia
• Very hot weather
• Changes in behaviour

• Younger children may be more susceptible to adverse reactions and this should be kept in mind when any dose adjustments are carried out.

Following the dose titration period, the child’s sialorrhoea should be monitored, in conjunction with the carer at no longer than 3 monthly intervals, to assess changes in efficacy and/or tolerability over time, and the dose adjusted accordingly.
 
Continued use of Sialanar has been evaluated in children and adolescents aged 3 years and older for up to 9 months. With long-term continued use, Sialanar should be evaluated on a regular basis e.g 3 - 6 monthly.

For comprehensive information on Sialanar, please refer to the SmPC.¹