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 below guidance around managing dose titration and adverse events:

• 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.
   > If the event does not resolve, treatment should be discontinued.

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

Following dose titration, the child's sialorrhoea should be monitored in conjunction with the carer at no longer than 3 monthly intervals. This is to assess changes in efficacy and/or tolerability over time, and the dose adjusted accordingly.

For full information on Sialanar^®’s side effect profile please refer to the SmPC.¹