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HEALTHCARE EDUCATIONAL INFORMATION

Healthcare Educational Materials can be printed from here and extra copies of the adverse event recording forms for patient notes can be printed from here.

Sialanar (glycopyrronium 320 µg/ml) Oral Solution ‐ risk minimisation of anticholinergic side effects

Anticholinergic side effects associated with the use of Sialanar may be dose dependent and difficult to assess in a  disabled child.
Sialanar is approved for symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children  and adolescents aged 3 years and older with chronic neurological disorders.

Sialanar should be prescribed by physicians specialised in the treatment of paediatric patients with neurological  disorders, who should also conduct monitoring and dose changes.

Due to the lack of long‐term safety data, Sialanar is recommended for short ‐term intermittent use.

The treating physician should bring to the attention of the patient’s parent/ caregiver the possible common  anticholinergic side effects shown in the checklist below that may occur with the use of Sialanar and provide advice  on how to recognize and prevent or minimise them.

During the course of the treatment anticholinergic reactions should be assessed in the patient by the physician,  indicating the date and result of the assessment using the labels provided, which should be attached to the  patient’s notes. (The format of the checklist is provided below for information.)

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It is important to make sure an acurate dose is given each time, in order to prevent harmful effects of Sialanar seen  with dosing errors or overdose. In order to give Sialanar safely the dosing table on the Reminder Card for Caregivers  should be completed by the physician with the proposed dose at each dose change. The Reminder Card for  Caregivers should be handed to patient’s parents/caregivers.

Important information to be brought to the attention of the parent/caregiver:

  • To give Sialanar exactly as the doctor has directed.
  • To check with the treating doctor if parent/caregiver is not sure about the right dose.
  • To give Sialanar at least one hour before or two hours after meals.
  • To avoid giving Sialanar with a high fat meal as it reduces the amount of medicine absorbed.
  • Obligation to measure the dose of Sialanar using the special measuring device (oral syringe) provided, and check  the level on the syringe.
  • Not to increase the dose without the doctor’s permission.
  • To stop giving Sialanar and seek urgent medical advice if any of the following side effects occur:
    • Constipation
    • Urinary retention
    • Pneumonia  
    • Allergic reaction
  • To inform that side effects can sometimes be difficult to recognise in patients with neurological problems who  cannot easily express how they feel. To decrease the dose to the previous one and contact the treating doctor if  the parent/caregiver thinks that a troublesome side effect is occurring after increasing a dose. To talk to their  doctor if they are unsure about whether the child is experiencing any side effect.
  • To avoid exposing the patient to hot or very warm weather to prevent overheating and the possibility of heat  stroke. To check with the child’s doctor during hot weather to see if the dose of Sialanar should be reduced.
  • To ensure adequate daily dental hygiene and regular dental health checks to reduce the risk of dental caries.
  • If the child seems unwell check the child’s pulse rate and report very slow or very fast heart rate.
  • To look for changes in the general wellbeing or behaviour since the child cannot always express how they feel  and tell the treating healthcare professional.

Additional points to emphasise:

  • To report any side effects, including those not listed.
  • To seek urgent medical advice immediately if the child is given too much Sialanar, even if the child seems well.
  • To tell the child’s doctor if the child is taking, has recently taken or might take any other medicines.To consult  with the prescribing doctor at no longer than 3 monthly intervals to ensure that Sialanar is still an appropriate  treatment for the child.
  • To read the Patient Information Leaflet.

For more detailed information on Sialanar read the Summary of Product Characteristics.
Marketing Authorisation Holder: Proveca Ltd, Daresbury Innovation Centre, Keckwick Lane, Daresbury, Halton, Cheshire, WA4 4FS. United Kingdom. medinfo@proveca.co.uk

This information was last reviewed in September 2016.