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Sialanar (glycopyrronium) Oral Solution – how to manage common side effects

The side effects associated with Sialanar (an anticholinergic drug) may be dose dependent and difficult to assess in a disabled child. Your child’s doctor will talk to you about common side effects that may occur and how to manage them.

It is important to make sure an accurate dose is given each time, in order to prevent harmful effects of Sialanar seen with dosing errors or overdose.

Important Information on the administration of Sialanar

Always give Sialanar exactly as the doctor has told you. You should not increase the dose without the doctor’s permission. Check with your doctor if you are not sure.
Give Sialanar at least one hour before or two hours after meals. If the child’s specific needs determine that co-administration with food is required, it is important to give Sialanar at consistent times in relation to food intake. Do not give with high fat foods.
You must measure and check the dose of Sialanar using the special measuring device (oral syringe) provided. Always double check if the correct volume of Sialanar is pulled into the syringe. Instructions on how to use the syringe are provided in the Patient Information Leaflet.
The administration table at the end of this card should be completed by the prescribing physician initially and at each dose change. Its purpose is to remind the caregiver of the correct dose to be given to the child.

How to manage important side effects

If any of the following side effects occur, stop giving the medicine to the child and seek urgent medical advice;

Difficulty in passing stools (constipation)
Difficulty in passing urine or unable to completely empty the bladder (urinary retention)
Severe chest infection (pneumonia)
Allergic reaction (rash, itching, red raised itchy rash (hives), difficulty breathing or swallowing, dizziness)
Side effects can sometimes be difficult to detect in some patients with neurologic problems who cannot adequately express how they feel. If you think that a troublesome side effect is occurring after increasing the dose, decrease the dose to the previous one and contact the child’s doctor.

Avoid exposing the child to hot or very warm weather to avoid overheating and the possibility of heat stroke. Check with the child’s doctor during hot weather or if the child has a fever, to see if the dose of Sialanar should be reduced.

Since reduced salivation can increase the risk of dental disease, daily dental hygiene and regular dental health checks should be performed.

Check the child’s pulse at regular intervals. Check with the child’s doctor if the heart beat is very slow or very rapid.

You should look for any changes in the child’s well-being or behaviour and tell the child’s doctor.

Additional information

 Seek urgent medical advice immediately if the child is given too much Sialanar, even if the child seems well.

Tell the child’s doctor if your child is taking, has recently taken or might take any other medicines. 

Check with the child’s doctor at least every 3 months to make sure Sialanar is still right for the child.

Further information about taking Sialanar can be found in the Patient Information Leaflet and can be obtained from your child’s doctor.

Please refer to the dose administration table below for the correct dose to be given to your child.

Sialanar Dosing Table

For more detailed information on Sialanar read the Patient Information Leaflet.

Marketing Authorisation Holder: Proveca Pharma Limited, Marine House, Clanwilliam Place, Dublin 2, Ireland

This information was last revised May 2017.