What is Sialanar?

• Sialanar, or glycopyrronium bromide, is used for the symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.

How is Sialanar used?

• Sialanar is available as a solution to be taken by mouth three times a day, one hour before or two hours after meals. The starting dose depends on the patient’s body weight. The dose is then adjusted according to how the patient responds to the medicine and its side effects.
• Sialanar should be prescribed by a doctor with experience in treating children with nervous system conditions and it can only be obtained with a prescription.

How does Sialanar work?

• The active substance in Sialanar, glycopyrronium bromide, blocks receptors in the salivary glands known as muscarinic receptors. These receptors trigger the production of saliva when activated by nerves from the brain. By blocking the receptors, the medicine is expected to help reduce the amount of saliva produced by the glands and so reduce drooling.

What benefits of Sialanar have been shown in studies?

• Two published studies showed that glycopyrronium bromide was effective at reducing drooling in children and adolescents with nervous system conditions, using a standard rating scale known as mTDS (where a score of 1 means no drooling and a score of 9 means profuse drooling).
• In one of the studies in 38 children and adolescents with severe drooling, around 74% of those taking glycopyrronium bromide after 8 weeks had their scores reduced by 3 points or more compared with 18% of those taking placebo (a dummy treatment).
• The second study involved 27 children and adolescents with severe drooling who took either glycopyrronium bromide or placebo for 8 weeks and then had their treatment switched for another 8 weeks. This study focused on the average final drooling scores after 8 weeks of treatment, which were 1.9 in patients on glycopyrronium bromide and 6.3 in patients on placebo.

What are the risks associated with Sialanar?

• The most common side effects with Sialanar (which may affect more than 1 in 10 people) are irritability, flushing, blocked nose, reduced secretions in the airways, dry mouth, constipation, diarrhoea, vomiting and inability to completely empty the bladder (urinary retention). For the full list of all side effects reported with Sialanar, see the package leaflet.
• Sialanar must not be used in patients with glaucoma (an eye condition), urinary retention, severe kidney impairment or a history of certain intestinal conditions or myasthenia gravis (a condition affecting muscles). It must also not be used in patients who are pregnant or are taking potassium chloride tablets or capsules or medicines which have anticholinergic effect. For the full list of restrictions with Sialanar, see the package leaflet or talk to your Doctor or pharmacist.

When should the medicine start working?

• The medicine starts to work straight away. However, because the dose is usually gradually increased it may take some time before you see the full effect.

What if my child is sick (vomits)?

If your child is sick:

• less than 30 minutes after having a dose of glycopyrronium, give the same dose again.
• more than 30 minutes after having a dose of glycopyrronium, you do not need to give them another dose. Wait until the next normal dose.

What if I forget to give it?

• Give the next dose when it is due. Do not give a double dose to make up for the forgotten dose.

Are there any possible side-effects?

Side-effects you must do something about:

• If your child has any difficulty with urination (doing a wee) when they feel they need to, take them to your doctor or to hospital straight away.
• Your child’s eyesight may become blurred (fuzzy). If this happens, contact your doctor for advice.

Other side-effects you need to know about

• Your child may get constipation (difficulty doing a poo), and feel sick or be sick.
• They may have a dry mouth. Taking sips of water or sucking on citrus fruits (e.g. oranges) may help.
• They may seem agitated, show changes in mood, have difficulty remembering things, may seem confused and may have hallucinations (seeing things that are not there).

If any of these side-effects become a problem, discuss this with your doctor. They may suggest a lower dose for a short time to help your child’s body get used to the medicine. Do not change the dose without discussing this with your doctor first.

Can other medicines be given at the same time as glycopyrronium bromide?

• You can give your child medicines that contain paracetamol or ibuprofen, unless your doctor has told you not to.
• Glycopyrronium should not be taken with some medicines that you get on prescription. Tell your doctor and pharmacist about any other medicines your child is taking before giving glycopyrronium.
• Check with your doctor or pharmacist before giving any other medicines to your child. This includes herbal or complementary medicines.

Where I should keep this medicine?

• Keep the medicine in a cupboard, away from heat and direct sunlight. It does not need to be kept in the fridge.
• Make sure that children cannot see or reach the medicine.
• Keep the medicine in the container it came in.

References:

https://www.medicines.org.uk/emc/medicine/32715#gref

https://www.medicines.ie/medicines/sialanar-320-micrograms-ml-glycopyrronium-400-micrograms-ml-glycopyrronium-bromide-oral-solution-34451/smpc

https://www.ema.europa.eu/en/medicines/human/EPAR/sialanar

https://www.ema.europa.eu/en/documents/product-information/sialanar-epar-product-information_en.pdf

https://www.nice.org.uk/advice/es5/chapter/Product-overview

https://www.scottishmedicines.org.uk/medicines-advice/glycopyrronium-bromide-sialanar-abbreviatedsubmission-125417/

https://www.scottishmedicines.org.uk/media/1781/glycopyrronium_bromide_sialanar_abbreviated_final_june_2017_for_website.pdf