What is Sialanar - Glycopyrronium bromide and what is it used for?
Sialanar is a medicine for the treatment of severe drooling (excessive saliva secretion) in children and adolescents (3 years of age and older) with neurological conditions such as cerebral palsy, epilepsy and neurodegenerative diseases. Contains the active ingredient glycopyrronium bromide.
How is Sialanar - Glycopyrronium bromide used?
Sialanar is available as a solution to be taken orally 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 must be prescribed by a doctor experienced in treating children with neurological conditions and can only be obtained with a prescription.
How does Sialanar - Glycopyrronium bromide work?
The active substance in Sialanar, glycopyrronium bromide, blocks receptors found in the salivary glands called muscarinic receptors. These receptors trigger saliva production when activated by the nerves of the brain. By blocking the receptors, the medicine is supposed to help reduce the amount of saliva produced by the glands and therefore reduce drooling.
What benefit has Sialanar - Glycopyrronium bromide shown during the studies?
Based on two published studies, glycopyrronium bromide is effective in reducing drooling in children and adolescents with neurological conditions, using a standard rating scale known as mTDS (where a score of 1 means no sialorrhea and a score of 9 means profuse sialorrhea. ).
In one of the studies, involving 38 children and adolescents with severe drooling, a decrease in score of 3 points or more was observed after 8 weeks in approximately 74% of subjects treated with glycopyrronium bromide, compared with 18% of those treated with glycopyrronium bromide. treated with placebo (a dummy treatment).
The second study involved 27 children and adolescents with severe drooling who took glycopyrronium bromide or placebo for 8 weeks and whose treatment was subsequently reversed for another 8 weeks. This study focused on final mean scores for sialorrhea after 8 weeks of treatment, equal to 1.9 for patients treated with glycopyrronium bromide and 6.3 for patients treated with placebo.
What are the risks associated with Sialanar - Glycopyrronium bromide?
The most common side effects with Sialanar (which may affect more than 1 in 10 patients) are irritability, flushing, stuffy nose, reduced secretions in the airways, dry mouth, constipation, diarrhea, vomiting and inability to completely empty the bladder. (urinary retention). For the full list of side effects reported with Sialanar, see the package leaflet.
Sialanar must not be used in patients with glaucoma (an eye disease), urinary retention, severe kidney dysfunction or with a history of certain bowel conditions or myasthenia gravis (a condition affecting the muscles). It must also not be used in patients pregnant or taking potassium chloride tablets or capsules or medicines that have an anticholinergic effect. For the full list of restrictions for Sialanar, see the package leaflet.
Why has Sialanar - Glycopyrronium Bromide been approved?
The use of glycopyrronium bromide is well established in the EU as a treatment for drooling and published studies show that it is effective in the treatment of severe sialorrhea in children and adolescents with neurological conditions that can affect their quality of life. Regarding the risks, side effects occurring with glycopyrronium bromide can be managed through adequate patient monitoring and dose adjustment.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that Sialanar's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Sialanar - Glycopyrronium bromide?
To help doctors and their caregivers use the medicine as safely as possible, the company that markets Sialanar will provide them with material containing information on how to use the medicine and manage side effects correctly.
The recommendations and precautions to be observed by healthcare professionals and patients for Sialanar to be used safely and effectively have also been reported in the summary of product characteristics and package leaflet.
More information about Sialanar - Glycopyrronium bromide
For the full version of Sialanar's EPAR, please consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Sialanar therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The information on Sialanar - Glycopyrronium bromide published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
