Indication: Symptomatic treatment of severe sialorrhoea in adolescents and children over three years of age, with chronic neurological disorders. Not recommended for children younger than three years of age. Should be prescribed by physicians experienced in the treatment of neurological disorders. Dosage & Administration: Oral tablets; can be divided into equal doses. Weight-based dosing schedule – initiation: 0.02mg/kg three times daily; modification: titrated in increments of 0.02mg/kg per week depending on therapeutic response and tolerability; maximum: 0.1mg/kg three times daily, not to exceed 1.5–3mg per dose. Other formulations are available for doses which cannot be achieved with tablet format, or for patients unable to swallow tablets. Following dose titration, monitor efficacy/tolerability at least every 3 months. Contraindications: Hypersensitivity to glycopyrronium bromide or any of the excipients. Glaucoma. Urinary retention. Severe renal impairment (estimated glomerular filtration rate [eGFR] <30ml/min/1.73m2, including those with end stage renal disease requiring dialysis). History of intestinal obstruction, ulcerative colitis, paralytic ileus, pyloric stenosis or myasthenia gravis. Pregnancy or breast-feeding. Concomitant treatment with potassium chloride (solid oral dose) or anticholinergics. Precautions and Warnings: Indicated for paediatric use only. Limited data are available on the use of glycopyrronium in adults with pathological drooling; should not be used in patients over 65 years of age. Co-administration with food markedly reduces systemic exposure; administer ≥1 hour prior or ≥2 hours following meals, or at consistent times with respect to food intake; avoid high fat food. If co-administration with food is required, dosing should be consistently performed during food intake. 30% dose reduction required for patients with mild to moderate renal impairment (eGFR <90 – ≥30ml/min/1.73m2). Hepatic impairment is not thought to result in clinically relevant increases in systemic exposure, however, clinical studies have not been conducted in this setting. Anticholinergic effects may be dose dependent and difficult to assess in a disabled child; advise carer to stop treatment and seek advice in the event of: constipation, urinary retention, pneumonia, allergic reaction, pyrexia, very hot weather, changes in behaviour – following evaluation, prescriber to decide if dose reduction or discontinuation are appropriate (discontinue if pneumonia is present). Published safety data for long-term use (>24 weeks) are not available; recommended for short-term intermittent use, total treatment duration should be kept as short as possible. Benefit-risk should be carefully considered, and patients closely monitored, in cases of continuous or repeated intermittent use. Should not be administered to children with mild to moderate sialorrhoea. Use with caution in patients with gastro-oesophageal reflux disease, pre-existing constipation, diarrhoea, compromised blood brain barrier (intraventicular shunt, brain tumour, encephalitis), acute myocardial infarction, hypertension, coronary artery disease, cardiac arrhythmias and conditions characterised by tachycardia (including thyrotoxicosis, cardiac insufficiency, cardiac surgery); advise carer to measure pulse rate if the child seems unwell, and to report occurrences of very fast or very slow heart rate. Patients should receive adequate daily dental hygiene and regular dental health checks. Behavioural changes should be monitored. Not suitable for patients with rare hereditary problems of galactose intolerance, the total lactase deficiency, glucose-galactose malabsorption or fructose intolerance. No short or long-term effects on neurodevelopment or growth have been reported, however, no studies have been conducted to specifically address these issues, or effects on the reproductive system. Interactions: No interaction studies have been performed. Cautious consideration (and dose adjustment, where appropriate) required prior to concomitant use of: antispasmodics, topiramate, sedating antihistamines, neuroleptics/antipsychotics, skeletal muscle relaxants, tricyclic antidepressants and monoamine oxidase inhibitors, opioids, corticosteroids. Medicinal products with anticholinergic properties may cause cumulative parasympatholytic effects, including: dry mouth, urinary retention, constipation and confusion, and an increased risk of anticholinergic intoxication syndrome. Fertility, Pregnancy and Lactation: No data are available on the effects of glycopyrronium bromide tablets on male or female fertility; murine (rat) data indicate decreased rates of conception and survival at weaning. Insufficient data available in the public domain to adequately assess effects on the reproductive system in young adults. Contraindicated during pregnancy (no data available in this setting) and breast-feeding (safety in breast-feeding has not been established); women of child-bearing potential should consider effective contraception, where appropriate. Effects on ability to drive and use machinery: Moderate influence – glycopyrronium may cause blurred vision, dizziness and other effects that may impair a patient’s ability to perform skilled tasks (such as driving, riding a bicycle or using machinery); these undesirable effects are increased with increasing dose. Adverse Events: Adverse reactions are more common with higher doses and prolonged use. The most common (incidence ≥15%) anticholinergic adverse reactions reported during placebo-controlled studies were gastrointestinal events: dry mouth, constipation, diarrhoea and vomiting; other anticholinergic-related events occurring in ≥15% of patients included: urinary retention, flushing, and nasal congestion. Very common (≥1/10): irritability, flushing, nasal congestion, reduced bronchial secretions, dry mouth, constipation, diarrhoea, vomiting, urinary retention. Common (≥1/100 to <1/10): upper respiratory tract infection, pneumonia, urinary tract infection, agitation, drowsiness, epistaxis, rash, pyrexia. Overdose: Overdose can result in anticholinergic syndrome; clinical manifestations are caused by CNS effects and/or peripheral nervous system effects. Patients/caregivers should be counselled to ensure accurate dosing to prevent anticholinergic reactions due to overdose or dosing errors. Please refer to relevant SmPC for full information on adverse events (including those of uncommon, rare, very rare or unknown frequency), overdose, and guidance on the management of selected adverse reactions and overdose. Legal Category: POM. Price: 30 tablets: 1mg £79.00; 2mg £123.00. Marketing Authorisation Number: 1mg PL20117/0094; 2mg PL20117/0095. Marketing Authorisation Holder: Morningside Healthcare Ltd, Unit C, Harcourt Way, Leicester, LE19 1WP, UK. Date reviewed: November 2024. Version number 10103111712 v 2.0
