Glycopyrronium Bromide Oral Solution Abbreviated Prescribing Information

Abbreviated Prescribing Information: Glycopyrronium Bromide 1mg/5ml oral solution. Consult Summary of Product Characteristics before prescribing. Presentation: A clear colourless to straw-yellow solution containing 1 mg of glycopyrronium bromide per 5ml. Therapeutic Indications: Symptomatic treatment of severe sialorrhoea in children and adolescents aged 3 years and older with chronic neurological disorders. Posology and Method of Administration: Glycopyrronium bromide oral solution is advised for short-term intermittent use due to limited long-term safety data. Dosage is determined by the child’s weight, starting at 0.02 mg/kg three times daily with gradual increases every 5–7 days based on response and side effects. The maximum recommended dose is 0.1 mg/kg three times daily, not exceeding 1.5–3 mg per dose depending on weight. During the four-week titration period, dose increases should be carefully monitored for tolerability, especially in younger children who may be more sensitive to adverse effects. After titration, sialorrhoea should be reviewed with the caregiver at least every three months to evaluate efficacy and adjust dosing as needed. If continuous treatment is needed or the treatment is repeated intermittently, benefits and risks should be carefully considered. Paediatric Population: Not recommended for use in children younger than 3 years. It is indicated for the paediatric population only. Elderly Population: Glycopyrronium Bromide should not be used in patients over the age of 65 years. Hepatic Impairment: Clinical studies have not been conducted in patients with hepatic impairment. Hepatic impairment is not thought to result in a clinically relevant increase in systemic exposure. Renal Impairment: Elimination of glycopyrrolate is severely impaired in patients with renal failure. Glycopyrronium is contraindicated in those with severe renal failure. For patients with Mild to moderate renal impairment (eGFR <90 – ≥30 ml/min/1.73m2) doses should be reduced by 30%. Other licensed Glycopyrronium products are not all interchangeable on a milligram-for-milligram basis due to differences in bioavailability; refer to the approved posology of the product if changing between products. Contra-indications: Hypersensitivity to the active substance or to any of the excipients, pregnancy and breast-feeding, glaucoma, urinary retention, severe renal impairment, history of intestinal obstruction, ulcerative colitis paralytic ileus, pyloric stenosis and myasthenia gravis, concomitant treatment with potassium chloride solid oral dose products and anticholinergic medicines. Special Warnings and Precautions for use: Anticholinergic effects may be dose dependent and difficult to assess in a disabled child. Monitoring is required. Treatment should be stopped in the event of constipation, urinary retention, pneumonia, allergic reaction, pyrexia, very hot weather, changes in behaviour. The prescriber should evaluate and decide if treatment should continue at a lower dose. Safety data are not available beyond 24 weeks treatment duration. Total treatment duration should be kept as short as possible. Glycopyrronium should not be given to children with mild to moderate sialorrhoea, should be used with caution in acute myocardial infarction, hypertension, coronary artery disease, cardiac arrhythmias and conditions characterised by tachycardia. Very fast or very slow heart rate should be reported to the prescriber. Glycopyrronium should be used with caution in patients with gastro-oesophageal reflux disease, pre-existing constipation and diarrhoea. It is important that patients receive adequate daily dental hygiene and regular dental health checks. Glycopyrronium can cause thickening of secretions, which may increase the risk of respiratory infection and pneumonia. Glycopyrronium should be discontinued if pneumonia is present. Increased central nervous system effects have been reported. Behavioural changes should be monitored. Caution should be exercised in children with compromised blood brain barrier. The effects of Glycopyrronium on the reproductive system have not been investigated. Whilst clinical studies do not report any short or long-term effect of Glycopyrronium on neurodevelopment or growth, no studies have been conducted to specifically address these issues. Any warning from the MC, CHM CSM or MHRA: No. Black Triangle notice: Not applicable. A list of very common, common and potentially serious adverse reactions is presented below: Very common: irritability, flushing, nasal congestion, reduced bronchial secretions, dry mouth, constipation, diarrhoea, vomiting, urinary retention., Common: upper respiratory tract infection, pneumonia, urinary tract infection, agitation, drowsiness, epistaxis, rash, pyrexia. Common adverse events include: angle-closure glaucoma, transient bradycardia, oesophageal candidiasis, pseudo-obstruction, dehydration, angioedema, and allergic reaction. Refer to the SmPC for full details of other adverse reactions. Pack Size and NHS Price: 150ml – £91.00. Legal Category: POM. Marketing Authorisation Number: PL 00427/0252 Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: Aug- 2025