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Glycopyrronium Bromide Oral Solution Abbreviated Prescribing Information

Abbreviated Prescribing Information: Glycopyrronium Bromide 1mg/5ml oral solution. 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: Not recommended for use in children younger than 3 years. It is indicated for the paediatric population only. 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. 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. 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. Total treatment duration should be kept as short as possible. If continuous treatment is needed or the treatment is repeated intermittently benefits and risks should be carefully considered. 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. Black Triangle notice: Not applicable. Legal Category: POM. A list of very common and common reactions are presented below and refer the SmPC for other reactions: 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, and pyrexia. Pack Size and NHS Price: 150ml – £91.00. 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: December 2022

Adverse Drug Events

Information about adverse event reporting can be found at www.mhra.gov.uk/yellowcard
Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400