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2 mg/5 ml

(400 mcg/ml)
strength
The first non-branded 2 mg/5 ml

glycopyrronium bromide oral solution

An opportunity for adolescents to continue their treatment into adulthood

For the symptomatic treatment of severe sialorrhoea (chronic
pathological drooling) due to chronic neurological disorders of
childhood-onset in patients aged 3 years and older.
1

Colonis Glycopyrronium Bromide 2 mg/5 ml Oral Solution
gives patients the opportunity to continue their stable dose
into adulthood. 1

• The 2 mg/5 ml solution is available in 60 ml and 250 ml bottles.

• Sugar-free, strawberry flavour – strawberry is the most popular

flavour with children. 2
• A formulation suited for children with swallowing issues. 3

• Licensed for use with nasogastric and/or PEG tubes. 1

PIP Codes: 128-0841 (60 ml), 128-0833 (250 ml)

Colonis Glycopyrronium Bromide Oral Solution 2 mg/5 ml is now
available to order via Phoenix

PRESCRIBING INFORMATION inhaled anaesthetics. May delay absorption of other medication. Concurrent use with slow-
Please consult the Summary of Product Characteristics (SmPC) before prescribing. dissolving tablets of digoxin, atenolol or metformin may result in increased serum levels of these
medicines. Use with parasympathomimetics may antagonise the effect.
Product name: Glycopyrronium Bromide 2 mg/5 ml Oral Solution Adverse effects:
Composition: Each 5 ml contains 2 mg of glycopyrronium bromide Serious: Allergic reaction, seizure (worsening), transient bradycardia, angle-closure glaucoma,
Indications: Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) due to urinary retention (common), pneumonia (common), pyrexia (common), behavioural
chronic neurological disorders of childhood-onset in patients aged 3 years and older. changes (very common)
Dosage and administration: Dosing is based on the weight of the child. Using the graduated Very common: Dry mouth, constipation, diarrhoea, vomiting, flushing, nasal congestion, reduced
syringe provided, initiate dosing at 0.02 mg/kg three times daily and titrate in increments of bronchial secretions. Consult the SmPC for further details and for other adverse reactions.
0.02 mg/kg every 5-7 days. Adjust dose to achieve optimal symptomatic control with minimal NHS price: 60 ml: £76.80, 250 ml: £320
adverse effects. The maximum recommended dosage is 0.1 mg/kg three times daily not
exceeding 1.5-3 mg per dose based on weight. Refer to dosing table (Table 1) in Summary of Legal category: Prescription Only Medicine
Product Characteristics. Dose should be given one hour before or two hours after meals. For oral Marketing Authorisation Holder: Colonis Pharma Limited, 25 Bedford Square, Bloomsbury,
use and use via nasogastric & PEG feeding tubes. London, WC1B 3HH, United Kingdom
Contraindications: Hypersensitivity to glycopyrronium bromide or excipients; angle-closure MA number: PL 41344/0071
glaucoma; myasthenia gravis; pyloric stenosis; paralytic ileus; prostatic enlargement; urinary Job number: GB-CPL-066-001
2
retention; severe renal impairment (eGFR < 30 ml/min/1.73 m , including those with end-stage
renal disease requiring dialysis); intestinal obstruction; pregnancy & breastfeeding; potassium Date of preparation: December 2024
chloride solid oral dose products; other anticholinergic drugs. Contraindicated during pregnancy
and whilst breastfeeding. Adverse events should be reported. Reporting forms and information can be found
Warnings and precautions: Not recommended in children under 3 years and should not be used at: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or
in children with mild to moderate sialorrhoea or in patients over 65 years. Use with caution in Apple App Store. Adverse events should also be reported to Colonis Pharma Limited via
children with compromised blood brain barrier. Reduced dose should be considered for patients Clinigen E-mail: drugsafety@clinigengroup.com
with renal failure. Use with caution in gastro-oesophageal reflux disease, ulcerative colitis, Fax number: +44 (0) 1932 824284
pre-existing constipation, acute myocardial infarction, hypertension, conditions characterised
by tachycardia (including hyperthyroidism, cardiac insufficiency, cardiac surgery), coronary
artery disease, cardiac arrhythmias, patients receiving inhalation anaesthesia. Diarrhoea may Abbreviation
be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy PEG, percutaneous endoscopic gastronomy.
or colostomy, and treatment with this drug would be inappropriate and possibly harmful. As
glycopyrronium bromide inhibits sweating, patients with increased temperature should be References
observed closely. In high environmental temperature, heat prostration can occur. Avoid repeated 1. Colonis Pharma Ltd. Glycopyrronium Bromide 2 mg/5 ml Oral Solution Summary of Product
or large doses in patients with uraemia. Patients with fructose intolerance should not take this Characteristics. Available from: https://www.medicines.org.uk/emc/.
medicine due to presence of sorbitol. The product contains sodium propyl parahydroxybenzoate 2. Generation R. What flavour would children choose for their medicines? Available from: https://
(E217) and sodium methyl parahydroxybenzoate (E219) which may cause allergic reactions generationr.org.uk/what-flavour-would-children-choose-for-their-medicines/
(possibly delayed). Treatment should be evaluated in the event of constipation, overheating, [Accessed January 2025].
urinary retention, pneumonia, allergic reaction, pyrexia, very hot weather, changes in behaviour. 3. Batchelor HK and Mariott JF. Formulations for children; problems and solutions. Br J Pharmacol.
Safety data beyond 24 weeks are not available. Treatment should be kept as short as possible. 2015;79(3):405–418.
May produce drowsiness or blurred vision, thus patients should not operate machinery. © Colonis Pharma Limited 2025
Drug interactions: Combinations with drugs with antimuscarinic effects (e.g. amantadine,
tricyclic antidepressants, antihistamines, clozapine; disopyramide; MAOIs, nefopam; memantine, Registered in England & Wales No. 05486832. For more information please view our Privacy
phenothiazines) may add to adverse effects and can also lead to confusion in the elderly. Use Policy. VAT Registration No. 862418028. Registered office: Colonis Pharma Ltd, 25 Bedford Square,
with corticosteroids may result in increased intraocular pressure. There are specific interactions Bloomsbury, London, WC1B 3HH.
with domperidone, metoclopramide, levodopa, haloperidol; nitrates; topiramate, zonisamide; January 2025 | GB-CPL-066-002
07/02/2025 11:51:00
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