Prescribing Information

Consult the Summary of Product Characteristics (SmPC) before prescribing.

Product name: Rybrila 160 micrograms/ml Oral Solution

Composition: Each ml oral solution contains 200 micrograms of glycopyrronium bromide equivalent to 160 micrograms of glycopyrronium

Legal category: Prescription Only Medicine

Indications: For use in children and adolescents aged 3 years and older with chronic neurological disorders as symptomatic treatment of severe sialorrhoea (chronic pathological drooling).

Dosage and administration: High fat foods reduce oral bioavailability. Hence, take Rybrila one hour before or two hours after meals. Dose should be adjusted to achieve optimal symptomatic control with minimal adverse effects. For oral use and use via nasogastric & PEG feeding tubes. Dosing is based on the weight of the child. Using the graduated syringe provided, initiate dosing at 16 micrograms/kg three times daily and titrate in increments of 16 micrograms/kg every 5-7 days based on therapeutic response and adverse reactions. The maximum recommended dosage is 80 micrograms/kg body weight glycopyrronium or 15 ml three times daily, whichever is less. Please refer to dosing table (Table 1) in full Summary of Product Characteristics. Product is not recommended in children younger than 3 years.

Contraindications: Hypersensitivity to glycopyrronium bromide or excipients. Angle-closure glaucoma; myasthenia gravis; pyloric stenosis; paralytic ileus; intestinal obstruction; urinary retention; severe renal impairment (eGFR < 30 ml/min/1.73 m²); pregnancy & breastfeeding; potassium chloride solid oral products; other anticholinergic drugs.

Warnings and precautions: Should not be used in patients over the age of 65. Use with caution in patients with gastro-oesophageal reflux disease; ulcerative colitis; pre-existing constipation; acute myocardial infarction; hypertension; tachycardia (including hyperthyroidism; cardiac insufficiency, cardiac surgery); coronary artery disease; cardiac arrhythmias, inhalation anaesthesia. Diarrhoea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful. Glycopyrronium can inhibit sweating, patients with increased temperature should be observed closely. In high environmental temperature, heat prostration can occur with use of glycopyrronium. Avoid repeated or large doses of glycopyrronium in patients with uraemia. Patients with fructose intolerance should not take this medicine due to presence of sorbitol. No safety data beyond 24 weeks. Treatment should be kept as short as possible. Patients should receive adequate daily dental hygiene and regular dental health checks. Caution should be exercised in children with compromised blood brain barrier e.g.: intraventricular shunt, brain tumour, encephalitis.

Drug interactions: May have additive anticholinergic effects: tricyclic antidepressants; sedating antihistamines, monoamine oxidase inhibitors; neuroleptics / antipsychotics (phenothiazines, clozapine, haloperidol) and dose reduction may be needed. Combinations with corticosteroids may result in increased intraocular pressure. Botulinum toxin. Opioids such as pethidine and codeine. Domperidone. Metoclopramide. Topiramate. Inhaled anaesthetics.

Adverse effects:

Very Common: dry mouth, reduced bronchial secretions, constipation, diarrhoea, vomiting, nasal congestion, behavioural changes, flushing;

Common: pneumonia, pyrexia, urinary retention;

Uncommon: hives, allergic reaction, seizure (worsening), dizziness, insomnia, pseudo-obstruction, gastrointestinal mobility disorder, eosophageal candidiasis, breath odour, nystagmus, urinary urgency, dehydration, thirst. Consult Summary of Product Characteristics for all adverse effects.

Marketing Authorization Holder: Clinigen Healthcare B.V. Schiphol Boulevard 359 WTC Schiphol Airport D Tower 11th floor 1118BJ SchipholNiederlande

Job number: UK-CPL-061-751

Date of preparation: November 2024