Oxybutynin Abbreviated Prescribing Information

Abbreviated Prescribing Information: Oxybutynin Hydrochloride 2.5mg/5ml and 5mg/5ml Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: A clear colourless to slightly straw-coloured liquid. Each 5ml contains 2.5mg and 5mg oxybutynin hydrochloride, respectively. Therapeutic Indications: Oxybutynin hydrochloride is indicated in children of 5 years of age or older for urinary incontinence and nocturnal enuresis associated with detrusor overactivity, in conjunction with non-drug therapy when other treatment has failed. Posology and Method of Administration: The usual dosage for adults is 5mg twice or three times a day, with the maximum dose being 20mg per day. Elderly patients should take 2.5mg twice a day, especially if frail. In elderly patients, a dose of 2.5 mg twice daily is advised if the patient is frail. If the side effects are well tolerated, a maximum dose of 5 mg twice daily may be given to achieve a clinical response. Paediatric population: Administration to children under 5 years old is not recommended. For treating neurogenic bladder instability and nocturnal enuresis in children aged 5 years or older, dosage ranges from 2.5 mg twice a day to 5 mg two or three times a day is recommended, depending on the patient and clinical response. The last dose should be given before bedtime. Oral administration is the preferred method. Contra-indications: Hypersensitivity to the active substance or to any of the excipients listed, Myasthenia gravis, Narrow-angle glaucoma or shallow anterior chamber, Gastrointestinal obstructive disorders including paralytic ileus, intestinal atony, Patients with toxic megacolon, Patients with severe ulcerative colitis, Patients with bladder outflow obstruction where urinary retention may be precipitated. Special Warnings and Precautions for use: Oxybutynin should be used cautiously in patients with Parkinson’s disease, autonomic neuropathy, severe gastrointestinal disorders, hepatic or renal impairment, gastrointestinal obstructive disorders, intestinal atony, ulcerative colitis, cognitive disorders, prostatic hypertrophy, tachycardia, hyperthyroidism, congestive heart failure, cardiac arrhythmia, coronary heart disease, and hypertension. Anticholinergic CNS effects (e.g., hallucinations, agitation, confusion, and somnolence) have been reported; hence, monitoring is recommended, especially in the first few months after therapy or increasing the dose. Patients should contact a physician if they notice a sudden loss of visual acuity or ocular pain. Oxybutynin may reduce salivary secretions, potentially leading to dental caries, parodontosis, or oral candidiasis. Caution should be exercised in patients who have hiatus hernia/gastro-oesophageal reflux and/or who are concurrently taking medicinal products (such as bisphosphonates), as this can cause or exacerbate oesophagitis. High environmental temperatures can cause heat prostration due to decreased sweating. Any warning from the MC, CHM CSM or MHRA: N/A. Black Triangle notice (if relevant) N/A. Legal Category: POM. A list of very common, common and serious adverse reactions are constipation, nausea, dry mouth, diarrhoea, vomiting, pseudo obstruction in patients at risk, confusional state, cognitive disorders in the elderly, depression, dependence, convulsions, dizziness, headache, somnolence, palpitation, vision blurred, dry eyes, urinary retention, flushing which may be more marked in children, dry skin, photosensitivity, angioedema, hypersensitivity, heat stroke, angle closure glaucoma, muscle disorders, tachycardia, and arrhythmia. Refer to the SmPC for details of other adverse reactions. Pack Size and NHS Price: 150ml –  2.5mg/5ml – £199.75, 5mg/5ml – £217.01.  Marketing Authorisation Number: PL 00427/0265 (2.5mg/5ml) and PL 00427/0266 (5mg/5ml). Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [February-2025].