OXYBUTYNIN HYDROCHLORIDE

Children under 5 years of age:

Not recommended Children over 5 years of age: Neurogenic bladder disorders: The usual dose is 5mg twice a day. This may be increased to a maximum of 5mg three times a day to obtain a clinical response provided that the side effects are tolerated.

Nocturnal enuresis:

The usual dose is 5mg two or three times a day. The last dose should be given before bedtime. In children the maintenance dose may be achieved by upward titration from an initial dose of 3mg twice daily.

Adults:

The usual dose is 5mg two or three times a day. This may be increased to a maximum dosage of 5mg four times a day (20mg) to obtain a satisfactory clinical response provided that the side effects are tolerated.

Elderly:

The elimination half-life may be increased in some elderly patients, therefore, dosage should be individually titrated commencing at 3mg twice a day. The final dosage will depend on response and tolerance to side-effects. As with other anticholinergic drugs caution should be observed in frail and elderly patients.

Classification of expected frequencies:

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). • Infections and infestations Not known: urinary tract infection • Gastro-intestinal disorders Very common: constipation, nausea, dry mouth Common: diarrhoea, vomiting Uncommon: abdominal discomfort, anorexia, decreased appetite, dysphagia Not known: gastroesophageal reflux disease pseudo-obstruction in patients at risk (elderly or patients with constipation and treated with other medicinal products that decrease intestinal motility) • Psychiatric disorders Common: confusional state Not known: agitation, anxiety, hallucinations, nightmares, paranoia, cognitive disorders in elderly, symptoms of depression, dependence (in patients with history of drug or substance abuse) • Nervous system disorders Very common: dizziness, headache, somnolence Not known: cognitive disorders, convulsions, drowsiness, disorientation • Cardiac disorders Common: palpitation Not known: tachycardia, arrhythmia • Injury, poisoning and procedural complications Not known: heat stroke • Eye disorders Very common: vision blurred Common: dry eyes Not known: Angle closure glaucoma, mydriasis, ocular hypertension, • Renal and urinary disorders Common: urinary retention Not known: difficulty in micturition • Vascular disorders Common: flushing which may be more marked in children • Skin and subcutaneous tissue disorders Very common: dry skin Not known: angioedema, rash, urticaria, hypohidrosis, photosensitivity • Immune system disorders Not known: hypersensitivity.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard

• Oxybutynin should be used with caution in the frail elderly, patients with Parkinson’s disease and children who are at greater risk of occurrence of adverse reactions to the product and in patients with autonomic neuropathy, severe gastro-intestinal motility disorders, hepatic or renal impairment.

• Anticholinergics should be used with caution in elderly patients due to the risk of cognitive impairment. • Gastrointestinal disorders: Anticholinergic medicinal products may decrease gastrointestinal motility and should be used with caution in patients with gastrointestinal obstructive disorders, intestinal atony and ulcerative colitis.

• Oxybutynin may aggravate tachycardia (and thus be cautious in case of hyperthyroidism, congestive heart failure, cardiac arrhythmia, coronary heart disease, hypertension), cognitive disorders and symptoms of prostatic hypertrophy.

g. hallucinations, agitation, confusion, somnolence) have been reported; monitoring recommended especially in first few months after initiating therapy or increasing the dose; consider discontinuing therapy or reducing the dose if anticholinergic CNS effects develop.

• Since oxybutynin can cause narrow-angle glaucoma, patients should be advised to contact a physician immediately if they are aware of a sudden loss of visual acuity or ocular pain. • Oxybutynin may reduce salivary secretions which could result in dental caries, parodontosis or oral candidiasis.

• Anticholinergic medicinal products should be used with caution in patients who have hiatus hernia/gastro-oesophageal reflux and/or who are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis.

• When oxybutynin is used in high environmental temperatures, this can cause heat prostration due to decreased sweating. Paediatric population The use of oxybutynin in children under 5 years of age is not recommended; it has not been established whether oxybutynin can be safely used in this age group.

Hypersensitivity to oxybutynin or any component. Myasthenia gravis. Narrow-angle glaucoma or shallow anterior chamber. Gastrointestinal obstructive disorders including paralytic ileus, intestinal atony. Patients with toxic megacolon. Patinets with severe ulcerative colitis.

Patients with bladder outflow obstruction where urinary retention may be precipitated.