OXYBUTYNIN HYDROCHLORIDE

5mg or 5mg given two or three times daily, although this may be increased up to a maximum of 5mg four times daily if required to obtain a clinical response, providing that the side effects are tolerated. It is usually wise to institute treatment slowly to minimise the anticholinergic side effects especially that of a dry mouth.

5mg or 5mg twice daily is likely to be adequate for the elderly (over 80 years) since the elimination time is doubled as compared to healthy young volunteers. In the elderly peak plasma concentrations have also been shown to be greater than in healthy young volunteers.

5mg to 5mg twice daily should be given initially and this can be increased up to 5mg three times daily to obtain a clinical response. In cases of nocturnal enuresis alone, the usual dose is 5mg two or three times daily with the last dose given before bedtime.

Children under 5 years of age:

The safety and efficacy of the tablets have been demonstrated for children 5 years of age and older. There is insufficient clinical data for children under the age of 5 years so that it is not recommended for this age group. Method of administration The tablets are for oral administration.

The tablets should be swallowed with plenty of water or other fluid, to ensure passage through the oesophagus. Following initial control, a reduced maintenance dose may be introduced.

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 • Immune system disorders Not known: hypersensitivity • 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 • Eye disorders Common: dry eyes Not known: Angle closure glaucoma, mydriasis, ocular hypertension, vision blurred • Cardiac disorders Common: palpitation Not known: tachycardia, arrhythmia • Vascular disorders Common: flushing • Gastro-intestinal disorders Very Common: constipation, nausea, dry mouth Common: diarrhea, 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) • Skin and subcutaneous tissue disorders Very common: dry skin Not known: angioedema, rash, urticaria, hypohidrosis • Renal and urinary disorders Common: urinary retention Injury poisoning and procedural complications Not known: heat stroke Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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4. Special Warnings and Special Precautions for Use Oxybutynin should be used with caution in the frail elderly and children who may be more sensitive to the effects of the product and in patients with autonomic neuropathy (such as those with Parkinson’s disease), 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. 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.

1 • Patients with bladder outflow obstruction where urinary retention may be precipitated • Gastro-intestinal obstructive disorders, intestinal atony or paralytic ileus • Toxic megacolon • Severe ulcerative colitis • Myasthenia gravis • Narrow-angle glaucoma or shallow anterior chamber