OXYBUTYNIN HYDROCHLORIDE

Posology Adults:

The usual dose is 5mg two or three times a day. This may be increased up to a maximum of 5mg four times a day to obtain a clinical response, provided 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.

Elderly (including frail elderly):

The elimination half-life is increased in the elderly. 5mg twice a day, particularly if the patient is frail, is likely to be adequate. This dose may be titrated upwards to 5mg two times a day to obtain a clinical response provided the side effects are well tolerated.

5mg twice a day. This dose may be titrated upwards to 5mg two or three times a day to obtain a clinical response provided the side effects are well tolerated. 5 mg twice a day. This dose may be titrated upwards to 5mg two or three times a day to obtain a clinical response provided the side effects are tolerated.

The last dose should be given before bedtime.

Children under 5 years of age:

Not recommended. Method of administration The tablets are for oral administration. The tablets should be swallowed with plenty of water or other fluid.

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 • Gastrointestinal 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.

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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. Oxybutynin may aggravate tachycardia (and thus 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 the 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