DITROPAN

Posology The dosage should be determined individually. Adults The usual dose is 5 mg two or three times a day. This may be increased to a maximum of 5 mg four times a day (maximum dose 20 mg oxybutynin hydrochloride per day) to obtain a clinical response provided that the side effects are tolerated.

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

Paediatric population Children (under 5 years of age) Ditropan is not recommended in children under 5 years of age due to the absence of data. 5 mg twice a day. This dose may be increased to 5 mg 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 increased to 5 mg 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. Method of administration For oral use. The tablets taste unpleasant and should therefore be swallowed with a glass of water.

Like all medicines, oxybutynin can cause undesirable effects, although not everybody gets them. The frequency of possible undesirable effects listed below are currently defined as: 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).

ADVERSE REACTIONS REPORTED System Organ Class Frequency Adverse Reaction (MedDRA Terms) Infections and Infestations Not known urinary tract infection Immune System Not known hypersensitivity ADVERSE REACTIONS REPORTED System Organ Class Frequency Adverse Reaction (MedDRA Terms) Disorders Common confusional state Psychiatric Disorders Not known agitation, anxiety, cognitive disorders in elderly, hallucinations, nightmares, paranoia, symptoms of depression, dependence to oxybutynin (in patients with history of drug or substance abuse) Very common dizziness, headache, somnolence Nervous System Disorders Not known cognitive disorders, convulsions, drowsiness, disorientation Very common vision blurred Common dry eyes Eye Disorders Not known angle closure glaucoma, increased intraocular pressure, mydriasis Common palpitation Cardiac Disorders Not known arrhythmia, tachycardia Vascular Disorders Common flushing (which may be more marked in children) Respiratory, thoracic, and mediastinal disorders Not known epistaxis Very common constipation, dry mouth, nausea Common diarrhoea, vomiting Uncommon abdominal discomfort, anorexia, decreased appetite, dysphagia Gastrointestinal Disorders Not known gastroesophageal reflux, pseudo- obstruction in patients at risk (elderly or patients with constipation and treated with other ADVERSE REACTIONS REPORTED System Organ Class Frequency Adverse Reaction (MedDRA Terms) drugs that decrease intestinal motility) Very common dry skinSkin and Subcutaneous Tissue Disorders Not known angioedema, hypohidrosis, rash, urticaria, photosensitivity Musculoskeletal and connective tissue disorders Not known Muscle disorders manifested as muscle weakness, myalgia and/ or muscle spasms Common urinary retentionRenal and Urinary Disorders Not known difficulty in micturition 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.

− Ditropan should be used with caution in patients with Parkinson’s disease who are at greater risk of occurrence of adverse reactions to the product and in patients with autonomic neuropathy (such as those with Parkinson’s disease), severe gastro-intestinal motility disorders, hepatic, or renal impairment.

− Anticholinergic medicinal products may decrease gastrointestinal motility and should be used with caution in patients with gastrointestinal obstructive disorders, intestinal atony, and ulcerative colitis. − Ditropan may aggravate cognitive disorders, symptoms of prostatic hypertrophy and tachycardia (thus be cautious in case of hyperthyroidism, congestive heart failure, cardiac arrhythmia, coronary heart disease, hypertension).

− Anticholinergic CNS effects (such as hallucinations, agitation, confusion, somnolence) have been reported. Monitoring recommended, particularly in first few months after initiating therapy or increasing the dose. If anticholinergic CNS effects develop, termination of treatment or dose reduction may be considered.

− Since Ditropan 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. − Ditropan 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 Ditropan is used in high environmental temperatures, this can cause heat prostration due to decreased sweating. Elderly Anticholinergic medicinal products should be used with caution in elderly patients due to the risk of cognitive impairment.

They also have a higher risk of occurrence of adverse reactions to the product. Paediatric population The use of Ditropan in children under 5 years of age is not recommended. It has not been established whether Ditropan can be safely used in this age group.

1 − Myasthenia gravis − Narrow-angle glaucoma or shallow anterior chamber − Gastrointestinal obstructive disorders including paralytic ileus, intestinal atony − Toxic megacolon − Severe ulcerative colitis − Bladder outflow obstruction where urinary retention may be precipitated