OXYBUTYNIN HYDROCHLORIDE

Dosage and administration:

Adults: The usual dose is 5 mg (10 ml) two or three times a day. This may be increased to a maximum of 5 mg (10 ml) four times a day to obtain a clinical response provided that the side effects are tolerated.

Elderly (including frail elderly):

The elimination half-life is increased in the elderly. 5 mg (5 ml) twice a day, particularly if the patient is frail, is likely to be adequate. This dose may be titrated upwards to 5 mg (10 ml) two times a day to obtain a clinical response provided the side effects are well tolerated.

5 mg (5 ml) twice a day. This dose may be titrated upwards to 5 mg (10 ml) two or three times a day to obtain a clinical response provided the side effects are well tolerated. 5 mg (5 ml) twice a day. This dose may be titrated upwards to 5mg (10 ml) 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.

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 Disorders Not known Hypersensitivity Common Confusional statePsychiatric 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, somnolenceNervous 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 Not known Arrhythmia, tachycardiaCardiac Disorders Common Palpitation Vascular Disorders Common Flushing (which may be more marked in children) Respiratory, Thoracic, and Mediastinal Disorders Not known Epistaxis ADVERSE REACTIONS REPORTED System Organ Class Frequency Adverse Reaction (MedDRA Terms) 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 drugs that decrease intestinal motility) Very common Dry skin Skin 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.

3). • Gastrointestinal disorders: Anticholinergic medicinal products may decrease gastrointestinalmotility 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), cognitivedisorders and symptoms of prostatic hypertrophy.

g. hallucinations, agitation, confusion, somnolence) have been reported; monitoring recommended especially in first few months after initiating therapyor 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 aphysician 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, parodontosisor 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 heatprostration 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 oxybutynin in children under 5 years of age is not recommended; it has not beenestablished whether oxybutynin can be safely used in this age group.

There is limited evidence supporting the use of Oxybutynin in children withmonosymptomatic nocturnal enuresis (not related to detrusor overactivity). In children over 5 years of age, Oxybutynin hydrochloride should be used with caution as they may be more sensitive to the effects of the product, particularly the CNS and psychiatricadverse reactions.

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. Patients with severe ulcerative colitis.

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