Oxytrol Portal

MINIMUM PRODUCT INFORMATION OXYTROL® (oxybutynin) 3.9 mg/day Transdermal Delivery System® INDICATIONS: Overactive bladder with symptoms of urinary frequency, urgency and/or incontinence. CONTRAINDICATIONS: Urinary or gastric retention, uncontrolled narrow-angle glaucoma, severe ulcerative colitis, toxic megacolon, myasthenia gravis. Hypersensitivity to oxybutynin or any components. PRECAUTIONS: Hepatic or renal impairment, autonomic neuropathy, cognitive impairment, Parkinson’s disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, hypertension, prostatic hypertrophy clinically significant bladder outflow obstruction, gastrointestinal obstructive disorders, non-severe ulcerative colitis, intestinal atony, gastro-oesophageal reflux, combined use with medicines that can cause or exacerbate oesophagitis. Assess for other causes of frequent urination before treatment. Counsel patients on risk of anticholinergic effects; heat prostration in a hot environment, somnolence, blurred vision. Caution if driving, operating machinery, consuming alcohol. Pregnancy Category B1. Lactation: excretion unknown. INTERACTIONS: Other anticholinergic agents. ADVERSE EFFECTS: Application site reactions, dry mouth, dysuria, constipation, diarrhoea, abdominal pain, nausea, flatulence, abnormal vision, fatigue, somnolence, headache, flushing, rash, back pain. DOSAGE AND ADMINISTRATION: Apply one patch twice weekly to dry, intact skin on the abdomen, hip, or buttock. Avoid application to the same site within 7 days. PRESENTATION AND STORAGE: Packs of 8, store below 25oC. Do not store outside the sealed pouch. Apply immediately after removal from the protective pouch. Sponsored in Australia by Theramex Australia Pty Ltd, ABN 37 623 186 845, 60 Margaret Street, Sydney, NSW 2000. www.theramex.com.au Based on the PI last updated 19 April 2021. Date of preparation: September 2025. OXYT_AU_EN_13067_v1