Kentera (previously Oxybutynin Nicobrand) · 4.3 Contraindications · 1

HOS-093726 · has-adverse-reaction-information · PDF-Seite 4

Summary of the safety profile The most commonly reported adverse drug reactions were application site reactions, occurring in 23.1% of patients. Other commonly occurring adverse drug reactions reported were dry mouth (8.6%), constipation (3.9%), diarrhoea (3.2%), headache (3.0%), dizziness (2.3%) and blurred vision (2.3%). Tabulated list of adverse reactions Adverse reactions from phase 3 and 4 clinical studies are listed below by system organ class and frequency grouping. Frequencies are 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). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Post- marketing adverse reactions not seen in clinical trials are also included. System Organ Class Frequency Adverse reaction (MedDRA) Infections and Common Urinary tract infection infestations Uncommon Upper respiratory tract infection, fungal infection Psychiatric disorders Uncommon Anxiety, confusion, nervousness, agitation, insomnia 4  Rare Panic reaction#, delirium#, hallucinations#, disorientation# Nervous system Common Headache, somnolence disorders Rare Memory impairment#, amnesia#, lethargy#, disturbance in attention# Eye disorders Common Blurred vision Ear and labyrinth Common Dizziness disorders Cardiac disorders Uncommon Palpitations Vascular disorders Uncommon Urticaria, hot flushes Respiratory, thoracic Uncommon Rhinitis and mediastinal disorders Gastrointestinal Common Dry mouth, constipation, diarrhoea, nausea, disorders abdominal pain Uncommon Abdominal discomfort, dyspepsia Musculoskeletal and Uncommon

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HOS-093722 · has-contraindication-information · PDF-Seite 2

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 2 Kentera is contraindicated in patients with urinary retention, severe gastro-intestinal condition, myasthenia gravis or narrow-angle glaucoma and in patients who are at risk for these conditions.

HOS-093721 · has-indication-information · PDF-Seite 2

Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with unstable bladder.

HOS-093724 · has-interaction-information · PDF-Seite 3

The concomitant use of oxybutynin with other anticholinergic medicinal products or with other agents that compete for CYP3A4 enzyme metabolism may increase the frequency or severity of dry mouth, constipation, and drowsiness. 3 Anticholinergic agents may potentially alter the absorption of some concomitantly administered medicinal products due to anticholinergic effects on gastrointestinal motility. As oxybutynin is metabolised by cytochrome P 450 isoenzyme CYP3A4, interactions with medicinal products that inhibit this isoenzyme cannot be ruled out. This should be borne in mind when using azole antifungals (e.g. ketoconazole) or macrolide antibiotics (e.g. erythromycin) concurrently with oxybutynin. The anticholinergic activity of oxybutynin is increased by concurrent use of other anticholinergics or medicinal products with anticholinergic activity, such as amantadine and other anticholinergic antiparkinsonian medicinal products (e.g. biperiden, levodopa), antihistamines, antipsychotics (e.g. phenothiazines, butyrophenones, clozapine), quinidine, tricyclic antidepressants, atropine and related compounds like atropinic antispasmodics, dipyridamole. Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as oxybutynin (see section 4.7). Oxybutynin may antagonize prokinetic therapies.

HOS-093725 · has-pregnancy-information · PDF-Seite 4

Pregnancy There are no adequate data on the use of oxybutynin transdermal patch in pregnant women. Studies in animals have shown minor reproductive toxicity (see section 5.3). Kentera should not be used during pregnancy unless clearly necessary. Breast-feeding When oxybutynin is used during breast-feeding, a small amount is excreted in the mother’s milk. Use of oxybutynin while breast-feeding is therefore not recommended.

HOS-093723 · has-warning-information · PDF-Seite 3

Kentera should be used with caution in patients with hepatic or renal impairment. The use of Kentera in patients with hepatic impairment should be carefully monitored. Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Kentera. If urinary tract infection is present, an appropriate antibacterial therapy should be started. Urinary retention: Anticholinergic products should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. Kentera should be used with caution in elderly patients, who may be more sensitive to the effects of centrally acting anticholinergics and exhibit differences in pharmacokinetics. In total 496 patients were exposed to Kentera in the randomised, double-blind, placebo-controlled 12-week and the 14-week safety extension studies. Of these 188 patients (38%) were 65 years of age and older and exhibited no overall differences in safety or effectiveness compared to younger patients. Thus based on current clinical evidence no need for dose adjustment in elderly patients is considered necessary. Psychiatric and central nervous system (CNS) anticholinergic events like sleep disorders (e.g. insomnia) and cognitive disorders have been associated with oxybutynin use, especially in elderly patients. Caution should be exercised when oxybutynin is administrated concomitantly with other anticholinergic medicinal products (see also section 4.5). If a patient experiences such events, drug discontinuation should be considered. Other psychiatric events implying an anticholinergic mechanism have been reported during post- marketing use (see section 4.8). Oral administration of oxybutynin may warrant the following cautionary statements, but these events were not observed during clinical trials with Kentera: Gastrointestinal disorders: Anticholinergic medicinal products may decrease gastrointestinal motility and should be used with caution in patients with gastrointestinal obstructive disorders because of the risk of gastric retention. Also in conditions such as ulcerative colitis, and intestinal atony. 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. Anticholinergic medicinal products should be used with caution in pa

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