Kentera (Previously Oxybutynin Nicobrand)

9 mg transdermal patch applied twice weekly (every 3 to 4 days). Elderly Based on clinical trial experience no dose adjustment is considered necessary in this population. 4). Paediatric population The safety and efficacy of Kentera in the paediatric population has not been established.

Kentera is not recommended for use in the paediatric population. 8 but no recommendation on a posology can be made. Method of administration The patch should be applied to dry, intact skin on the abdomen, hip, or buttock immediately after removal from the protective sachet.

A new application site should be selected with each new patch to avoid reapplication to the same site within 7 days. The patch must not be divided or cut into pieces. Patches that are damaged should not be used.

1% of patients. 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 (MedDRA) Frequency Adverse reaction Infections and infestations Common Urinary tract infection Uncommon Upper respiratory tract infection, fungal infection Psychiatric disorders Uncommon Anxiety, confusion, nervousness, agitation, insomnia 5 # post-marketing adverse reactions from post-marketing reports only (not seen in clinical trials), with the frequency category estimated from clinical trial safety data, and reported in association with oxybutynin topical use (anticholinergic class effects).

Adverse reactions considered associated with anticholinergic therapy, in general or observed with oral administration of oxybutynin, but as of yet not with Kentera in clinical trials or post-marketing, are: anorexia, vomiting, reflux oesophagitis, decreased sweating, heat stroke, decreased lacrimation, mydriasis, tachycardia, arrhythmia, nightmares, restlessness, convulsion, intraocular hypertension and induction of glaucoma, paranoia, photosensitivity, erectile dysfunction.

Paediatric population During post-marketing use in this age group, cases of hallucinations (associated with anxiety manifestations) and sleep disorders correlated with oxybutynin have been reported. Children may be more sensitive to the effects of the product, particularly the CNS and psychiatric adverse reactions.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

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. g. insomnia) and cognitive disorders have been associated with oxybutynin use, especially in elderly patients. 5). If a patient experiences such events, drug discontinuation should be considered.

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 patients who have autonomic neuropathy, cognitive impairment or Parkinson's disease. Patients should be informed that heat prostration (fever and heat stroke due to decreased sweating) can occur when anticholinergics such as oxybutynin are used in a hot environment.

Oxybutynin may exacerbate the symptoms of hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, hypertension and prostatic hypertrophy. Oxybutynin may lead to suppressed salivary secretions which could result in dental caries, parodontosis or oral candidiasis.

1. 3 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.