Kentera oxybutynin transdermal patch * Pharmacy Only: Prescription
Company:
Recordati Ireland LimitedStatus:
DiscontinuedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 28 September 2020
File name
Kentera PIL_1601279357.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
MA holder updated
Updated on 28 September 2020
File name
Kentera SmPC_1601279308.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to MA holder
Updated on 03 March 2017
File name
PIL_13893_285.pdf
Reasons for updating
- New PIL for new product
Updated on 03 March 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 March 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.2 Posology and 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 recommended dose is one 3.9 mg transdermal patch applied twice weekly (every 3 to 4 days).
Elderly population
Based on clinical trial experience no dose adjustment is considered necessary in this population. Nonetheless 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 (see section 4.4).
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. Currently available data are described in section 4.8 but no recommendation on a posology can be made.
4.4 Special warnings and precautions for use
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 medicines (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 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.
4.8 Undesirable effects
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.
MedDRA System Organ Class |
Incidence |
Adverse reactions |
Infections and infestations |
Common |
Urinary tract infection |
Uncommon |
Upper respiratory tract infection, fungal infection |
|
Psychiatric disorders |
Uncommon |
Anxiety, confusion, nervousness, agitation, insomnia |
Rare |
Panic reaction#, delirium#, hallucinations#, disorientation# |
|
Nervous system disorders |
Common |
Headache, somnolence |
Rare |
Memory impairment#, amnesia#, lethargy#, disturbance in attention# |
|
Eye disorders |
Common |
Blurred vision |
Ear and labyrinth disorders |
Common |
Dizziness |
Cardiac disorders |
Uncommon |
Palpitations |
Vascular disorders |
Uncommon |
Urticaria, hot flushes |
Respiratory, thoracic and mediastinal disorders |
Uncommon |
Rhinitis |
Gastrointestinal disorders |
Common |
Dry mouth, constipation, diarrhoea, nausea, abdominal pain |
Uncommon |
Abdominal discomfort, dyspepsia |
|
Musculoskeletal and connective tissue disorders |
Uncommon |
Back pain |
Renal and urinary disorders |
Uncommon |
Urinary retention, dysuria |
General disorders and administration site conditions |
Very common |
Application site pruritis |
Common |
Application site erythema, application site reaction, application site rash |
|
Injury, poisoning and procedural complications |
Uncommon |
Inflicted injury |
# 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 HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
4.9 Overdose
Plasma concentration of oxybutynin declines within 1 to 2 hours after removal of transdermal system(s). Patients should be monitored until symptoms resolve. Overdosage with oxybutynin has been associated with anticholinergic effects including central nervous system (CNS) excitation, flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention. Ingestion of 100 mg oral oxybutynin chloride in association with alcohol has been reported in a 13 year old boy who experienced memory loss, and in a 34 year old woman who developed stupor, followed by disorientation and agitation on awakening, dilated pupils, dry skin, cardiac arrhythmia, and retention of urine. Both patients recovered fully with symptomatic treatment.
No cases of overdose have been reported with Kentera.
Updated on 03 March 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 13 April 2015
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
Updated on 08 April 2015
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 01 July 2014
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 26 June 2014
Reasons for updating
- Change of distributor details
Updated on 06 February 2012
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change of distributor details
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 03 February 2012
Reasons for updating
- Change of distributor details
Updated on 14 October 2010
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 13 October 2010
Reasons for updating
- Change of distributor details
Updated on 14 August 2009
Reasons for updating
- Change to section 4 - Clinical particulars
- Change to section 10 - Date of revision of the text
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 6 - Pharmaceutical particulars
- Change to section 3 - Pharmaceutical form
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 14 November 2008
Reasons for updating
- New PIL for medicines.ie
Updated on 07 November 2008
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)