Kentera oxybutynin transdermal patch

  • Name:

    Kentera oxybutynin transdermal patch

  • Company:
    info
  • Active Ingredients:

    Oxybutynin

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 28/09/20

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Summary of Product Characteristics last updated on medicines.ie: 28/9/2020

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Recordati Ireland Limited

Recordati Ireland Limited

Company Products

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1 - 0 of 15 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 28 September 2020 PIL

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 SmPC

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 3 March 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 3 March 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 March 2017 SmPC

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 3 March 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 13 April 2015 SmPC

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

In Section 4.8 (undesirable effects) the reporting contacts have been added

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 8 April 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 1 July 2014 SmPC

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

Date of revision of text changed to be in line with EMA combined approved document - changes to PIL with no impact on SPC

Updated on 26 June 2014 PIL

Reasons for updating

  • Change of distributor details

Updated on 6 February 2012 SmPC

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

The SPC was revised together with the PIL after submission of the art. 61(3) to the EU commission for the change of company name of the local representative in Austria and Germany as listed on the current PIL. There were no specific changes to the SPC text.

Updated on 3 February 2012 PIL

Reasons for updating

  • Change of distributor details

Updated on 14 October 2010 SmPC

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

The shelf life was two years and is now three years.

Updated on 13 October 2010 PIL

Reasons for updating

  • Change of distributor details

Updated on 14 August 2009 SmPC

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

The main changes are to make the SPC clearer.  There are no real substantive changes; mostly changes to wording.  The undesirable effects changes are to remove comparisons with placebo and to categorise the ADRs in the accepted broad categories, rather than give specific values.

Updated on 14 November 2008 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 7 November 2008 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)