Page 8 - P4304.1-V95_PS-Magazine-March 2024 PRINT

Kentera® (oxybutynin)

3.9mg/24h Transdermal Patch

8 Patch

Kentera® (oxybutynin) 3.9mg/24h
Product Presentation
Transdermal patch
Pack Size 8 Patch
Product Format Transdermal Patch
Legal Category POM
Pack Dimensions (HxWxD) 108mm x 25mm x 95mm
Shelf Life 36 months BACK IN STOCK • BACK IN STOCK • BACK IN STOCK • BACK IN STOCK • BACK IN STOCK • BACK IN STOCK • BACK IN STOCK •

PIP Code 315-0018 . . .
EAN Code 5012617001962 BACK IN

STOCK
. . .
Prescribing Information
Kentera® (oxybutynin) 3.9mg/24h Transdermal patch
Please refer to the Summary of Product Characteristics (SmPC) before prescribing.

Presentation: Each transdermal patch contains 36mg of evidence there is no need for dose adjustment in elderly patients. When oxybutynin is used during breast-feeding, a small amount is
oxybutynin. The area of the patch is 39cm2, releasing a nominal Psychiatric and central nervous system (CNS) anticholinergic events excreted in the mother’s milk. Use of oxybutynin while breast-feeding
3.9 mg of oxybutynin per 24 hours. The patch is a clear plastic with an like sleep disorders (e.g. insomnia) and cognitive disorders have been is therefore not recommended.
adhesive backing, protected by a release liner that is to be removed prior associated with oxybutynin use, especially in elderly patients. Caution
to application. should be exercised when oxybutynin is administrated concomitantly Adverse Events include:
Indications: Symptomatic treatment of urge incontinence and/or with other anticholinergic medicines. If patients experience such Adverse events which could be considered serious: Urinary tract infection,
increased urinary frequency and urgency as may occur in adult patients events, drug discontinuation should be considered. Other psychiatric upper respiratory tract infection, fungal infection, delirium, hallucinations,
with unstable bladder. events implying an anticholinergic mechanism have been reported amnesia, rhinitis, urinary retention, tachycardia, arrhythmia, convulsion,
during post-marketing use. Gastrointestinal disorders: Anticholinergic intraocular hypertension, glaucoma, erectile dysfunction.
Dosage and Administration: The patch should be applied to dry, medicinal products may decrease gastrointestinal motility and should
intact skin on the abdomen, hip, or buttock immediately after removal be used with caution in patients with gastrointestinal obstructive Other Very Common adverse events: Application site pruritis.
from the protective sachet. A new application site should be selected disorders because of the risk of gastric retention. Also in conditions Other Common adverse events: Headache, somnolence, blurred vision,
with each new patch to avoid reapplication to the same site within such as ulcerative colitis, and intestinal atony. Anticholinergic medicinal dizziness, dry mouth, constipation, diarrhoea, nausea, abdominal pain,
7 days. The recommended dose is one 3.9 mg transdermal patch applied products should be used with caution in patients who have hiatus application site erythema, application site reaction, application site rash.
twice weekly (every 3 to 4 days). Elderly: No dose adjustment required. hernia/gastro-oesophageal reflux and/or who are concurrently taking
Paediatric population: Safety and efficacy have not been established medicinal products (such as bisphosphonates) that can cause or See SmPC for details of other adverse events.
so not recommended. exacerbate oesophagitis. Anticholinergic medicinal products should Presentation and Price: 8 patches £27.20
Contraindications: Hypersensitivity to the active substance or to any be used with caution in patients who have autonomic neuropathy, Legal Category: POM
of the excipients. Contraindicated in patients with urinary retention, cognitive impairment or Parkinson’s disease. Patients should be
severe gastro-intestinal condition, myasthenia gravis or narrow-angle informed that heat prostration (fever and heat stroke due to decreased Further information is available from:
glaucoma and in patients who are at risk for these conditions. sweating) can occur when anticholinergics such as oxybutynin are Accord-UK Ltd, Whiddon Valley, Barnstaple, Devon, EX32 8NS.
Warnings and Precautions: Kentera should be used with caution used in a hot environment. Oxybutynin may exacerbate the symptoms Marketing Authorisation Numbers: PLGB 0142/1151
in patients with hepatic or renal impairment, and patients with of hyperthyroidism, coronary heart disease, congestive heart
failure, cardiac arrhythmias, tachycardia, hypertension and prostatic Date of PI Preparation: February 2022
hepatic impairment should be carefully monitored. Other causes of
frequent urination (heart failure or renal disease) should be assessed hypertrophy. Oxybutynin may lead to suppressed salivary secretions Document number: UK-03757
before treatment with Kentera. If urinary tract infection is present, which could result in dental caries, parodontosis or oral candidiasis.
appropriate antibacterial therapy should be started. Urinary retention: Effects on ability to drive and use machines: Kentera may produce Adverse events should be reported.
Anticholinergic products should be administered with caution to drowsiness, somnolence, or blurred vision, therefore patients should be Reporting forms and information can be found at
patients with clinically significant bladder outflow obstruction because advised to exercise caution when driving or using machinery. www.mhra.gov.uk/yellowcard
of the risk of urinary retention. Use with caution in elderly patients, who Fertility, Pregnancy & Lactation: There are no adequate data
may be more sensitive to the effects of centrally acting anticholinergics on the use of oxybutynin transdermal patch in pregnant women. Adverse events should also be reported to Accord-UK LTD on
01271 385257 or email medinfo@accord-healthcare.com.
and exhibit differences in pharmacokinetics. Based on current clinical Kentera should not be used during pregnancy unless clearly necessary.

UK-04230 | Date of Preparation: July 2022

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