Kentera

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



 2 

1. NAME OF THE MEDICINAL PRODUCT 
 
Kentera 3.9 mg / 24 hours transdermal patch 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each transdermal patch contains 36 mg of oxybutynin. The area of the patch is 39 cm2, releasing a 
nominal 3.9 mg of oxybutynin per 24 hours. 
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Transdermal patch. The patch is a clear plastic with an adhesive backing, protected by a release liner 
that is to be removed prior to application. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may 
occur in adult patients with unstable bladder. 
 
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. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients. 
 
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. 
 
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 



 3 

(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. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
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. 
 
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 CYP 3A4, interactions with medicinal products that 
inhibit this isoenzyme cannot be ruled out. This should be borne in mind when using azole antifungals 
(e.g. ketoconasole) or macrolide antibiotics (e.g. erythromycin) concurrently with oxybutynin. 
 



 4 

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. 
4.6 Pregnancy and lactation 
 
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. 
 
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. 
 
4.7 Effects on ability to drive and use machines 
 
No studies on the effects on the ability to drive and use machines have been performed. 
 
Because Kentera may produce drowsiness, somnolence, or blurred vision, patients should be advised 
to exercise caution when driving or using machinery (see section 4.5). 
 
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. 
 



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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. 
 



 6 

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. 
 
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 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. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: urinary antispasmodic, ATC code: G04B D04. 
 
Mechanism of action: oxybutynin acts as a competitive antagonist of acetylcholine at post-ganglionic 
muscarinic receptors, resulting in relaxation of bladder smooth muscle. 
 
Pharmacodynamic effects:  
In patients with overactive bladder, characterised by detrusor muscle instability or hyperreflexia, 
cystometric studies have demonstrated that oxybutynin increases maximum urinary bladder capacity 
and increases the volume to first detrusor contraction. Oxybutynin thus decreases urinary urgency and 
the frequency of both incontinence episodes and voluntary urination. 
 
Oxybutynin is a racemic (50:50) mixture of R- and S-isomers. Antimuscarinic activity resides 
predominantly in the R-isomer. The R-isomer of oxybutynin shows greater selectivity for the M1 and 
M3 muscarinic subtypes (predominant in bladder detrusor muscle and parotid gland) compared to the 
M2 subtype (predominant in cardiac tissue). The active metabolite, N-desethyloxybutynin, has 
pharmacological activity on the human detrusor muscle that is similar to that of oxybutynin in vitro 
studies, but has a greater binding affinity for parotid tissue than oxybutynin. The free base form of 
oxybutynin is pharmacologically equivalent to oxybutynin hydrochloride. 
 
Clinical efficacy:  
A total of 957 patients with urge urinary incontinence were evaluated in three controlled studies 
comparing Kentera to either placebo, oral oxybutynin and/or tolterodine long acting capsules. 
Reductions in weekly incontinence episodes, urinary frequency, and urinary void volume were 
evaluated. Kentera led to consistent improvements in overactive bladder symptoms compared with 
placebo. 
 
5.2 Pharmacokinetic properties 
 
Absorption 
Kentera has a concentration of oxybutynin sufficient to maintain continuous transport over the 3 to 4 
day dosing interval. Oxybutynin is transported across intact skin and into the systemic circulation by 
passive diffusion across the stratum corneum. Following the application of Kentera, oxybutynin 
plasma concentration increases for approximately 24 to 48 hours, reaching average maximum 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 7 

concentrations of 3 to 4 ng/ml. Steady-state conditions are reached during the second application of 
the transdermal patch. Thereafter, steady concentrations are maintained for up to 96 hours. The 
difference in AUC and Cmax of oxybutynin and the active metabolite N-desethyloxybutynin following 
transdermal administration of Kentera on either the abdomen, buttocks or hip is not clinically relevant. 
 
Distribution 
Oxybutynin is widely distributed in body tissues following systemic absorption. The volume of 
distribution was estimated to be 193 l after intravenous administration of 5 mg oxybutynin 
hydrochloride. 
 
Metabolism 
Oxybutynin administered orally is metabolised primarily by the cytochrome P450 enzyme systems, 
particularly CYP3A4, found mostly in the liver and gut wall. Metabolites include 
phenylcyclohexylglycolic acid, which is pharmacologically inactive, and N-desethyloxybutynin, 
which is pharmacologically active. Transdermal administration of oxybutynin bypasses the first-pass 
gastrointestinal and hepatic metabolism, reducing the formation of the N-desethyl metabolite.  
 
Excretion 
Oxybutynin is extensively metabolised by the liver, see above with less than 0.1% of the administered 
dose excreted unchanged in the urine. Also, less than 0.1% of the administered dose is excreted as the 
metabolite N-desethyloxybutynin. 
 
5.3 Preclinical safety data 
 
Pre-clinical data reveal no special hazard for humans based on studies for acute toxicology, repeat dose 
toxicity, genotoxicity, carcinogenic potential and local toxicity. At a concentration of 0.4 mg/kg/day 
oxybutynin administered subcutaneously, the occurrence of organ anomalies is significantly increased, 
but is observed only in the presence of maternal toxicity. Kentera delivers approximately 0.08 
mg/kg/day. However, in the absence of understanding the association between maternal toxicity and 
developmental effect, the relevance to human safety cannot be addressed. In the subcutaneous fertility 
study in rats, while no effects were reported in males, in females, fertility was impaired and a NOAEL 
(no observed adverse effect level) of 5 mg/kg was identified. 
 
Environmental Risk Assessment 
The active substance oxybutynin is persistent in the environment. 
 
 
6 PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Backing film 
Clear polyester/ethylene-vinyl acetate (PET/EVA) 
 
Middle layer 
Triacetin 
Acrylic copolymer adhesive solution containing 2-ethylhexyl acrylate N-vinyl pyrrolidone and 
hexamethyleneglycol dimethacrylate polymer domains 
 
Release Liner 
Siliconised polyester 
 
6.2 Incompatibilities 
 
Not applicable. 
 



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6.3 Shelf life 
 
3 years. 
 
6.4 Special precautions for storage 
 
Do not refrigerate or freeze.  
 
6.5 Nature and contents of container 
 
The transdermal patches are individually contained in LDPE/paper laminate sachets and supplied in 
Patient Calendar Boxes of 2, 8 or 24 patches.  
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
Apply immediately upon removal from the protective sachet. After use the patch still contains 
substantial quantities of active ingredients. Remaining active ingredients of the patch may have 
harmful effects if reaching the aquatic environment. Hence, after removal, the used patch should be 
folded in half, adhesive side inwards so that the release membrane is not exposed, placed in the 
original sachet and then discarded safely out of reach of children. Any used or unused patches should 
be discarded according to local requirements or returned to the pharmacy. Used patches should not be 
flushed down the toilet nor placed in liquid waste disposal systems. 
 
Activities that may lead to excessive sweating, or exposure to water or extreme temperature may 
contribute to adhesion problems. Do not expose the patch to the sun. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031 GA Haarlem 
The Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/03/270/001 8 transdermal patches 
EU/1/03/270/002 24 transdermal patches 
EU/1/03/270/003 2 transdermal patches 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 15/06/2004 
Date of latest renewal: 30/04/2009 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this product is available on the website of the European Medicines Agency 
(EMA) http://www.ema.europa.eu 
 

http://www.ema.europa.eu/


 9 

1. NAME OF THE MEDICINAL PRODUCT 
 
Kentera 90.7 mg/g gel in sachet 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each sachet of 1 gram of gel contains 90.7 mg of oxybutynin (as 100 mg oxybutynin hydrochloride) 
resulting in a nominal delivery of approximately 4 mg/day. 
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Gel in sachet. 
Rapid drying, clear, smooth, odourless, and colourless hydroalcoholic gel. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may 
occur in adult patients with unstable bladder  
 
4.2 Posology and method of administration 
 
Posology 
 
The recommended dose is one sachet applied once daily which corresponds to a delivery dose of 
approximately 4 mg. 
  
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). 
 
Renal impairment 
 
There is no experience with the use of Kentera in patients with renal impairment. 
 
Hepatic impairment 
 
There is no experience with the use of Kentera in patients with hepatic impairment. 
 
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. 
 



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Method of administration 
 
Kentera should be applied to dry, intact skin on the abdomen, upper arms/shoulders, or thighs.  
Application sites should be rotated.  Application should not be made to the same site on consecutive 
days. 
 
Avoid bathing, swimming, showering, exercising or immersing the application site in water for one 
hour after application (see section 4.4). 
 
It is recommended to cover the application site with clothing once the gel has dried. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients. 
 
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. 
 
4.4 Special warnings and special precautions for use 
 
As the stratum corneum is the rate-limiting step in transdermal delivery, any breach would provide 
direct access to the epidermis, potentially increasing penetration and facilitating the migration of the 
medicinal product to the blood stream. Kentera should therefore not be applied to a recently shaved or 
damaged skin surface. 
 
Avoid bathing, swimming, showering, exercising or immersing the application site in water for one 
hour after application. 
 
It is recommended to cover the application site with clothing once Kentera has dried. 
 
The effect of fever, exposition to external heat sources, sun bathing and sauna on the absorption 
characteristics of Kentera have not been investigated. 
 
Impaired metabolism 
 
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 since oxybutynin is extensively 
hepatic metabolised. 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 medicinal products should be administered with caution to patients with clinically 
significant bladder outflow obstruction because of the risk of urinary retention. 
 
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, 
and 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 



 11 

are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate 
oesophagitis. 
 
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). 
 
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. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
The concomitant use of oxybutynin with other anticholinergic medicinal products or with other active 
substances that compete for CYP3A4 enzyme metabolism may increase the frequency or severity of 
dry mouth, constipation, and drowsiness.  As oxybutynin is metabolised by the cytochrome P 450 
isoenzyme CYP 3A4, interactions with medicinal products that inhibit this isoenzyme, or known 
inducers of CYP 3A4, cannot be ruled out.  This should be borne in mind when administering azole 
antifungals (e.g. ketoconazole) or macrolide antibiotics (e.g. erythromycin) concurrently with 
oxybutynin.  Consumption of grapefruit juice may also influence metabolism of oxybutynin. 
 
Anticholinergic medicinal products may potentially alter the absorption of some concomitantly 
administered medicinal products due to anticholinergic effects on gastrointestinal motility.  
 
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, and dipyridamole. 
 
Oxybutynin may cause drowsiness or blurred vision.  Drowsiness may be increased by consumption of 
alcohol.  Because Kentera may cause drowsiness, somnolence, or blurred vision, patients should be 
advised to exercise caution when driving or using machinery (see section 4.7). 
 



 12 

Oxybutynin may antagonise prokinetic therapies, such as cisapride and metocloparamide, and should 
be avoided in the presence of reduced gastrointestinal motility conditions. 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential/Contraception in males and females 
 
Women of childbearing age should be tested for pregnancy before beginning therapy, and during 
therapy utilise some form of pregnancy contraceptive. 
 
Pregnancy 
 
There are no adequate data on the use of oxybutynin topical gel in pregnant women.  Studies in 
animals have shown minor reproductive toxicity (see section 5.3). Kentera should not to be used 
during pregnancy unless clearly necessary. 
 
Breast-feeding 
 
Available information shows that oxybutynin is excreted in milk of rats, but is not known whether 
oxybutynin is excreted in human milk. Use of oxybutynin is not recommended during breast-feeding.  
 
Fertility 
 
Data on possible effects of the use of oxybutynin on human male and female fertility are not available.  
Fertility studies in rats suggest a 6-fold margin of safety in both male and female breeding adults when 
Kentera is administered as prescribed. (see section 5.3) 
 
Patients on Kentera therapy should keep application sites covered with clothing when coming into 
contact with breast-feeding or pregnant women or breast-fed infants. 
 
4.7 Effects on ability to drive and use machines 
 
Kentera has minor influence on the ability to drive and use machines.  Because Kentera may cause 
drowsiness, somnolence, or blurred vision, patients should be advised to exercise caution when driving 
or using machinery (see section 4.5). 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The safety of Kentera was evaluated in patients with urge urinary incontinence in a randomised, 
double-blind, placebo-controlled, parallel group Phase 3 study that included 789 patients (with 
389 patients receiving Kentera and 400 patients receiving placebo). 
 
The most commonly reported adverse reaction was dry mouth (Kentera 6.9%, placebo 2.8%). Other 
adverse reactions reported were application site pruritus (Kentera 2.1%, placebo 0.8%), application 
site dermatitis (Kentera 1.8%, placebo 0.3%), dizziness (Kentera 1.5%, placebo 0.5%), headache 
(Kentera 1.5%, placebo 2.8%), constipation (Kentera 1.3%, placebo 1.0%), and pruritus (Kentera 
1.3%, placebo 1.3%). 
 
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. 



 13 

 
MedDRA 

System Organ Class 

Incidence Adverse reactions 

Infections and infestations Uncommon Urinary tract infections 
Metabolism and nutrition 
disorders 

Uncommon Hypokalaemia 

Psychiatric disorders Uncommon Anxiety, confusion, nervousness, agitation, 
insomnia 

Rare Panic reaction#, delirium#, hallucinations#, 
disorientation#  

Nervous system disorders Common Headache, dizziness 
Uncommon Somnolence, dysgeusia, poor quality to sleep, 

tremor 
Rare Memory impairment#, amnesia#, lethargy#, 

disturbance in attention#  
Eye disorders Uncommon Dry eye 
Ear and labyrinth 
disorders 

Uncommon Vertigo 

Cardiac disorders Uncommon Atrial fibrillation, atrial flutter, sinus arrhythmia 
Vascular disorders Uncommon Flushing 
Respiratory thoracic and 
mediastinal disorders 

Uncommon Cough, increased upper airway secretion 

Gastrointestinal disorders Common Dry mouth, constipation 
Uncommon Diarrhoea, nausea, dyspepsia, vomiting, 

haemorrhoids 
Skin and subcutaneous 
tissue disorders 

Common Pruritus 
Uncommon Rash, dry skin, rash pruritic 

Renal and urinary 
disorders 

Uncommon Dysuria, haematuria, renal pain, urinary retention 

General disorders and 
administration site 
conditions 

Common Application site pruritis, application site dermatitis 
Uncommon Fatigue, oedema peripheral, application site 

papules, application site anaesthesia, application 
site erythema, application site irritation, application 
site pain, application site pustules 

Investigations Uncommon Electrocardiogram abnormal, electrocardiogram 
change, blood chloride increased 

 
# 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  



 14 

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. 

 
4.9 Overdose 
 
Overdose with oxybutynin has been associated with anticholinergic effects including CNS excitation, 
flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention.  Patients should be 
monitored until symptoms resolve.  Plasma concentrations of oxybutynin begin to decline 24 hours 
after Kentera application. Ingestion of 100 mg oral oxybutynin 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. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Urologicals, urinary antispasmodics, ATC code: G04B D04. 
 
Mechanism of action 
 
Oxybutynin acts as a competitive antagonist of acetylcholine at post-ganglionic muscarinic receptors, 
resulting in relaxation of bladder smooth muscle. 
 
Pharmacodynamic effects 
 
In patients with overactive bladder, characterised by detrusor muscle instability or hyperreflexia, 
cystometric studies have demonstrated that oxybutynin increases maximum urinary bladder capacity 
and increases the volume to first detrusor contraction.  Oxybutynin thus decreases urinary urgency and 
the frequency of both incontinence episodes and voluntary urination. 
 
Oxybutynin is a racemic (50:50) mixture of R- and S-isomers.  Antimuscarinic activity resides 
predominantly in the R-isomer.  The R-isomer of oxybutynin shows greater selectivity for the M1 and 
M3 muscarinic subtypes (predominant in bladder detrusor muscle and parotid gland) compared to the 
M2 subtype (predominant in cardiac tissue).  The active metabolite, N-desethyloxybutynin, has 
pharmacological activity on the human detrusor muscle that is similar to that of oxybutynin in vitro 
studies, but has a greater binding affinity for parotid tissue than oxybutynin.  The free base form of 
oxybutynin is pharmacologically equivalent to oxybutynin hydrochloride. 
 
Clinical efficacy 
 
The efficacy and safety of Kentera were evaluated in patients with urge urinary incontinence in a 
single Phase 3 study.  
 
The Phase 3 study was a randomised, double-blind, placebo-controlled, parallel group study that 
included 789 patients. The 12-week double-blind treatment included daily applications of Kentera or 
matching placebo gel. A 14-week, open-label treatment was available for a subset of patients who 
completed the double-blind period. The majority of patients were Caucasian (86.3%) and female 

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 15 

(89.2%), with a mean age of 59.4 years (range: 18 to 88 years). Approximately 75% of patients had no 
prior pharmacological treatment for incontinence. 
 
Patients treated with Kentera experienced a highly statistically significant decrease in the number of 
urinary incontinence episodes per day from baseline to endpoint (the primary efficacy endpoint) 
compared with placebo (p<0.0001), as well as for the secondary endpoints:  a decrease in the average 
daily urinary frequency (p=0.0017), and an increase in the average urine volume per void (p=0.0018).  
Significant improvements in the quality of life evaluations measured during the study were also 
observed with Kentera. 
 
Mean and median change from baseline in daily incontinence episodes (primary endpoint), urinary 
frequency, and urinary void volume between placebo and active treatment groups are summarised in 
the table below. 
 

Mean and median change from baseline for incontinence episodes, urinary frequency, 
and urinary void volume at Week 12 (LOCF) 

Parameter 

Kentera Placebo 
(N=389) (N=400) 

Mean (SD) Median Mean (SD) Median 
Daily incontinence episodes   

Baseline 5.4 (3.26) 4.7 5.4 (3.28) 4.7 
Change from baseline -3.0 (2.73) -2.7 -2.5 (3.06) -2.0 
P-value vs. placebo <0.0001 -- 

   
Daily urinary frequency   

Baseline 12.4 (3.34) 11.7 12.2 (3.32) 11.3 
Change from baseline -2.7 (3.21) -2.7 -2.0 (2.82) -1.7 
P-value vs. placebo 0.0017 -- 

   
Urinary void volume (ml)   

Baseline 163.4 (65.85) 160.1 167.9 (68.40) 160.6 
Change from baseline 21.0 (65.33) 11.5 3.8 (53.79) 0.0 
P-value vs. placebo 0.0018 -- 

   
Daily nocturia episodes   

Baseline 2.5 (1.61) 2.3 2.5 (1.71) 2.3 
Change from baseline -0.7 (1.40) -0.7 -0.7 (1.32) -0.7 
P-value vs. placebo 0.1372 -- 

  
During the double-blind treatment a significant positive effect on quality of life was seen with Kentera 
based on the Incontinence Impact Questionnaire (IIQ). These results were evident after the first month 
of treatment and were maintained throughout double-blind treatment as shown in the table below. 



 16 

 
Mean (SD) change from baseline for IIQ total score and subscales at Week 12 (LOCF) 

Score 
Kentera 
(N=389) 

Placebo 
(N=400) 

P-value 
(Kentera vs. 

Placebo) 

Total score -72.1 (80.01) -49.5 (76.59) 0.0005 
    Travel subscale -20.9 (25.55) -15.1 (24.82) 0.0068 
    Physical activity subscale -18.0 (23.23) -13.0 (21.68) 0.0078 
    Social relationships subscale -15.2 (20.07) -9.7 (19.27) 0.0019 
    Emotional health subscale -18.1 (21.96) -11.8 (20.64) 0.0002 

 
Significant positive effects were also noted for each subscale domain of the IIQ and for six of ten 
quality of life domains, including the incontinence impact domain, of the King’s Health Questionnaire 
(KHQ) as shown in the table below. 
 

Mean (SD) change from baseline in KHQ Domain Scores at Week 12 (LOCF) 

Domain 
 

Kentera 
(N=389) 

Placebo 
(N=400) 

P-value 
(Kentera vs. 

Placebo) 
General health perception 0.4 (12.23) 0.1 (11.94) 0.6528 
    Incontinence impact -27.9 (30.02) -21.3 (27.05) 0.0023 
    Symptom severity -20.6 (22.90) -15.8 (21.84) 0.0024 
    Role limitations  -27.1 (29.24) -21.3 (27.16) 0.0133 
    Physical limitations  -20.2 (30.04) -16.8 (28.12) 0.1064 
    
Social limitations -11.5 (24.40) -10.3 (23.46) 0.4468 
    
Personal relationships -11.2 (24.96) -6.2 (19.77) 0.0489 
    
Emotions -11.7 (24.59) -8.4 (24.89) 0.0649 
    
Sleep and energy -15.6 (24.18) -10.3 (22.42) 0.0061 
    
Severity (coping) measures -15.3 (21.40) -11.1 (19.16) 0.0058 

 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Kentera is formulated for daily application and is capable of maintaining therapeutic blood levels of 
oxybutynin.  Oxybutynin is transported across intact skin and into the systemic circulation by passive 
diffusion across the stratum corneum. Following the application of Kentera, oxybutynin plasma 
concentration increases for approximately 7 days, reaching average maximum concentrations of 4 to 
5 ng/ml.  Steady-state conditions are reached after the seventh day of administration.  The difference 
in AUC and Cmax of oxybutynin and the active metabolite N-desethyloxybutynin following 



 17 

transdermal administration of Kentera on either the abdomen, upper arms/shoulders and thighs is not 
clinically relevant. 
 
Distribution 
 
Oxybutynin is widely distributed in body tissues following systemic absorption.  The volume of 
distribution was estimated to be 193 l after intravenous administration of 5 mg oxybutynin 
hydrochloride. 
 
Biotransformation 
 
Oxybutynin administered orally is metabolised primarily by the cytochrome P450 enzyme systems, 
particularly CYP3A4, found mostly in the liver and gut wall.  The expression of CYP3A and CYP3A4 
may vary by as much as 40 fold due to genetic polymorphism.  Metabolites include 
phenylcyclohexylglycolic acid, which is pharmacologically inactive, and N-desethyloxybutynin, 
which is pharmacologically active.  Transdermal administration of oxybutynin bypasses the first-pass 
gastrointestinal and hepatic metabolism, reducing the formation of the N-desethyl metabolite.  
Excretion 
 
Oxybutynin is extensively metabolised by the liver, see above, with less than 0.1% of the administered 
dose excreted unchanged in the urine.  Also, less than 0.1% of the administered dose is excreted as the 
metabolite N-desethyloxybutynin. 
 
Person-to-person transference 
 
The potential for dermal transfer of oxybutynin from a treated person to an untreated person was 
evaluated in a single-dose study where subjects dosed with Kentera engaged in vigorous contact with 
an untreated partner for 15 minutes, either with (N=14 couples) or without (N=12 couples) clothing 
covering the application area.  The untreated partners not protected by clothing demonstrated 
detectable plasma concentrations of oxybutynin (mean Cmax = 0.94 ng/ml).  Two of the 14 untreated 
subjects participating in the clothing-to-skin contact regimen had measurable oxybutynin plasma 
concentrations (Cmax  < 0.1 ng/ml) during the 48 hours following contact with treated subjects; 
oxybutynin was not detectable with the remaining 12 untreated subjects. 
 
Effects of showering 
 
The effect of showering on the absorption of oxybutynin was evaluated in a randomised, steady-state 
crossover study under conditions of no shower, or showering 1, 2 or 6 hours after Kentera application 
(N=20).  The results of the study indicate that showering after one hour does not affect the overall 
systemic exposure to oxybutynin. 
 
Use with sunscreen 
 
The effect of sunscreen on the absorption of oxybutynin when applied 30 minutes before or 
30 minutes after Kentera application was evaluated in a single-dose randomised crossover study 
(N=16).  Concomitant application of sunscreen, either before or after Kentera application, had no 
effect on the systemic exposure of oxybutynin. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on studies for acute toxicity, repeat dose 
toxicity, genotoxicity, carcinogenicity and local toxicity.  Adverse reactions were observed in 
embryotoxicity studies in the rabbit.  At a concentration of 0.4 mg/kg/day oxybutynin administered 
subcutaneously, the occurrence of organ anomalies is significantly increased, but is observed only in 
the presence of maternal toxicity.  However, in the absence of understanding the association between 
maternal toxicity and developmental effect, the relevance to human safety cannot be addressed.  In the 



 18 

subcutaneous fertility study in rats, while no effects were reported in males, in females, fertility was 
impaired and a NOAEL (no observed adverse effect level) of 5 mg/kg was identified. 
 
Environmental Risk Assessment 
The active substance oxybutynin is persistent in the environment. 
 
 
6 PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Ethanol (96 per cent) 
Glycerol 
Hydroxypropylcellulose 
Sodium hydroxide (for pH-adjustment) 
Purified water 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
2 years. 
 
6.4 Special precautions for storage 
 
Do not refrigerate or freeze. 
 
Kentera contains alcohol and is considered flammable and should not come in contact with an open 
flame. 
 
6.5 Nature and contents of container 
 
The sachet is constructed from a multi-layer foil based laminate pouch material 
(polymethacrylate/acrylonitrile copolymer/adhesive/aluminum/low density polyethylene/paper). 
 
Each sachet contains 1 g of gel. 
Cartons of 30 sachets. 
 
6.6 Special precautions for disposal and other handling 
 
After the sachets are opened and contents expelled, the gel should be used immediately. 
 
After applying the gel, hands should immediately be washed thoroughly with soap and water.  It is 
recommended to cover the application site with clothing once the gel has dried.  Avoid bathing, 
swimming, showering, exercising or immersing the application site in water for one hour after 
application. 
 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031 GA Haarlem 
The Netherlands 



 19 

 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/03/270/004 30 sachets 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 15/06/2004 
Date of latest renewal: 30/04/2009 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu 
  

http://www.ema.europa.eu/


 20 

1. NAME OF THE MEDICINAL PRODUCT 
 
Kentera 90.7 mg/g gel 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each metered dose of 1 gram of gel contains 90.7 mg of oxybutynin (as 100 mg oxybutynin 
hydrochloride) resulting in a nominal delivery of approximately 4 mg/day. 
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Gel. 
Rapid drying, clear, smooth, odourless, and colourless hydroalcoholic gel. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may 
occur in adult patients with unstable bladder  
 
4.2 Posology and method of administration 
 
Posology 
 
The recommended dose is one metered dose from the multidose container with metering pump applied 
once daily which corresponds to a delivery dose of approximately 4 mg.  
 
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). 
 
Renal impairment 
 
There is no experience with the use of Kentera in patients with renal impairment. 
 
Hepatic impairment 
 
There is no experience with the use of Kentera in patients with hepatic impairment. 
 
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. 
 



 21 

Method of administration 
 
Kentera should be applied to dry, intact skin on the abdomen, upper arms/shoulders, or thighs.  
Application sites should be rotated.  Application should not be made to the same site on consecutive 
days. 
 
Avoid bathing, swimming, showering, exercising or immersing the application site in water for one 
hour after application (see section 4.4). 
 
It is recommended to cover the application site with clothing once the gel has dried. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients. 
 
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. 

 
4.4 Special warnings and special precautions for use 
 
As the stratum corneum is the rate-limiting step in transdermal delivery, any breach would provide 
direct access to the epidermis, potentially increasing penetration and facilitating the migration of the 
medicinal product to the blood stream. Kentera should therefore not be applied to a recently shaved or 
damaged skin surface. 
 
Avoid bathing, swimming, showering, exercising or immersing the application site in water for one 
hour after application. 
 
It is recommended to cover the application site with clothing once Kentera has dried. 
 
The effect of fever, exposition to external heat sources, sun bathing and sauna on the absorption 
characteristics of Kentera have not been investigated. 
 
Impaired metabolism 
 
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 since oxybutynin is extensively 
hepatic metabolised. 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 medicinal products should be administered with caution to patients with clinically 
significant bladder outflow obstruction because of the risk of urinary retention. 
 
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, 
and 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 



 22 

are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate 
oesophagitis. 
 
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). 
 
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. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
The concomitant use of oxybutynin with other anticholinergic medicinal products or with other active 
substances that compete for CYP3A4 enzyme metabolism may increase the frequency or severity of 
dry mouth, constipation, and drowsiness.  As oxybutynin is metabolised by the cytochrome P 450 
isoenzyme CYP 3A4, interactions with medicinal products that inhibit this isoenzyme, or known 
inducers of CYP 3A4, cannot be ruled out.  This should be borne in mind when administering azole 
antifungals (e.g. ketoconazole) or macrolide antibiotics (e.g. erythromycin) concurrently with 
oxybutynin.  Consumption of grapefruit juice may also influence metabolism of oxybutynin. 
 
Anticholinergic medicinal products may potentially alter the absorption of some concomitantly 
administered medicinal products due to anticholinergic effects on gastrointestinal motility.  
 
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, and dipyridamole. 
 
Oxybutynin may cause drowsiness or blurred vision.  Drowsiness may be increased by consumption of 
alcohol.  Because Kentera may cause drowsiness, somnolence, or blurred vision, patients should be 
advised to exercise caution when driving or using machinery (see section 4.7). 
 



 23 

Oxybutynin may antagonise prokinetic therapies, such as cisapride and metocloparamide, and should 
be avoided in the presence of reduced gastrointestinal motility conditions. 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential/Contraception in males and females 
 
Women of childbearing age should be tested for pregnancy before beginning therapy, and during 
therapy utilise some form of pregnancy contraceptive. 
 
Pregnancy 
 
There are no adequate data on the use of oxybutynin topical gel in pregnant women.  Studies in 
animals have shown minor reproductive toxicity (see section 5.3). Kentera should not to be used 
during pregnancy unless clearly necessary. 
 
Breast-feeding 
 
Available information shows that oxybutynin is excreted in milk of rats, but is not known whether 
oxybutynin is excreted in human milk.  Use of oxybutynin is not recommended during breast-feeding.  
 
Fertility 
 
Data on possible effects of the use of oxybutynin on human male and female fertility are not available.  
Fertility studies in rats suggest a 6 fold margin of safety in both male and female breeding adults when 
Kentera is administered as prescribed (see section 5.3). 
 
Patients on Kentera therapy should keep application sites covered with clothing when coming into 
contact with breast-feeding or pregnant women or breast-fed infants. 
 
4.7 Effects on ability to drive and use machines 
 
Kentera has minor influence on the ability to drive and use machines. Because Kentera may cause 
drowsiness, somnolence, or blurred vision, patients should be advised to exercise caution when driving 
or using machinery (see section 4.5). 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The safety of Kentera was evaluated in patients with urge urinary incontinence in a randomised, 
double-blind, placebo-controlled, parallel group Phase 3 study that included 789 patients (with 
389 patients receiving Kentera and 400 patients receiving placebo). 
 
The most commonly reported adverse reaction was dry mouth (Kentera 6.9%, placebo 2.8%). Other 
adverse reactions reported were application site pruritus (Kentera 2.1%, placebo 0.8%), application 
site dermatitis (Kentera 1.8%, placebo 0.3%), dizziness (Kentera 1.5%, placebo 0.5%), headache 
(Kentera 1.5%, placebo 2.8%), constipation (Kentera 1.3%, placebo 1.0%), and pruritus (Kentera 
1.3%, placebo 1.3%). 
 
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. 



 24 

 
MedDRA 

System Organ Class 

Incidence Adverse reactions 

Infections and infestations Uncommon Urinary tract infections 
Metabolism and nutrition 
disorders 

Uncommon Hypokalaemia 

Psychiatric disorders Uncommon Anxiety, confusion, nervousness, agitation, 
insomnia 

Rare Panic reaction#, delirium#, hallucinations#, 
disorientation#  

Nervous system disorders Common Headache, dizziness 
Uncommon Somnolence, dysgeusia, poor quality to sleep, 

tremor 
Rare Memory impairment#, amnesia#, lethargy#, 

disturbance in attention# 
Eye disorders Uncommon Dry eye 
Ear and labyrinth 
disorders 

Uncommon Vertigo 

Cardiac disorders Uncommon Atrial fibrillation, atrial flutter, sinus arrhythmia 
Vascular disorders Uncommon Flushing 
Respiratory thoracic and 
mediastinal disorders 

Uncommon Cough, increased upper airway secretion 

Gastrointestinal disorders Common Dry mouth, constipation 
Uncommon Diarrhoea, nausea, dyspepsia, vomiting, 

haemorrhoids 
Skin and subcutaneous 
tissue disorders 

Common Pruritus 
Uncommon Rash, dry skin, rash pruritic 

Renal and urinary 
disorders 

Uncommon Dysuria, haematuria, renal pain, urinary retention 

General disorders and 
administration site 
conditions 

Common Application site pruritis, application site dermatitis 
Uncommon Fatigue, oedema peripheral, application site 

papules, application site anaesthesia, application 
site erythema, application site irritation, application 
site pain, application site pustules 

Investigations Uncommon Electrocardiogram abnormal, electrocardiogram 
change, blood chloride increased 

 
# 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. 
 



 25 

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. 

 
4.9 Overdose 
 
Overdose with oxybutynin has been associated with anticholinergic effects including CNS excitation, 
flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention.  Patients should be 
monitored until symptoms resolve.  Plasma concentrations of oxybutynin begin to decline 24 hours 
after Kentera application. Ingestion of 100 mg oral oxybutynin 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. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Urologicals, urinary antispasmodics, ATC code: G04B D04. 
 
Mechanism of action 
 
Oxybutynin acts as a competitive antagonist of acetylcholine at post-ganglionic muscarinic receptors, 
resulting in relaxation of bladder smooth muscle. 
 
Pharmacodynamic effects 
 
In patients with overactive bladder, characterised by detrusor muscle instability or hyperreflexia, 
cystometric studies have demonstrated that oxybutynin increases maximum urinary bladder capacity 
and increases the volume to first detrusor contraction.  Oxybutynin thus decreases urinary urgency and 
the frequency of both incontinence episodes and voluntary urination. 
 
Oxybutynin is a racemic (50:50) mixture of R- and S-isomers.  Antimuscarinic activity resides 
predominantly in the R-isomer.  The R-isomer of oxybutynin shows greater selectivity for the M1 and 
M3 muscarinic subtypes (predominant in bladder detrusor muscle and parotid gland) compared to the 
M2 subtype (predominant in cardiac tissue).  The active metabolite, N-desethyloxybutynin, has 
pharmacological activity on the human detrusor muscle that is similar to that of oxybutynin in vitro 
studies, but has a greater binding affinity for parotid tissue than oxybutynin.  The free base form of 
oxybutynin is pharmacologically equivalent to oxybutynin hydrochloride. 
 
Clinical efficacy 
 
The efficacy and safety of Kentera were evaluated in patients with urge urinary incontinence in a 
single Phase 3 study. 
 
The Phase 3 study was a randomised, double-blind, placebo-controlled, parallel group study that 
included 789 patients. The 12-week double-blind treatment included daily applications of Kentera or 
matching placebo gel. A 14-week, open-label treatment was available for a subset of patients who 
completed the double-blind period. The majority of patients were Caucasian (86.3%) and female 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 26 

(89.2%), with a mean age of 59.4 years (range: 18 to 88 years). Approximately 75% of patients had no 
prior pharmacological treatment for incontinence. 
 
Patients treated with Kentera experienced a highly statistically significant decrease in the number of 
urinary incontinence episodes per day from baseline to endpoint (the primary efficacy endpoint) 
compared with placebo (p<0.0001), as well as for the secondary endpoints: a decrease in the average 
daily urinary frequency (p=0.0017), and an increase in the average urine volume per void (p=0.0018).  
Significant improvements in the quality of life evaluations measured during the study were also 
observed with Kentera. 
 
Mean and median change from baseline in daily incontinence episodes (primary endpoint), urinary 
frequency, and urinary void volume between placebo and active treatment groups are summarised in 
the table below. 
 

Mean and median change from baseline for incontinence episodes, urinary frequency, 
and urinary void volume at Week 12 (LOCF) 

Parameter 

Kentera Placebo 
(N=389) (N=400) 

Mean (SD) Median Mean (SD) Median 
Daily incontinence episodes   

Baseline 5.4 (3.26) 4.7 5.4 (3.28) 4.7 
Change from baseline -3.0 (2.73) -2.7 -2.5 (3.06) -2.0 
P-value vs. placebo <0.0001 -- 

   
Daily urinary frequency   

Baseline 12.4 (3.34) 11.7 12.2 (3.32) 11.3 
Change from baseline -2.7 (3.21) -2.7 -2.0 (2.82) -1.7 
P-value vs. placebo 0.0017 -- 

   
Urinary void volume (ml)   

Baseline 163.4 (65.85) 160.1 167.9 (68.40) 160.6 
Change from baseline 21.0 (65.33) 11.5 3.8 (53.79) 0.0 
P-value vs. placebo 0.0018 -- 

   
Daily nocturia episodes   

Baseline 2.5 (1.61) 2.3 2.5 (1.71) 2.3 
Change from baseline -0.7 (1.40) -0.7 -0.7 (1.32) -0.7 
P-value vs. placebo 0.1372 -- 

  
During the double-blind treatment a significant positive effect on quality of life was seen with Kentera 
based on the Incontinence Impact Questionnaire (IIQ). These results were evident after the first month 
of treatment and were maintained throughout double-blind treatment as shown in the table below. 



 27 

 
Mean (SD) change from baseline for IIQ total score and subscales at Week 12 (LOCF) 

Score 
Kentera 
(N=389) 

Placebo 
(N=400) 

P-value 
(Kentera vs. 

Placebo) 

Total score -72.1 (80.01) -49.5 (76.59) 0.0005 
    Travel subscale -20.9 (25.55) -15.1 (24.82) 0.0068 
    Physical activity subscale -18.0 (23.23) -13.0 (21.68) 0.0078 
    Social relationships subscale -15.2 (20.07) -9.7 (19.27) 0.0019 
    Emotional health subscale -18.1 (21.96) -11.8 (20.64) 0.0002 

 
Significant positive effects were also noted for each subscale domain of the IIQ and for six of ten 
quality of life domains, including the incontinence impact domain, of the King’s Health Questionnaire 
(KHQ) as shown in the table below. 
 

Mean (SD) change from baseline in KHQ Domain Scores at Week 12 (LOCF) 

Domain 
 

Kentera 
(N=389) 

Placebo 
(N=400) 

P-value 
(Kentera vs. 

Placebo) 
General health perception 0.4 (12.23) 0.1 (11.94) 0.6528 
    Incontinence impact -27.9 (30.02) -21.3 (27.05) 0.0023 
    Symptom severity -20.6 (22.90) -15.8 (21.84) 0.0024 
    Role limitations  -27.1 (29.24) -21.3 (27.16) 0.0133 
    Physical limitations  -20.2 (30.04) -16.8 (28.12) 0.1064 
    
Social limitations -11.5 (24.40) -10.3 (23.46) 0.4468 
    
Personal relationships -11.2 (24.96) -6.2 (19.77) 0.0489 
    
Emotions -11.7 (24.59) -8.4 (24.89) 0.0649 
    
Sleep and energy -15.6 (24.18) -10.3 (22.42) 0.0061 
    
Severity (coping) measures -15.3 (21.40) -11.1 (19.16) 0.0058 

 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Kentera is formulated for daily application and is capable of maintaining therapeutic blood levels of 
oxybutynin.  Oxybutynin is transported across intact skin and into the systemic circulation by passive 
diffusion across the stratum corneum. Following the application of Kentera, oxybutynin plasma 
concentration increases for approximately 7 days, reaching average maximum concentrations of 4 to 
5 ng/ml.  Steady-state conditions are reached after the seventh day of administration.  The difference 
in AUC and Cmax of oxybutynin and the active metabolite N-desethyloxybutynin following 



 28 

transdermal administration of Kentera on either the abdomen, upper arms/shoulders and thighs is not 
clinically relevant. 
 
Distribution 
 
Oxybutynin is widely distributed in body tissues following systemic absorption.  The volume of 
distribution was estimated to be 193 l after intravenous administration of 5 mg oxybutynin 
hydrochloride. 
 
Biotransformation 
 
Oxybutynin administered orally is metabolised primarily by the cytochrome P450 enzyme systems, 
particularly CYP3A4, found mostly in the liver and gut wall.  The expression of CYP3A and CYP3A4 
may vary by as much as 40 fold due to genetic polymorphism.  Metabolites include 
phenylcyclohexylglycolic acid, which is pharmacologically inactive, and N-desethyloxybutynin, 
which is pharmacologically active.  Transdermal administration of oxybutynin bypasses the first-pass 
gastrointestinal and hepatic metabolism, reducing the formation of the N-desethyl metabolite.  
 
Excretion 
 
Oxybutynin is extensively metabolised by the liver, see above, with less than 0.1% of the administered 
dose excreted unchanged in the urine.  Also, less than 0.1% of the administered dose is excreted as the 
metabolite N-desethyloxybutynin. 
 
Person-to-person transference 
 
The potential for dermal transfer of oxybutynin from a treated person to an untreated person was 
evaluated in a single-dose study where subjects dosed with Kentera engaged in vigorous contact with 
an untreated partner for 15 minutes, either with (N=14 couples) or without (N=12 couples) clothing 
covering the application area.  The untreated partners not protected by clothing demonstrated 
detectable plasma concentrations of oxybutynin (mean Cmax = 0.94 ng/ml).  Two of the 14 untreated 
subjects participating in the clothing-to-skin contact regimen had measurable oxybutynin plasma 
concentrations (Cmax  < 0.1 ng/ml) during the 48 hours following contact with treated subjects; 
oxybutynin was not detectable with the remaining 12 untreated subjects. 
 
Effects of showering 
 
The effect of showering on the absorption of oxybutynin was evaluated in a randomised, steady-state 
crossover study under conditions of no shower, or showering 1, 2 or 6 hours after Kentera application 
(N=20).  The results of the study indicate that showering after one hour does not affect the overall 
systemic exposure to oxybutynin. 
 
Use with sunscreen 
 
The effect of sunscreen on the absorption of oxybutynin when applied 30 minutes before or 30 
minutes after Kentera application was evaluated in a single-dose randomised crossover study (N=16).  
Concomitant application of sunscreen, either before or after Kentera application, had no effect on the 
systemic exposure of oxybutynin. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on studies for acute toxicity, repeat dose 
toxicity, genotoxicity, carcinogenicity and local toxicity.  Adverse reactions were observed in 
embryotoxicity studies in the rabbit.  At a concentration of 0.4 mg/kg/day oxybutynin administered 
subcutaneously, the occurrence of organ anomalies is significantly increased, but is observed only in 
the presence of maternal toxicity.  However, in the absence of understanding the association between 
maternal toxicity and developmental effect, the relevance to human safety cannot be addressed.  In the 



 29 

subcutaneous fertility study in rats, while no effects were reported in males, in females, fertility was 
impaired and a NOAEL (no observed adverse effect level) of 5 mg/kg was identified. 
 
Environmental Risk Assessment 
The active substance oxybutynin is persistent in the environment. 
 
 
6 PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Ethanol (96 per cent) 
Glycerol 
Hydroxypropylcellulose 
Sodium hydroxide (for pH-adjustment) 
Purified water 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
2 years. 
 
6.4 Special precautions for storage 
 
Do not refrigerate or freeze.  Store pump in the upright position. 
 
Kentera contains alcohol and is considered flammable and should not come in contact with an open 
flame. 
 
6.5 Nature and contents of container 
 
The multidose container is comprised of an outer polypropylene bottle with a Low Density 
Polyethylene (LDPE) pouch liner, a polypropylene metering pump, with ethylene propylene diene 
monomer (EPDM) gaskets, and a polypropylene cap. 
 
Each multidose container contains at least 30 grams of Kentera and dispenses 30 metered 1 gram 
doses. 
 
Kentera is packaged in a carton containing 1 multidose container with metering pump. 
 
6.6 Special precautions for disposal and other handling 
 
Before using the pump for the first time the multidose container should be primed.  To prime the 
pump, fully depress the pump mechanism repeatedly until gel is observed, then depress the pump one 
more time, and discard this portion of the medicinal product to assure precise dose delivery.  The 
pump is now primed and ready for use. After the priming step is complete, 30 full doses will remain 
in the pump.  The metered dose should be applied immediately. 
 
Always place the small protective cap back firmly on the tip of the pump nozzle and the large pump 
cover over the top of the pump after each use.  If prime is lost during the use (no gel is dispensed after 
depressing the pump), repeat as instructed above to re-prime the pump. 
 
After applying the gel, hands should immediately be washed thoroughly with soap and water.  It is 
recommended to cover the application site with clothing once the gel has dried.  Avoid bathing, 



 30 

swimming, showering, exercising or immersing the application site in water for one hour after 
application. 
 
Empty multidose container must be discarded in accordance with local requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031 GA Haarlem 
The Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/03/270/005 1 multidose container with metering pump 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 15/06/2004 
Date of latest renewal: 30/04/2009 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu 
 
 
  

http://www.ema.europa.eu/


 31 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH 
RELEASE 

 
B. CONDITIONS OF THE MARKETING AUTHORISATION 

 



 32 

A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH 
RELEASE 

 
Name and address of the manufacturer(s) responsible for batch release  
 
Kentera gel and gel in sachet: 
 
Nicobrand Limited 
189 Castleroe Road 
Coleraine 
BT51 3RP 
Northern Ireland 
 
Teva Pharmaceuticals Europe B.V. 
Swensweg 5 
2031 GA Haarlem  
The Netherlands 
 
Kentera transdermal patch: 
 
Merckle GmbH 
Ludwig-Merckle-Straße 3 
89143 Blaubeuren 
Germany 
 
Teva Pharmaceuticals Europe B.V. 
Swensweg 5 
2031 GA Haarlem  
The Netherlands 
 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B CONDITIONS OF THE MARKETING AUTHORISATION 
 
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON 

THE MARKETING AUTHORISATION HOLDER 
 
Medicinal product subject to medical prescription. 
 
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
Not applicable. 
 
• OTHER CONDITIONS 
 
 
Pharmacovigilance System: 
 
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the 
Marketing Authorisation, is in place and functioning before and whilst the product is on the market. 
  



 33 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



 34 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



 35 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
CARTON (Containing 2, 8 and 24 transdermal patches) 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Kentera 3.9 mg / 24 hours transdermal patch 
oxybutynin 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each transdermal patch releases 3.9 mg of oxybutynin per 24 hours. Each patch of 39 cm2 contains 
36 mg of oxybutynin. 
 
 

3. LIST OF EXCIPIENTS 
 
Excipients: triacetin; acrylic adhesive (containing 2-ethylhexyl acrylate; N-vinyl pyrrolidone and 
hexamethyleneglycol dimethacrylate polymer domains). 
Backing: polyester/ethylene-vinyl acetate film; siliconised polyester film. 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
2 transdermal patches 
8 transdermal patches 
24 transdermal patches 
 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For transdermal use only. 
Do not use if seal on sachet is broken 
 
Apply immediately upon removal from sachet. 
Read the package leaflet before use. 
 
Sun/Wed  
Mon/Thu 
Tue/Fri 
Wed/Sat 
Thu/Sun 
Fri/Mon 
Sat/Tue 
 
Apply a new Kentera patch twice weekly (every 3 to 4 days). 
 
 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 
OUT OF THE REACH AND SIGHT OF CHILDREN 

 
Keep out of the reach and sight of children. 
 
 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 



 36 

 
 

8. EXPIRY DATE 
 
EXP: 
 
 

9. SPECIAL STORAGE CONDITIONS 
 
Do not refrigerate or freeze.  
 
 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031 GA Haarlem 
The Netherlands 
 
 

12. MARKETING AUTHORISATION NUMBER (S) 
 
EU/1/03/270/001 <8 transdermal patches> 
EU/1/03/270/002 <24 transdermal patches> 
EU/1/03/270/003 <2 transdermal patches> 
 
 

13. BATCH NUMBER 
 
Lot: 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
kentera 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



 37 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN: 
NN:  
 
 
  



 38 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SACHET (Contains 1 transdermal patch) 

 
 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Kentera 3.9 mg / 24 hours transdermal patch 
oxybutynin 
For transdermal use only. 
 

2. METHOD OF ADMINISTRATION 
 
 
Apply immediately upon removal from sachet. 
Read the package leaflet before use. 
 
 

3. EXPIRY DATE 
 
EXP:  
 
 

4. BATCH NUMBER 
 
Lot:  
 
 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
Contains 1 transdermal patch. 
 
 

6. OTHER 
 
Do not refrigerate or freeze.   
  



 39 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
CARTON ( Containing 30 sachets) 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Kentera 90.7 mg/g gel in sachet 
oxybutynin  
 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each sachet of 1 gram of gel contains 90.7 mg of oxybutynin (as hydrochloride) resulting in a nominal 
delivery of approximately 4 mg/day. 
 
 

3. LIST OF EXCIPIENTS 
 
Excipients: ethanol (96%), glycerol, hydroxypropylcellulose, sodium hydroxide (for pH adjustment), 
and purified water. 
 
See leaflet for further information. 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
Gel 
 
30 sachets of 1 gram. 
 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Apply immediately upon opening. 
 
Read package leaflet before use. 
 
Cutaneous use only. 
 
 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 
OUT OF THE REACH AND SIGHT OF CHILDREN 

 
Keep out of the reach and sight of children. 
 
 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 

8. EXPIRY DATE 
 
EXP 
 
 



 40 

9. SPECIAL STORAGE CONDITIONS 
 
Do not refrigerate or freeze. 
 
 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031 GA Haarlem 
The Netherlands 
 
 

12. MARKETING AUTHORISATION NUMBER (S) 
 
EU/1/03/270/004 <30 sachets> 
 

13. BATCH NUMBER 
 
Lot  
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
kentera gel 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN: 
NN:  
 
  



 41 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SACHET LABELLING 

 
 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Kentera 90.7 mg/g gel in  sachet 
oxybutynin  
Cutaneous use  
 
 

2. METHOD OF ADMINISTRATION 
 
Read leaflet before use. 
 
 

3. EXPIRY DATE 
 
EXP 
 
 

4. BATCH NUMBER 
 
Lot  
 
 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 gram  
 
 

6. OTHER 
 
 
  



 42 

PARTICULARS TO APPEAR ON THE OUTER AND THE IMMEDIATE  PACKAGING 
MULTIDOSE CONTAINER WITH METERING PUMP 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Kentera 90.7 mg/g gel 
oxybutynin  
 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each metered dose of 1 gram of gel contains 90.7 mg oxybutynin (as hydrochloride) resulting in a 
nominal delivery of approximately 4 mg/day. 
 
 

3. LIST OF EXCIPIENTS 
 
Excipients: ethanol (96%), glycerol, hydroxypropylcellulose, sodium hydroxide (for pH adjustment), 
and purified water. 
   
See leaflet for further information. 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
Gel 
 
1 multidose container with metering pump of 30 grams 
 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Apply immediately after gel is dispensed from the pump. 
 
Read package leaflet before use. 
 
Cutaneous use only. 
 
 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 
OUT OF THE REACH AND SIGHT OF CHILDREN 

 
Keep out of the reach and sight of children. 
 
 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 

8. EXPIRY DATE 
 
EXP 
 
 



 43 

9. SPECIAL STORAGE CONDITIONS 
 
Do not refrigerate or freeze.  Store pump in the upright position. 
 
 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031 GA Haarlem 
The Netherlands 
 
 

12. MARKETING AUTHORISATION NUMBER (S) 
 
EU/1/03/270/005 <1 multidose container with metering pump> 
 
 

13. BATCH NUMBER 
 
Lot  
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
kentera gel  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN: 
NN:  
 
  



 44 

 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 
 
 
 
  



 45 

PACKAGE LEAFLET: INFORMATION FOR THE USER 
 

Kentera 3.9 mg / 24 hours transdermal patch 
Oxybutynin 

 
 
Read all of this leaflet carefully before you start using Kentera. 
 
- Keep this leaflet. You may need to read it again. 
- If you have further questions, please ask your doctor or your pharmacist. 
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their 

symptoms are the same as yours. 
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell 

your doctor or pharmacist.  See section 4. 
 
In this leaflet: 
 
1. What Kentera is and what it is used for 
2. Before you use Kentera 
3. How to use Kentera 
4. Possible side effects 
5. How to store Kentera 
6. Further Information 
 
 
1. WHAT KENTERA IS AND WHAT IT IS USED FOR 
 
Kentera is used in adults to control the symptoms of urge incontinence and/or increased urinary 
frequency and urgency. 
 
Kentera works by allowing the bladder to expand and accommodate more urine. 
 
 
2. BEFORE YOU USE KENTERA 
 
Do not use Kentera: 
 
- If you are hypersensitive (allergic) to oxybutynin or any of the ingredients of Kentera. 
- If you have a rare condition called myasthenia gravis that makes the muscles in the body 

become weak and tire easily. 
- If you experience incomplete bladder emptying during urination, the use of oxybutynin may 

increase this problem. You should discuss this problem with your doctor before using Kentera. 
- If you have digestion problems caused by reduced emptying of the stomach after a meal you 

should consult your doctor before using Kentera. 
- If you have glaucoma or a family history of glaucoma, tell your doctor. 
 
Take special care with Kentera: 
 
If you have any of the following: 
- Liver problems 
- Kidney problems 
- Difficulty urinating 
- Intestinal blockage 
- Bloody stools 
- Generalized muscle weakness 
- Painful swallowing 
 



 46 

Since treatment with oxybutynin may cause decreased perspiration, there is an increased risk of fever 
and heat stroke if you are exposed to high environmental temperatures. 
 
Kentera is not recommended for use in children or adolescents. 
 
Taking other medicines 
 
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, 
including medicines obtained without a prescription. 
 
Applying the Kentera patch at the same time as taking other medicines that have similar side effects 
such as dry mouth, constipation and drowsiness, may increase how often and how severe these side 
effects are experienced.   
 
Oxybutynin may slow the digestive tract and thereby influence the adsorption of other oral medicines, 
or the use of this medicine together with other medicines may increase the effect of oxybutynin. 
Especially: 
- Ketoconasole, itraconazole or fluconazole (used for the treatment of fungal infections).  
- Erythromycin a macrolide antibiotic (used to treat bacterial infections). 
- Biperiden, levodopa, or amantadine (used to treat Parkinson’s disease). 
- Antihistamines (used in the treatment of allergies such as hayfever). 
- Phenothiazines or clozapine (used to treat mental illness). 
- Tricyclic antidepressants (used to treat depression). 
- Dipyridamole (used to treat blood clotting problems). 
- Atropine and other anticholinergic medicines (used for treatment in stomach disorders such as 

irritable bowel syndrome). 
 
Using Kentera with food and drink 
 
Oxybutynin may cause drowsiness or blurred vision. Drowsiness may be increased by consumption of 
alcohol. 
 
Pregnancy and breast-feeding 
 
Ask your doctor for advice before taking any medicine. 
 
Kentera should not be used during pregnancy unless clearly necessary. 
 
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. 
 
Driving and using machines 
 
Because Kentera may produce drowsiness, somnolence, or blurred vision, patients should be advised 
to exercise caution when driving or using machinery. 
 
 
3. HOW TO USE KENTERA 
 
Always use Kentera exactly as your doctor has instructed you. You should check with your doctor or 
pharmacist if you are not sure. 
 
Apply a new Kentera patch twice weekly (every 3 to 4 days) according to the instructions for use. 
Change the patch on the same two days every week, for example, every Sunday and Wednesday or 
Monday and Thursday. Printed on the inside flap of your Kentera package, you will find a Kentera 
calendar checklist that will help you to remember your dosing schedule. Mark the schedule you plan to 
follow and remember always to change your patch on the same two days of the week you have chosen 



 47 

on your calendar. Make sure to wear only one patch at a time and wear your patch continuously, until 
it is time to apply a new one. 
 
Where to apply 
 
Apply the patch to a clean, dry, smooth area of skin on your abdomen, hips or buttocks. Avoid placing 
the patch in the waistline area to prevent tight clothing from rubbing against the patch. Do not expose 
the patch to the sun. Place the patch underneath your clothing. Rotate application sites with each new 
application. Do not apply a patch to the same place on your body for at least 1 week. 
 
 
 
 
 
 
 
 
 
 
How to apply 
 
Each patch is individually sealed in a protective sachet. Please read all the information below before 
you begin to apply Kentera. 
 
To apply Kentera: 
 
Step 1: Choose a spot for the patch that is: 
 
- Freshly washed, but dry and cool (wait a few minutes after taking a hot bath or shower). 
- Free of body powder, lotion, and oil. 
- Free of cuts, rashes or any other skin irritation. 

 
Step 2: Open the sachet that contains the patch. 
 
- Tear open along arrows marked on the right side of the sachet as shown in drawing below. 
- Do not cut the sachet with scissors, which might damage the patch inside. 
- Pull the patch out. 
- Apply immediately to your skin; do not keep or store the patch outside the sealed sachet. 
 

 
 
Step 3: Apply one half of the patch to your skin. 
 
- Gently bend the patch and remove the first piece of protective liner, which covers the sticky 

surface of the patch. 
- Without touching the sticky surface, firmly press the patch, adhesive face down, onto the part of 

the abdomen, hips or buttocks you have selected for application. 
 



 48 

 
 
Step 4: Apply the second half of the patch to your skin. 
 
- Bend the patch back over itself. Press down on the liner firmly. 
- Push the liner forward a little to loosen the edge. 
- Grab the loose edge at either corner and peel off the second piece of the liner. Try not to touch 

the sticky surface of the patch. 
- Press the entire patch firmly onto the skin with your fingertips. Press for at least 10 seconds to 

make sure the patch will stay in place. Be sure all of it sticks to your skin, even around the 
edges. 

- Discard the protective liners. 
 

 
 
Bathing, showering, swimming and exercise: 
 
You should wear each patch all the time until you apply a new one. Baths, showers, swimming and 
exercise should not affect the patch as long as you don’t rub the patch as you wash. Avoid soaking in a 
hot bath for a long period of time, which can make the patch come off. 
 
If the patch comes off: 
 
If the patch starts to lift off your skin, apply a little bit of pressure using your fingertips. The patch is 
designed to re-stick. Very rarely will the patch come off completely. If it does, try putting the same 
patch back on the same spot. If it sticks firmly all over, leave it on. If not, take it off and put a new 
patch on a new spot. No matter what day this happens, continue with the twice-a-week schedule that 
you have marked on your patch box. 
 
If you forget to change the patch after 3-4 days: 
 
As soon as you remember, remove the old patch and apply a new one to a new spot on your abdomen, 
hips or buttocks. No matter what day this happens, continue with the same twice-a-week schedule for 
your next patch, even if it means changing the new patch before 3 to 4 days have elapsed. 
 
How to remove 
 
When changing the patch, remove the old patch slowly. Fold it in half (sticky sides together) and 
throw it away to keep out of the reach of children and pets. Mild redness may be present at the 
application site. This redness should disappear within several hours after removal of the patch. If 
irritation persists, please contact your doctor. 
 
Gently washing the application site with warm water and a mild soap should remove any adhesive that 
remains on your skin after removal of the patch. A small amount of baby oil may also be used to 
remove any excess residue. Rings of adhesive that become soiled may require a medical adhesive 
removal pad that should be available from your pharmacist. Alcohol or other strong solvents may 
cause skin irritation and should not be used. 



 49 

 
After use the patch still contains substantial quantities of active ingredients. Remaining active 
ingredients of the patch may have harmful effects if reaching the aquatic environment. Hence, after 
removal, the used patch should be folded in half, adhesive side inwards so that the release membrane is 
not exposed, placed in the original sachet and then discarded safely out of reach of children. Any used 
or unused patches should be discarded according to local requirements or returned to the pharmacy. 
Used patches should not be flushed down the toilet nor placed in liquid waste disposal systems. 
 
If you use more Kentera than you should 
 
The patient should not apply more than one patch at a time.  
 
If you forget to use Kentera 
 
Apply a Kentera patch as soon as you realise your patch is missing, or you have missed a scheduled day 
of application. 
 
If you stop using Kentera 
 
Your urge incontinence may return and you may have increased urinary frequency if you decide to stop 
using the patch. Continue to use Kentera as long as your doctor tells you to. 
 
Talk to your doctor or pharmacist if you have any questions on the use of this medical product. 
 
 
4.  POSSIBLE SIDE EFFECTS 
 
Like all medicines, Kentera can cause side effects, although not everybody gets them. 
 
The frequency of possible side effects listed below is defined using the following convention: 
- Very common (affects more than 1 user in 10) 
- Common (affects 1 to 10 users in 100) 
- Uncommon (affects 1 to 10 users in 1,000) 
- Rare (affects 1 to 10 users in 10,000) 
- Very rare (affects less than 1 user in 10,000) 
- Not known (frequency cannot be estimated from the available data) 
 
Very common side effect:  
- itching around the site of patch application  
 
Common side effects: 
- redness or rash at the site of patch application 
- dry mouth 
- constipation 
- diarrhoea 
- upset stomach 
- stomach pain 
- headache or sleepiness 
- urinary tract infections 
- blurred vision 
- dizziness 
 
Uncommon side effects:  
- upper respiratory tract or fungal infections 
- anxiety  
- confusion  



 50 

- nervousness  
- agitation  
- difficulty in sleeping 
- palpitations 

- hot flushes 
- back pain 
- urinary retention 
- difficulty urinating 
- common cold 
- accidental injury 

 
Rare side effects 
- panic reaction 
- mental confusion 
- hallucinations 
- disorientation 
- memory impairment 
- loss of memory 
- abnormal tiredness 
- poor concentration 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. STORING KENTERA 
 
Keep out of the reach and sight of children. 
 
Do not use Kentera after the date shown on the sachet and the carton. 
 
Do not refrigerate or freeze. 
 
The used patches should be folded in half, adhesive side inwards so that the release membrane is not 
exposed, placed in the original sachet and then discarded safely out of the reach of children. Any used 
or unused patches should be discarded according to local requirements or returned to the pharmacy. 
Used patches should not be flushed down the toilet nor placed in liquid waste disposal systems. 
 
 
6. FURTHER INFORMATION 
 
What Kentera contains 
 
The active substance is oxybutynin. Each transdermal patch releases 3.9 mg of oxybutynin per 
24 hours. Each patch of 39 cm2 contains 36 mg of oxybutynin. 
 
The other ingredients are: Each patch contains triacetin, and acrylic adhesive solution. The 
oxybutynin, triacetin and acrylic adhesive are coated on clear PET/EVA backing film and covered 
with a siliconised polyester release liner. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 51 

What Kentera looks like and contents of the pack 
 
Kentera is a transdermal patch and it is packaged in cartons containing 2, 8, and 24 patches. Each 
patch consists of a clear backing film that has the pharmaceutical ingredients coated on the side 
containing the protective backing film. The backing film is to be removed prior to patch application. 
 
Marketing Authorisation Holder 
 
Teva B.V. 
Swensweg 5 
2031 GA Haarlem 
The Netherlands 
 
Manufacturer 
 
Teva Pharmaceuticals Europe B.V. 
Swensweg 5 
2031 GA Haarlem  
The Netherlands 
 
Merckle GmbH 
Ludwig-Merckle-Straße 3 
89143 Blaubeuren 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder.  
 

België/Belgique/Belgien 
Eurocept BV 
Tél/Tel: +31 (0) 35 528 8377 
 

Lietuva 
UAB Teva Baltics 
Tel: +370 5 266 02 03 
 

България 
Actavis EAD 
Tel: +359 2 489 95 85 
 

Luxembourg/Luxemburg 
Eurocept BV 
Tél/Tel: +31 (0) 35 528 8377 
 

Česká republika 
Teva Pharmaceuticals CR, s.r.o.  
Tel: +420 251 007 111 
 

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel: (+36) 1 288 6400 
 

Danmark 
Recordati AB 
Sverige 
Tlf: +46 8 545 80 230 
infoNordic@recordati.com 
 

Malta 
V.J. Salomone Pharma Ltd 
Tel: +35 621 220 174 
 

Deutschland 
Recordati Pharma GmbH 
Tel: +49 (0) 731 7047 0 
 

Nederland  
Eurocept BV 
Tel: +31 (0) 35 528 8377 
 

Eesti 
UAB Teva Baltics Eesti filiaal 
Tel: +372 661 0801 
 

Norge 
Recordati AB 
Sverige 
Tlf: +46 8 545 80 230 
infoNordic@recordati.com 
 



 52 

Ελλάδα 
Recordati Hellas Pharmaceuticals A.E. 
Τηλ: +30 210-6773822 
 

Österreich 
Haemo- Pharma Consult GmbH 
Tel: +43 (0) 2689 3116 0 
 

España 
Laboratorios Gebro Pharma, S.A. 
Tel: +34 93 205 86 86 
 

Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel: +48 22 345 93 00 
 

France 
Teva Santé 
Tél: +33 1 55 91 78 00 
 

Portugal  
Jaba Recordati S.A. 
Tel: +351 21 4329 500 
 

Hrvatska 
Pliva Hrvatska d.o.o. 
Tel: + 385 1 37 20 000 
 

România 
Teva Pharmaceuticals S.R.L. 
Tel: +4021 230 65 24 
 

Ireland 
Recordati Ireland Ltd. 
Tel: +353 (0) 21 4379400 
 

Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 1 58 90 390 
 

Ísland 
Actavis Pharmaceuticals Iceland ehf. 
Sími: + 354 550 3300 
 

Slovenská republika 
Herbacos Recordati s.r.o. 
Česká republika 
Tel: +420 466 741 915 
 

Italia 
Innova Pharma S.p.A. 
Tel: +39 02 48787.1 
 

Suomi/Finland 
Recordati AB 
Ruotsi/Sverige 
Puh/Tel: +46 8 545 80 230 
infoNordic@recordati.com 
 

Κύπρος 
Recordati Hellas Pharmaceuticals A.E. 
Ελλάδα 
Τηλ: +30 210-6773822 
 

Sverige 
Recordati AB 
Tel: +46 8 545 80 230 
infoNordic@recordati.com 
 

Latvija 
UAB Teva Baltics filiāle Latvijā 
Tel: +371 67 323 666 
 

United Kingdom 
Orion Pharma (UK) Ltd 
Tel: +44 (0) 1635 520300 
 

 
This leaflet was approved in 
 
Detailed information on this medicine is available on the European Medicines Agency (EMA) web 
site: http://www.ema.europa.eu 
 
  

http://www.ema.europa.eu/


 53 

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

 
Kentera 90.7 mg/g gel in sachet  

Oxybutynin 
 

 
Read all of this leaflet carefully before you start using Kentera 
 
-  Keep this leaflet. You may need to read it again. 
-  If you have further questions, please ask your doctor or your pharmacist. 
-  This medicine has been prescribed for you. Do not pass it on to others.  It may harm them even 

if their symptoms are the same as yours. 
-  If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, 

please tell your doctor or pharmacist.  See section 4. 
 
In this leaflet: 
 
1. What Kentera is and what it is used for 
2. Before you use Kentera 
3. How to use Kentera 
4. Possible side effects 
5. How to store Kentera 
6. Further information 
 
 
3. WHAT KENTERA IS AND WHAT IT IS USED FOR 
 
Kentera contains the active substance oxybutynin and is used in adults to control the symptoms of urge 
incontinence and/or increased urinary frequency and urgency. 
 
Kentera works by allowing the bladder to expand and accommodate more urine. 
 
 
4. BEFORE YOU USE KENTERA 
 
Do not use Kentera 
 
- If you are hypersensitive (allergic) to oxybutynin or any of the ingredients of Kentera. 
- If you have a rare condition called myasthenia gravis that makes the muscles in the body 

become weak and tire easily. 
- If you have glaucoma or a family history of glaucoma, tell your doctor. 
- If you have difficulty emptying your bladder. 
- If you are unable to have complete bowel movements. 
 
Take special care with Kentera 
 
If you have any of the following: 
- Liver problems; 
- Kidney problems; 
- Difficulty urinating; 
- Intestinal blockage; 
- Bloody stools; 
- Generalised muscle weakness; 
- Painful swallowing; 
- Unable to empty bladder during urination; 
- Retained food in stomach after meals; 



 54 

- Are above 65 years old; 
- Chronic dry mouth that has resulted in periodontal disease or oral fungal infections; 
- Nerve disorder that affects involuntary body functions including heart rate, blood pressure, 

perspiration and digestion; 
- Problems with memory, language, or thinking abilities; 
- A progressive neurological disease characterised by tremor of resting muscles, rigidity, 

slowness of movement, impaired balance, and a shuffling gait; 
- Overactive thyroid gland which can cause increased appetite, weight loss, or sweating; 
- Narrowing of the blood vessels that supply blood and oxygen to the heart; 
- Heart problems which can cause shortness of breath or ankle swelling; 
- Irregular heart beat; 
- Faster heart beat; 
- High blood pressure; 
- Enlarged prostate. 

 
Since treatment with oxybutynin may cause decreased perspiration, there is an increased risk of fever 
and heat stroke if you are exposed to high environmental temperatures. 
 
Children and adolescents 
 
Kentera is not recommended for use in children and adolescents under 18 years old. 
 
Using other medicines 
 
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, 
including medicines obtained without a prescription. 
 
Applying Kentera while taking other medicines that have similar side effects, such as dry mouth, 
constipation, and drowsiness, may increase how often and how severe these side effects are 
experienced.   
 
Oxybutynin may slow the digestive tract and thereby influence the adsorption of other oral medicines, 
interfere with bowel movement therapies, and the use of this medicine together with other medicines 
may increase the effect of oxybutynin. Especially: 
- Ketoconazole, itraconazole or fluconazole (used for the treatment of fungal infections).  
- Erythromycin a macrolide antibiotic (used to treat bacterial infections). 
- Biperiden, levodopa, or amantadine (used to treat Parkinson’s disease). 
- Antihistamines (used in the treatment of allergies such as hayfever). 
- Phenothiazines, butyrophenone or clozapine (used to treat mental illness). 
- Tricyclic antidepressants (used to treat depression). 
- Quinidine (used to treat abnormal heart rhythms). 
- Dipyridamole (used to treat blood clotting problems). 
- Atropine and other anticholinergic medicines (used in the treatment of stomach disorders such 

as irritable bowel syndrome). 
 
Using Kentera with food and drink 
 
Oxybutynin may cause drowsiness or blurred vision. Drowsiness may be increased by consumption of 
alcohol. 
 
Pregnancy and breast-feeding 
 
Ask your doctor for advice before taking any medicine. 
 
Talk to your doctor before using Kentera if you are pregnant, might be pregnant or are planning to 
become pregnant. You should not use Kentera if you are pregnant unless your doctor has told you to. 
 



 55 

If you are a woman of childbearing age, you should be tested for pregnancy before using Kentera.  
You should use some form of pregnancy contraceptive while using Kentera. 
 
A small amount of orally administered oxybutynin is excreted in the mother’s milk. Use of oxybutynin 
while breast-feeding is therefore not recommended. 
 
Keep application sites covered with clothing when coming into contact with breast-feeding women or 
nursing babies. 
 
Driving and using machines 
 
Kentera may produce drowsiness, sleepiness, or blurred vision.  Take special care when driving or 
using machinery. 
 
 
3. HOW TO USE KENTERA 
 
Always use Kentera exactly as your doctor has told you.  You should check with your doctor or 
pharmacist if you are not sure. 
 
The usual dose is one sachet applied once daily to dry, intact skin on the abdomen, upper 
arms/shoulders, or thighs, which delivers 4 mg of oxybutynin in 24 hours.   
 
Important:  Kentera is for application to the skin only.  Kentera must not be taken by mouth.  Avoid 
contact with eyes, nose, open sores, recently shaved skin, and skin with rashes or other areas not 
approved for the application of Kentera. 
 
Step 1. The approved application sites for Kentera are the shaded areas shown in Figure A.  These are 

the abdomen (stomach area), upper arms/shoulder, and thigh. 
Select an approved site for the application of Kentera.  Only apply Kentera to intact skin. 
Application sites should be rotated. You should not apply Kentera to the same site on 
consecutive days.  Rotating approved application sites with each dose may help in reducing 
the risk of developing skin irritations.  Do not apply Kentera in an area that is not approved.  
 
 
Figure A: 

 
 
  
Step 2. Wash your hands with soap and water before applying Kentera. 

 
Step 3. Wash the area where Kentera will be applied with mild soap and water.  

Allow the area to dry completely. 
 

Step 4. Gently rub Kentera into your skin until it dries. 



 56 

Do not continue rubbing after Kentera has dried.  If applying Kentera to the stomach, care 
should be taken to avoid the area around the navel (belly button). See Figure B.  
 
 
Figure B: 

 
 

Step 5. After applying Kentera, immediately wash your hands thoroughly with soap and water.  
Avoid bathing, swimming, showering, exercising or immersing the application site in water 
for one hour after application. 
The application site may be covered with clothing once Kentera has dried. 
 

How to use the sachets: 
 
Step 1. Tear the sachet open at the indentation just before use.  See Figure C.   

 
 
 
 
 
 

Figure C: 

 
Squeeze the entire contents of the sachet onto your hand (palm or fingertips) or squeeze directly onto 
the application site. (See Figure D). 
   
Squeeze from the bottom of the sachet toward the open end. Repeat until the sachet is empty. The 
amount of gel in each sachet will be about the size of a small coin (20 mm in diameter) on your skin. 
 



 57 

Figure D: 
 

 
 

Step 2. Carefully throw away the open sachet so that children and pets are not exposed to it. 
 
If you use more Kentera than you should 
You should not apply more than one sachet during a 24 hour period.   
 
If you forget to use Kentera 
Apply a single dose as soon as you realise you have missed an application. 
 
If you stop using Kentera 
Your urge incontinence may return and you may have increased urinary frequency if you decide to stop 
using the gel. Continue to use Kentera as long as your doctor tells you to. 
 
Talk to your doctor or pharmacist if you have any questions on the use of this medicine. 
 
 
4.  POSSIBLE SIDE EFFECTS 
 
Like all medicines Kentera can cause side effects, although not everybody gets them. 
 
The frequency of possible side effects listed below is defined using the following convention: 
- Very common (affects more than 1 user in 10) 
- Common (affects 1 to 10 users in 100) 
- Uncommon (affects 1 to 10 users in 1,000) 
- Rare (affects 1 to 10 users in 10,000) 
- Very rare (affects less than 1 user in 10,000) 
- Not known (frequency cannot be estimated from the available data) 

 
Common side effects 
- headache 
- dizziness 
- dry mouth 
- constipation 
- itchiness 
- itchiness, inflammation, or pain at the application site 

 
Uncommon side effects  
- bladder infection 
- anxiety  
- confusion  
- nervousness  
- agitation  
- difficulty in sleeping 
- low blood levels of potassium which can cause muscle weakness, twitching or abnormal heart 

rhythm 



 58 

- feeling worried 
- sleepiness, drowsy 
- after taste, taste changed, abnormal sense of taste (i.e. metallic taste in mouth) 
- not sleeping well 
- shaking 
- eyes feel sticky, gritty 
- a feeling of dizziness or spinning 
- irregular heart beat 
- rapid irregular heart beat 
- skin is markedly red 
- cough 
- increased mucous, phlegm 
- loose or watery stools 
- feeling sick, queasy 
- indigestion, heartburn 
- throwing up 
- swelling of blood vessels around the anus 
- rash 
- dry skin 
- itchy rash 
- painful or difficulty urinating 
- blood in urine 
- kidney pain 
- delayed or slow start of urinary flow 
- tiredness, exhaustion 
- swelling of ankles, feet or fingers 
- small bumps at application site 
- numbness at application site 
- redness at application site 
- irritation at application site 
- pain at application site 
- pus filled bumps at application site 
- abnormal electrocardiogram (ECG or EKG, test of heart) 
- change in ECG or EKG 
- high chloride levels in blood 
 
Rare side effects 
- panic reaction 
- mental confusion 
- hallucinations 
- disorientation 
- memory impairment 
- loss of memory 
- abnormal tiredness 
- poor concentration 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. HOW TO STORE KENTERA  
 
Keep out of the reach and sight of children. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 59 

Do not use Kentera after the expiry date which is stated on the sachet and the carton after EXP.  The 
expiry date refers to the last date of that month. 
 
Do not refrigerate or freeze. 
 
Kentera contains alcohol and is considered flammable. The product should not come in contact with 
an open flame. 
 
Apply immediately after opening the sachet.  Discard empty sachets and unused product in accordance 
with local requirements. 
 
 
6. FURTHER INFORMATION 
 
What Kentera contains 
 
- The active substance is oxybutynin. Each sachet of 1 gram of gel contains 90.7 mg of 

oxybutynin resulting in a nominal delivery of approximately 4 mg/day.   
 
- The other ingredients are: ethanol (96%), glycerol, hydroxypropylcellulose, sodium hydroxide 

(for pH adjustment), and purified water. 
 
What Kentera looks like and contents of the pack 
 
Kentera is a rapid drying, clear, smooth, odourless, and colourless hydroalcoholic gel that is packaged 
in single dose sachets.  Each sachet contains 1 g of gel.  Each carton contains 30 sachets. 
 
The sachet is constructed from a multi-layer foil based laminated pouch material. 
 
Marketing Authorisation Holder 
 
Teva B.V. 
Swensweg 5 
2031 GA Haarlem 
The Netherlands 
 
Manufacturer 
 
Nicobrand Limited  
189 Castleroe Road 
Coleraine  
Northern Ireland 
BT51 3RP 
 
Teva Pharmaceuticals Europe B.V. 
Swensweg 5 
2031 GA Haarlem  
The Netherlands 
 
This leaflet was last approved in  
 
Detailed information on this medicine is available on the European Medicines Agency 
web site: http://www.ema.europa.eu 
 
  

http://www.ema.europa.eu/


 60 

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

 
Kentera 90.7 mg/g gel 

Oxybutynin  
 

 
Read all of this leaflet carefully before you start using Kentera 
 
-  Keep this leaflet. You may need to read it again. 
-  If you have further questions, please ask your doctor or your pharmacist. 
-  This medicine has been prescribed for you. Do not pass it on to others.  It may harm them even 

if their symptoms are the same as yours. 
-  If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, 

please tell your doctor or pharmacist.  See section 4. 
 
In this leaflet: 
 
1. What Kentera is and what it is used for 
2. Before you use Kentera 
3. How to use Kentera 
4. Possible side effects 
5. How to store Kentera 
6. Further information 
 
 
1. WHAT KENTERA IS AND WHAT IT IS USED FOR 
 
Kentera contains the active substance oxybutynin and is used in adults to control the symptoms of urge 
incontinence and/or increased urinary frequency and urgency. 
 
Kentera works by allowing the bladder to expand and accommodate more urine. 
 
 
2. BEFORE YOU USE KENTERA 
 
Do not use Kentera 
 
- If you are hypersensitive (allergic) to oxybutynin or any of the ingredients of Kentera. 
- If you have a rare condition called myasthenia gravis that makes the muscles in the body 

become weak and tire easily. 
- If you have glaucoma or a family history of glaucoma, tell your doctor. 
- If you have difficulty emptying your bladder. 
- If you are unable to have complete bowel movements. 
 
Take special care with Kentera 
 
If you have any of the following: 
- Liver problems 
- Kidney problems 
- Difficulty urinating 
- Intestinal blockage 
- Bloody stools 
- Generalised muscle weakness 
- Painful swallowing 
- Unable to empty bladder during urination 
- Retained food in stomach after meals 



 61 

- Are above 65 years old 
- Chronic dry mouth that has resulted in periodontal disease or oral fungal infections 
- Nerve disorder that affects involuntary body functions including heart rate, blood pressure, 

perspiration and digestion 
- Problems with memory, language, or thinking abilities 
- A progressive neurological disease characterised by tremor of resting muscles, rigidity, 

slowness of movement, impaired balance, and a shuffling gait. 
- Overactive thyroid gland which can cause increased appetite, weight loss, or sweating 
- Narrowing of the blood vessels that supply blood and oxygen to the heart 
- Heart problems which can cause shortness of breath or ankle swelling 
- Irregular heart beat 
- Faster heart beat 
- High blood pressure 
- Enlarged prostate 

 
Since treatment with oxybutynin may cause decreased perspiration, there is an increased risk of fever 
and heat stroke if you are exposed to high environmental temperatures. 
 
Children and adolescents 
 
Kentera is not recommended for use in children and adolescents under 18 years old. 
 
Using other medicines 
 
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, 
including medicines obtained without a prescription. 
 
Applying Kentera while taking other medicines that have similar side effects, such as dry mouth, 
constipation, and drowsiness, may increase how often and how severe these side effects are 
experienced.   
 
Oxybutynin may slow the digestive tract and thereby influence the adsorption of other oral medicines, 
interfere with bowel movement therapies, and the use of this medicine together with other medicines 
may increase the effect of oxybutynin. Especially: 
- Ketoconazole, itraconazole or fluconazole (used for the treatment of fungal infections).  
- Erythromycin a macrolide antibiotic (used to treat bacterial infections). 
- Biperiden, levodopa, or amantadine (used to treat Parkinson’s disease). 
- Antihistamines (used in the treatment of allergies such as hayfever). 
- Phenothiazines, butyrophenone or clozapine (used to treat mental illness). 
- Tricyclic antidepressants (used to treat depression). 
- Quinidine (used to treat abnormal heart rhythms). 
- Dipyridamole (used to treat blood clotting problems). 
- Atropine and other anticholinergic medicines (used in the treatment of stomach disorders such 

as irritable bowel syndrome). 
 
Using Kentera with food and drink 
 
Oxybutynin may cause drowsiness or blurred vision. Drowsiness may be increased by consumption of 
alcohol. 
 
Pregnancy and breast-feeding 
 
Ask your doctor for advice before taking any medicine. 
 
Talk to your doctor before using Kentera if you are pregnant, might be pregnant or are planning to 
become pregnant.  You should not use Kentera if you are pregnant unless your doctor has told you to. 
 



 62 

If you are a woman of childbearing age, you should be tested for pregnancy before using Kentera.  
You should use some form of pregnancy contraceptive while using Kentera. 
 
A small amount of orally administered oxybutynin is excreted in the mother’s milk. Use of oxybutynin 
while breast-feeding is therefore not recommended. 
 
Keep application sites covered with clothing when coming into contact with breast-feeding women or 
nursing babies. 
 
Driving and using machines 
 
Kentera may produce drowsiness, sleepiness, or blurred vision. Take special care when driving or 
using machinery. 
 
 
3. HOW TO USE KENTERA 
 
Always use Kentera exactly as your doctor has told you.  You should check with your doctor or 
pharmacist if you are not sure. 
 
The usual dose is the contents of one dispensed dose from the  multidose container with metering 
pump applied once daily to dry, intact skin on the abdomen, upper arms/shoulders, or thighs, which 
delivers 4 mg of oxybutynin in 24 hours.  
 
Important:  Kentera is for application to the skin only.  Kentera must not be taken by mouth.  Avoid 
contact with eyes, nose, open sores, recently shaved skin, and skin with rashes or other areas not 
approved for the application of Kentera. 
 
Step 1.  The approved application sites for Kentera are the shaded areas shown in Figure A.  These are 

the abdomen (stomach area), upper arms/shoulder, and thigh. 
Select an approved site for the application of Kentera.  Only apply Kentera to intact skin. 
Application sites should be rotated. You should not apply Kentera to the same site on 
consecutive days.  Rotating approved application sites with each dose may help in reducing 
the risk of developing skin irritations.  Do not apply Kentera in an area that is not approved.  
 
Figure A: 

 
  
Step 2.  Wash your hands with soap and water before applying Kentera. 

 
Step 3.  Wash the area where Kentera will be applied with mild soap and water.  

Allow the area to dry completely. 
 
Step 4.  Gently rub Kentera into your skin until it dries. 

Do not continue rubbing after Kentera has dried.  If applying Kentera to the stomach, care 
should be taken to avoid the area around the navel (belly button). See Figure B.  

 
 



 63 

Figure B: 
 

 
 

Step 5.  After applying Kentera, immediately wash your hands thoroughly with soap and water.  
Avoid bathing, swimming, showering, exercising or immersing the application site in water 
for one hour after application. 
The application site may be covered with clothing once Kentera has dried. 
 

How to use the multidose container with metering pump:  
 
It is important you read and follow these directions on how to use the Kentera pump properly.  
 
Step 1.  Before using the pump for the first time, you must prime the Kentera pump.  To prime the 

pump, fully depress the pump mechanism repeatedly until gel is observed, then depress the 
pump one more time, and discard this portion of the product to assure precise dose delivery.  
The pump is now primed and ready for use. After the priming step is complete, 30 full doses 
will remain in the pump.  

 
 
 
 
 
 
 
 
 

Step 2.  Fully depress the pump once onto your hand (palm or fingers), or directly onto the application 
site.  The amount of gel from one pump depression will be about the size of a small coin 
(20 mm in diameter) on your skin. Apply as directed above.  Always place the small 
protective cap back firmly on the tip of the pump nozzle and the large pump cover over the top 
of the pump after each use.  If prime is lost during the use (no gel is dispensed after depressing 
the pump), repeat as instructed above to re-prime the pump.  After 30 doses, discard the 
Kentera pump.  Kentera pump should be discarded in household trash in a manner that 
prevents accidental application or ingestion by household members or pets. 

 

 
 
If you use more Kentera than you should 
You should not apply more than a single metered dose during a 24 hour period.   
 



 64 

If you forget to use Kentera 
Apply a single dose as soon as you realise you have missed an application. 
 
If you stop using Kentera 
Your urge incontinence may return and you may have increased urinary frequency if you decide to stop 
using the gel. Continue to use Kentera as long as your doctor tells you to. 
 
Talk to your doctor or pharmacist if you have any questions on the use of this medicine. 
 
 
4.  POSSIBLE SIDE EFFECTS 
 
Like all medicines Kentera can cause side effects, although not everybody gets them. 
 
The frequency of possible side effects listed below is defined using the following convention: 
- Very common (affects more than 1 user in 10) 
- Common (affects 1 to 10 users in 100) 
- Uncommon (affects 1 to 10 users in 1,000) 
- Rare (affects 1 to 10 users in 10,000) 
- Very rare (affects less than 1 user in 10,000) 
- Not known (frequency cannot be estimated from the available data). 

 
Common side effects 
- headache 
- dizziness 
- dry mouth 
- constipation 
- itchiness 
- itchiness, inflammation, or pain at the application site 

 
Uncommon side effects  
- bladder infection 
- anxiety  
- confusion  
- nervousness  
- agitation  
- difficulty in sleeping 
- low blood levels of potassium which can cause muscle weakness, twitching or abnormal heart 

rhythm 
- feeling worried 
- sleepiness, drowsy 
- after taste, taste changed, abnormal sense of taste (i.e. metallic taste in mouth) 
- not sleeping well 
- shaking 
- eyes feel sticky, gritty 
- a feeling of dizziness or spinning 
- irregular heart beat 
- rapid irregular heart beat 
- skin is markedly red 
- cough 
- increased mucous, phlegm 
- loose or watery stools 
- feeling sick, queasy 
- indigestion, heartburn 
- throwing up 
- swelling of blood vessels around the anus 
- rash 



 65 

- dry skin 
- itchy rash 
- painful or difficulty urinating 
- blood in urine 
- kidney pain 
- delayed or slow start of urinary flow 
- tiredness, exhaustion 
- swelling of ankles, feet or fingers 
- small bumps at application site 
- numbness at application site 
- redness at application site 
- irritation at application site 
- pain at application site 
- pus filled bumps at application site 
- abnormal electrocardiogram (ECG or EKG,test of heart) 
- change in ECG or EKG 
- high chloride levels in blood 
 
Rare side effects 
- panic reaction 
- mental confusion 
- hallucinations 
- disorientation 
- memory impairment 
- loss of memory 
- abnormal tiredness 
- poor concentration 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. HOW TO STORE KENTERA 
 
Keep out of the reach and sight of children. 
 
Do not use Kentera after the expiry date which is stated on the multidose container with metering 
pump and the carton after EXP.  The expiry date refers to the last date of the month. 
 
Do not refrigerate or freeze.  Store pump in the upright position. 
 
Kentera contains alcohol and is considered flammable. The product should not come in contact with 
an open flame. 
 
Apply immediately after dose delivered from the multidose container with metering pump.  Discard 
empty multidose containers in accordance with local requirements. 
 
 
6. FURTHER INFORMATION 
 
What Kentera contains 
 
- The active substance is oxybutynin. Each metered dose of 1 gram of gel contains 90.7 mg of 

oxybutynin resulting in a nominal delivery of approximately 4 mg/day.   

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 66 

 
- The other ingredients are: ethanol (96%), glycerol, hydroxypropylcellulose, sodium hydroxide 

(for pH adjustment), and purified water. 
 
What Kentera looks like and contents of the pump 
 
Kentera is a rapid drying, clear, smooth, odorless, and colorless hydroalcoholic gel that is packaged in 
a multidose container with metering pump.  Each multidose container contains at least 30 grams of 
Kentera and dispenses 30 metered 1 gram doses.  Each carton contains 1 multidose container with 
metering pump. 
 
The multidose container is comprised of an outer bottle with a pouch liner, a metering pump and a cap.  
 
Marketing Authorisation Holder 
 
Teva B.V. 
Swensweg 5 
2031 GA Haarlem 
The Netherlands 
 
Manufacturer 
 
Nicobrand Limited  
189 Castleroe Road 
Coleraine  
Northern Ireland 
BT51 3RP 
 
Teva Pharmaceuticals Europe B.V. 
Swensweg 5 
2031 GA Haarlem  
The Netherlands 
 
This leaflet was last approved in  
 
Detailed information on this medicine is available on the European Medicines Agency 
web site: http://www.ema.europa.eu 
 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
	B CONDITIONS OF THE MARKETING AUTHORISATION
	A. LABELLING
	B. PACKAGE LEAFLET