Oxybutynin is an active pharmaceutical ingredient in the Drugs For Urinary Frequency and Incontinence group (G04BD). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised February 20, 2026[1]
Urinary incontinence, urgency and frequency in the unstable bladder, whether due to neurogenic bladder disorders (detrusor hyperreflexia) in conditions such as multiple sclerosis and spina bifida, or to idiopathic detrusor instability (motor urge incontinence).
Paediatric population Oxybutynin hydrochloride is indicated in children over 5 years of age for: - Urinary incontinence, urgency and frequency in unstable bladder conditions due to idiopathic overactive bladder or neurogenic bladder disorders (detrusor overactivity).
- Nocturnal enuresis associated with detrusor overactivity, in conjunction with non- drug therapy, when other treatment has failed.
How to take
USUnited States· FDA
7 products
Uses
USOfficial regulatory label· revised May 31, 2023[2]
1 INDICATIONS AND USAGE Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. , spina bifida). Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
, spina bifida). (1)
How to take
CACanada· Health Canada
2 products
Uses
CAOfficial regulatory label· revised March 22, 2025[3]
AND CLINICAL USE ..................................................................................................... 3 CONTRAINDICATIONS ......................................................................................................................
4 WARNINGS AND PRECAUTIONS ....................................................................................................... 4 ADVERSE REACTIONS .......................................................................................................................
6 DRUG INTERACTIONS ...................................................................................................................... 9 DOSAGE AND ADMINISTRATION ....................................................................................................
9 OVERDOSAGE ................................................................................................................................. 10 ACTION AND CLINICAL PHARMACOLOGY ..................................................................................
EUEuropean Union· EMA
1 product
Uses
EUOfficial regulatory label· revised April 8, 2025[4]
Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with unstable bladder.
How to take
EU
Drug interactions
Known interactions involving Oxybutynin. Select one for details. This list is informational and not a complete interaction checker.
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Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PL495780002 · revised February 20, 2026
[2]FDA DailyMed · 02ff3be7-fc5c-4b… · revised May 31, 2023 [PDF]
[3]Health Canada (DPD) · 02158590 · revised March 22, 2025
[4]European Medicines Agency · EMEA/H/C/000532 · revised April 8, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
GBOfficial regulatory label· revised February 20, 2026[1]
Dosage and administration:
Adults: The usual dose is 5 mg (10 ml) two or three times a day. This may be increased to a maximum of 5 mg (10 ml) four times a day to obtain a clinical response provided that the side effects are tolerated.
Elderly (including frail elderly):
The elimination half-life is increased in the elderly. 5 mg (5 ml) twice a day, particularly if the patient is frail, is likely to be adequate. This dose may be titrated upwards to 5 mg (10 ml) two times a day to obtain a clinical response provided the side effects are well tolerated.
5 mg (5 ml) twice a day. This dose may be titrated upwards to 5 mg (10 ml) two or three times a day to obtain a clinical response provided the side effects are well tolerated. 5 mg (5 ml) twice a day. This dose may be titrated upwards to 5mg (10 ml) two or three times a day to obtain a clinical response provided the side effects are tolerated.
The last dose should be given before bedtime.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised February 20, 2026[1]
Like all medicines, oxybutynin can cause undesirable effects, although not everybody gets them. The frequency of possible undesirable effects listed below are currently 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), not known (cannot be estimated from the available data).
ADVERSE REACTIONS REPORTED System Organ Class Frequency Adverse Reaction (MedDRA Terms) Infections and Infestations Not known Urinary tract infection Immune System Disorders Not known Hypersensitivity Common Confusional statePsychiatric Disorders Not known Agitation, anxiety, cognitive disorders in elderly, hallucinations, nightmares, paranoia, symptoms of depression, dependence to oxybutynin (in patients with history of drug or substance abuse) Very common Dizziness, headache, somnolenceNervous System Disorders Not known Cognitive disorders, convulsions, drowsiness, disorientation Very common Vision blurred Common Dry eyes Eye Disorders Not known Angle closure glaucoma, increased intraocular pressure, mydriasis Not known Arrhythmia, tachycardiaCardiac Disorders Common Palpitation Vascular Disorders Common Flushing (which may be more marked in children) Respiratory, Thoracic, and Mediastinal Disorders Not known Epistaxis ADVERSE REACTIONS REPORTED System Organ Class Frequency Adverse Reaction (MedDRA Terms) Very common Constipation, dry mouth, nausea Common Diarrhoea, vomiting Uncommon Abdominal discomfort, anorexia, decreased appetite, dysphagia Gastrointestinal Disorders Not known Gastroesophageal reflux, pseudo-obstruction in patients at risk (elderly or patients with constipation and treated with other drugs that decrease intestinal motility) Very common Dry skin Skin and Subcutaneous Tissue Disorders Not known Angioedema, hypohidrosis, rash, urticaria, photosensitivity Musculoskeletal and Connective Tissue Disorders Not known Muscle disorders manifested as muscle weakness, myalgia and/or muscle spasms Common Urinary retentionRenal and Urinary Disorders Not known Difficulty in micturition Injury, Poisoning and Procedural Complications Not known Heat stroke Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised February 20, 2026[1]
3). • Gastrointestinal disorders: Anticholinergic medicinal products may decrease gastrointestinalmotility and should be used with caution in patients with gastrointestinal obstructive disorders, intestinal atony and ulcerative colitis.
• Oxybutynin may aggravate tachycardia (and thus be cautious in case of hyperthyroidism, congestive heart failure, cardiac arrhythmia, coronary heart disease, hypertension), cognitivedisorders and symptoms of prostatic hypertrophy.
g. hallucinations, agitation, confusion, somnolence) have been reported; monitoring recommended especially in first few months after initiating therapyor increasing the dose; consider discontinuing therapy or reducing the dose if anticholinergic CNS effects develop.
• Since oxybutynin can cause narrow-angle glaucoma, patients should be advised to contact aphysician immediately if they are aware of a sudden loss of visual acuity or ocular pain. • Oxybutynin may reduce salivary secretions which could result in dental caries, parodontosisor oral candidiasis.
• 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.
• When oxybutynin is used in high environmental temperatures, this can cause heatprostration due to decreased sweating. Elderly Anticholinergic medicinal products should be used with caution in elderly patients due to the risk of cognitive impairment.
They also have a higher risk of occurrence of adverse reactions to the product. Paediatric population The use of oxybutynin in children under 5 years of age is not recommended; it has not beenestablished whether oxybutynin can be safely used in this age group.
There is limited evidence supporting the use of Oxybutynin in children withmonosymptomatic nocturnal enuresis (not related to detrusor overactivity). In children over 5 years of age, Oxybutynin hydrochloride should be used with caution as they may be more sensitive to the effects of the product, particularly the CNS and psychiatricadverse reactions.
Excipient warnings Sorbitol: 125 mg sorbitol in each ml, which is equivalent to 625 mg per dose of 5 ml. Sorbitol is a source of fructose. The additive effect of concomitantly administered productscontaining sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be takeninto account.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised February 20, 2026[1]
Hypersensitivity to oxybutynin or any component. Myasthenia gravis. Narrow-angle glaucoma or shallow anterior chamber. Gastrointestinal obstructive disorders including paralytic ileus, intestinal atony. Patients with toxic megacolon. Patients with severe ulcerative colitis.
Patients with bladder outflow obstruction where urinary retention may be precipitated.
This is not medical advice. Consult a qualified healthcare professional.
USOfficial regulatory label· revised May 31, 2023[2]
2 DOSAGE AND ADMINISTRATION Oxybutynin chloride extended-release tablets must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed. Oxybutynin chloride extended-release tablets may be administered with or without food.
Oxybutynin chloride extended-release tablets must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed. Oxybutynin chloride extended-release tablets may be administered with or without food. (2) Adults: Start with 5 mg or 10 mg, once daily at approximately the same time every day.
Dose should not exceed 30 mg per day. 1 ) Pediatric patients (6 years of age or older): Start with 5 mg, once daily at approximately the same time every day. Dose should not exceed 20 mg per day. 1 Adults The recommended starting dose of Oxybutynin chloride extended-release tablets is 5 or 10 mg once daily at approximately the same time each day.
Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 30 mg/day). In general, dosage adjustment may proceed at approximately weekly intervals. 2 Pediatric Patients Aged 6 Years of Age and Older The recommended starting dose of Oxybutynin chloride extended-release tablets is 5 mg once daily at approximately the same time each day.
Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 20 mg/day).
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised May 31, 2023[2]
6 ADVERSE REACTIONS The most common (incidence ≥5%) adverse reactions were dry mouth, constipation, diarrhea, headache, somnolence, and dizziness. (6) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE, Inc. gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety and efficacy of Oxybutynin chloride extended-release tablets (5 to 30 mg/day) was evaluated in 774 adult subjects who participated in five double-blind, controlled clinical trials. In four of the five studies, Oxybutynin chloride IR (5 to 20 mg/day in 199 subjects) was an active comparator.
Adverse reactions reported by ≥ 1% of subjects are shown in Table 1. 0 Investigations Residual urine volume The bundled term residual urine volume consists of the preferred terms residual urine volume and residual urine volume increased.
4% with Oxybutynin chloride extended-release tablets compared to 0% with Oxybutynin chloride IR. 7% ). The following adverse reactions were reported by <1% of Oxybutynin chloride extended-release tablets-treated patients and at a higher incidence than placebo in clinical trials: Metabolism and Nutrition Disorders: anorexia, fluid retention; Vascular disorders: hot flush; Respiratory, thoracic and mediastinal disorders: dysphonia; Gastrointestinal Disorders: dysphagia, frequent bowel movements; General disorders and administration site conditions: chest discomfort, thirst.
2 Postmarketing Experience The following additional adverse reactions have been reported from worldwide postmarketing experience with Oxybutynin chloride extended-release tablets. Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Infections and Infestations:
Urinary tract infection; Psychiatric Disorders: psychotic disorder, agitation, confusional state, hallucinations, memory impairment; Nervous System Disorders: convulsions; Eye Disorders: glaucoma; Respiratory, Thoracic and Mediastinal Disorders: nasal congestion; Cardiac Disorders: arrhythmia, tachycardia, palpitations; QT interval prolongation; Vascular Disorders: flushing, hypertension; Skin and Subcutaneous Tissue Disorders: rash; Renal and Urinary Disorders: impotence;General Disorders and Administration Site Conditions: hypersensitivity reactions, including angioedema with airway obstruction, urticaria, and face edema; anaphylactic reactions requiring hospitalization for emergency treatment; Injury, poisoning and procedural complications: fall.
Additional adverse events reported with some other oxybutynin chloride formulations include: cycloplegia, mydriasis, and suppression of lactation. To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. gov/medwatch .
USOfficial regulatory label· Warnings and precautions· revised May 31, 2023[2]
5 WARNINGS AND PRECAUTIONS Angioedema: Angioedema has been reported with oxybutynin. If symptoms of angioedema occur, discontinue Oxybutynin chloride extended-release tablets immediately and initiate appropriate therapy. 1 ) Central Nervous System (CNS) effects: CNS effects have been reported with oxybutynin.
If patient experiences anticholinergic CNS effects, consider dose adjustment or discontinuation of Oxybutynin chloride extended-release tablets. 3 ), and Decreased gastrointestinal motility in patients with autonomic neuropathy. 5 ) Gastrointestinal Adverse Reactions: Use with caution in patients with gastrointestinal obstructive disorders or decreased intestinal motility due to risk of gastric retention.
Use with caution in patients with gastroesophageal reflux or in patients concurrently taking drugs that can exacerbate esophagitis. 1 Angioedema Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose.
Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, oxybutynin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.
2 Central Nervous System Effects Oxybutynin is associated with anticholinergic central nervous system (CNS) effects [see Adverse Reactions (6) ]. A variety of CNS anticholinergic effects have been reported, including hallucinations, agitation, confusion and somnolence.
Patients should be monitored for signs of anticholinergic CNS effects, particularly in the first few months after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how Oxybutynin chloride extended-release tablets affect them.
If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered. Oxybutynin chloride extended-release tablets should be used with caution in patients with preexisting dementia treated with cholinesterase inhibitors due to the risk of aggravation of symptoms.
Oxybutynin chloride extended-release tablets should be used with caution in patients with Parkinson's disease due to the risk of aggravation of symptoms. 3 Worsening of Symptoms of Myasthenia Gravis Oxybutynin chloride extended-release tablets should be used with caution in patients with myasthenia gravis due to the risk of symptom aggravation.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised May 31, 2023[2]
4 CONTRAINDICATIONS Oxybutynin chloride extended-release tablets are contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma.
Oxybutynin chloride extended-release tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product. There have been reports of hypersensitivity reactions, including anaphylaxis and angiodema.
Urinary retention (4) Gastric Retention (4) Uncontrolled narrow angle glaucoma (4) Known hypersensitivity to Oxybutynin chloride extended-release tablets, oxybutynin or any component of Oxybutynin chloride extended-release tablets (4)
This is not medical advice. Consult a qualified healthcare professional.
11 STORAGE AND STABILITY ............................................................................................................... 12 DOSAGE FORMS, COMPOSITION AND PACKAGING .....................................................................
12 PART II: SCIENTIFIC INFORMATION................................................................................................... 14 PHARMACEUTICAL INFORMATION .................................................................................................
20 PART III: CONSUMER INFORMATION ................................................................................................. e. urgency, frequency, urinary leakage, urge incontinence, dysuria).
Geriatrics (> 65 years of age):
Clinical studies of oxybutynin chloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between healthy elderly and younger patients.
Page 4 of 23 Pediatrics (< 5 years of age):
The safety and effectiveness of oxybutynin chloride in pediatric patients under 5 years of age have not been established. CONTRAINDICATIONS OXYBUTYNIN/OXYBUTYNIN SYRUP (oxybutynin chloride) is contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma, and in patients who are at risk for these conditions.
OXYBUTYNIN/OXYBUTYNIN SYRUP is contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product. For a complete listing of the nonmedicinal ingredients, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the Product Monograph.
WARNINGS AND PRECAUTIONS General Anticholinergics, such as OXYBUTYNIN/OXYBUTYNIN SYRUP, can cause heat prostration (fever and heat stroke due to decreased sweating) when administered in the presence of high environmental temperature.
Because anticholinergic agents, such as OXYBUTYNIN/OXYBUTYNIN SYRUP may produce drowsiness or blurred vision, the patient should be cautioned regarding activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug.
Alcohol or other sedative drugs may enhance the drowsiness caused by anticholinergic agents such as OXYBUTYNIN/OXYBUTYNIN SYRUP. Pretreatment examinations should include cystometry and other appropriate diagnostic procedures. Cystometry should be repeated at appropriate intervals to evaluate response to therapy.
The appropriate antibiotic therapy should be instituted in the presence of infection.
Page 5 of 23 Carcinogenesis and Mutagenesis See Product Monograph Part II:
TOXICOLOGY, Carcinogenesis and Mutagenesis, for discussion on animal data. Cardiovascular The symptoms of coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia and hypertension may be aggravated following administration of OXYBUTYNIN/OXYBUTYNIN SYRUP.
Endocrine and Metabolism The symptoms of hyperthyroidism and prostatic hypertrophy may be aggravated following administration of OXYBUTYNIN/OXYBUTYNIN SYRUP. Gastrointestinal OXYBUTYNIN/OXYBUTYNIN SYRUP should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention (see CONTRAINDICATIONS).
Administration of OXYBUTYNIN/OXYBUTYNIN SYRUP to patients with severe ulcerative colitis may precipitate toxic megacolon. […]
9 mg transdermal patch applied twice weekly (every 3 to 4 days). Elderly Based on clinical trial experience no dose adjustment is considered necessary in this population. 4). Paediatric population The safety and efficacy of Kentera in the paediatric population has not been established.
Kentera is not recommended for use in the paediatric population. 8 but no recommendation on a posology can be made. Method of administration The patch should be applied to dry, intact skin on the abdomen, hip, or buttock immediately after removal from the protective sachet.
A new application site should be selected with each new patch to avoid reapplication to the same site within 7 days. The patch must not be divided or cut into pieces. Patches that are damaged should not be used.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised April 8, 2025[4]
1% of patients. 3%). Tabulated list of adverse reactions Adverse reactions from phase 3 and 4 clinical studies are listed below by system organ class and frequency grouping. Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Post- marketing adverse reactions not seen in clinical trials are also included. System Organ Class (MedDRA) Frequency Adverse reaction Infections and infestations Common Urinary tract infection Uncommon Upper respiratory tract infection, fungal infection Psychiatric disorders Uncommon Anxiety, confusion, nervousness, agitation, insomnia 5 # post-marketing adverse reactions from post-marketing reports only (not seen in clinical trials), with the frequency category estimated from clinical trial safety data, and reported in association with oxybutynin topical use (anticholinergic class effects).
Adverse reactions considered associated with anticholinergic therapy, in general or observed with oral administration of oxybutynin, but as of yet not with Kentera in clinical trials or post-marketing, are: anorexia, vomiting, reflux oesophagitis, decreased sweating, heat stroke, decreased lacrimation, mydriasis, tachycardia, arrhythmia, nightmares, restlessness, convulsion, intraocular hypertension and induction of glaucoma, paranoia, photosensitivity, erectile dysfunction.
Paediatric population During post-marketing use in this age group, cases of hallucinations (associated with anxiety manifestations) and sleep disorders correlated with oxybutynin have been reported. Children may be more sensitive to the effects of the product, particularly the CNS and psychiatric adverse reactions.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
EUOfficial regulatory label· Warnings and precautions· revised April 8, 2025[4]
Kentera should be used with caution in patients with hepatic or renal impairment. The use of Kentera in patients with hepatic impairment should be carefully monitored. Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Kentera.
If urinary tract infection is present, an appropriate antibacterial therapy should be started.
Urinary retention:
Anticholinergic products should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. Kentera should be used with caution in elderly patients, who may be more sensitive to the effects of centrally acting anticholinergics and exhibit differences in pharmacokinetics.
In total 496 patients were exposed to Kentera in the randomised, double-blind, placebo-controlled 12-week and the 14-week safety extension studies. Of these 188 patients (38%) were 65 years of age and older and exhibited no overall differences in safety or effectiveness compared to younger patients.
Thus based on current clinical evidence no need for dose adjustment in elderly patients is considered necessary. g. insomnia) and cognitive disorders have been associated with oxybutynin use, especially in elderly patients. 5). If a patient experiences such events, drug discontinuation should be considered.
8). Oral administration of oxybutynin may warrant the following cautionary statements, but these events were not observed during clinical trials with Kentera: Gastrointestinal disorders: Anticholinergic medicinal products may decrease gastrointestinal motility and should be used with caution in patients with gastrointestinal obstructive disorders because of the risk of gastric retention.
Also in conditions such as ulcerative colitis, and intestinal atony. Anticholinergic medicinal products should be used with caution in patients who have hiatus hernia/gastro-oesophageal reflux and/or who are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis.
Anticholinergic medicinal products should be used with caution in patients who have autonomic neuropathy, cognitive impairment or Parkinson's disease. Patients should be informed that heat prostration (fever and heat stroke due to decreased sweating) can occur when anticholinergics such as oxybutynin are used in a hot environment.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised April 8, 2025[4]
1. 3 Kentera is contraindicated in patients with urinary retention, severe gastro-intestinal condition, myasthenia gravis or narrow-angle glaucoma and in patients who are at risk for these conditions.
This is not medical advice. Consult a qualified healthcare professional.
The content of sorbitol in medicinal products for oral use may affect the bioavailability ofother medicinal products for oral use administered concomitantly. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinalproduct.
Sorbitol may cause gastrointestinal discomfort and mild laxative effect. Maltitol: 125 mg maltitol in each ml, which is equivalent to 625 mg per dose of 5 ml. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
35 mg per dose of 5 ml.
Sodium:
This medicine contains less than 1 mmol sodium (23mg) per 5 ml, that is to sayessentially “sodium-free”.
Methyl parahydroxybenzoate (E218):
May cause allergic reactions (possibly delayed), andexceptionally, bronchospasm.
Ethanol (E1510):
This medicinal product contains small amounts of ethanol (alcohol), less than100 mg per 5 ml.
4 Worsening of Symptoms of Decreased Gastrointestinal Motility in Patients with Autonomic Neuropathy Oxybutynin chloride extended-release tablets should be used with caution in patients with autonomic neuropathy due to the risk of aggravation of symptoms of decreased gastrointestinal motility.
5 Urinary Retention Oxybutynin chloride extended-release tablets should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention [see Contraindications (4) ].
6 Gastrointestinal Adverse Reactions Oxybutynin chloride extended-release tablets should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention [see Contraindications (4) ].
Oxybutynin chloride extended-release tablets, like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis and intestinal atony. Oxybutynin chloride extended-release tablets should be used with caution in patients who have gastroesophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis.
As with any other nondeformable material, caution should be used when administering Oxybutynin chloride extended-release tablets to patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic). There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other drugs in nondeformable controlled-release formulations.
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.