Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Oxybutynin hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
e Oxybutynin hydrochloride tablets Do not take Oxybutynin hydrochloride tablets
Children 5 years of age or older Oxybutynin hydrochloride tablets should be taken with caution as they may be more sensitive to the effects of the product and at a greater risk of occurrence of adverse reactions. Other medicines and Oxybutynin hydrochloride tablets Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. This is because Oxybutynin can affect the way some other medicines work. Also, some other medicines can affect the way Oxybutynin works. In particular, tell your doctor if you are taking any one of the following:
Oxybutynin hydrochloride tablets Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Taking this medicine
Dosage
5 – 9 years
2.5 mg three times daily
9 – 12 years
5 mg twice daily
older than 12 years
5 mg three times daily
If you feel that the effects of Oxybutynin hydrochloride tablets are too strong or too weak, ask your doctor or pharmacist for advice. Oxybutynin hydrochloride tablets should not be used in children under the age of 5. Taking Oxybutynin hydrochloride tablets Your doctor will tell you for how long Oxybutynin hydrochloride tablets must be used. It is recommended that the effect should be re-assessed after 4 to 6 weeks, because normal bladder function may have returned.
Taking Oxybutynin hydrochloride tablets with food or drink The tablets should be taken on an empty stomach with plenty of water. If irritation of the stomach occurs, the tablets may be taken during a meal or with some milk. If you take more Oxybutynin hydrochloride tablets than you should If you take more Oxybutynin hydrochloride tablets than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. Taking too much Oxybutynin hydrochloride tablets can be very dangerous. You may become very restless or excited, flushed or get dizzy or light-headed. Your heartbeat may become very fast, uneven, or forceful or your blood pressure drops. You may get breathing problems or numbness or go into a coma. If you forget to take Oxybutynin hydrochloride tablets If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. If you stop taking Oxybutynin hydrochloride tablets Keep taking Oxybutynin until your doctor tells you to stop. Do not stop taking Oxybutynin just because you feel better. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everyone gets them. Stop taking Oxybutynin hydrochloride tablets and see a doctor or go to a hospital immediately if: Frequency not known (frequency cannot be estimated from the available data)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Frequency not known (frequency cannot be estimated from the available data)
Additional side effects in children Children are at higher risk of the effects.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting
you can help provide more information on the safety of this medicine.
Oxybutynin hydrochloride tablets Do not store above 25°C. Store in the original pack. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. Always hand over any left-over medicine to the pharmacist for safe disposal. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
What Oxybutynin hydrochloride 2.5 mg / 3 mg / 5 mg tablets contain
M0200LAMUKNA-P1-005
Oxybutynin hydrochloride 5 mg tablets comes as tablet containing 5mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Oxybutynin hydrochloride 5 mg tablets is oxybutynin hydrochloride.
Medicines with the same active substance, strength and form include: Ditropan 5mg Tablets, Lyrinel XL 5 mg prolonged release tablet, Oxybutynin Hydrochloride 5mg Tablets. In total there are 5 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Oxybutynin hydrochloride 5 mg tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Oxybutynin hydrochloride is indicated for urinary incontinence, urgency and frequency in 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).
Posology
Adults: The dosage should be determined individually, with an initial dose of 2.5 mg three times daily. Thereafter, the lowest effective dose should be selected. The daily dose may vary between 10 and 15 mg per day (maximum dose is 20 mg per day) divided into 2-3 (max. 4) doses.
Elderly: The elimination half-life is increased in the elderly. Therefore, a dose of 2.5mg twice a day, particularly if the patient is frail, is likely to be adequate. This dose may be titrated upwards to 5mg two times a day to obtain a clinical response provided the side effects are well tolerated.
Children (under 5 years of age): The safety and efficacy of oxybutynin hydrochloride in children below 5 years of age has not been established. No data are available.
Children (over 5 years of age): The dosage should be determined individually, with an initial dose of 2.5 mg twice daily. Thereafter, the lowest effective dose should be selected. The maximum dose, which is related to body weight (0,3 - 0,4 mg / kg / day), is expressed in the following table:
Age
Dosage
5-9 years
2.5 mg three times daily
9-12 years
5 mg 2 times daily
Over 12 years
5 mg three times daily
Neurogenic bladder instability: the usual dose is 2.5mg twice a day. This dose may be titrated upwards to 5mg two or three times a day to obtain a clinical response provided the side effects are well tolerated. Nocturnal enuresis: the usual dose is 2.5 mg twice a day. This dose may be titrated upwards to 5mg 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.
The tablets can be taken on an empty stomach.
The tablet should be swallowed whole, with appropriate amount of water.
Method of administration
The tablets have to be swallowed with plenty of fluid and may be taken on an empty stomach. If gastric irritation occurs the tablets may also be taken during meals or with some milk.
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Narrow-angle glaucoma or shallow anterior chamber.
Myasthenia gravis.
Gastrointestinal obstructive disorders including paralytic ileus, intestinal atony.
Patients with severe ulcerative colitis.
Patients with toxic megacolon.
Patients with bladder outflow obstruction where urinary retention may be precipitated.
Oxybutynin should be used with caution in patients with Parkinson's disease who are at greater risk of occurrence of adverse reactions to the product and in patients with autonomic neuropathy (such as those with Parkinson's disease), severe gastro- intestinal motility disorders, hepatic or renal impairment.
Anticholinergic medicinal products may decrease gastrointestinal motility and should be used with caution in patients with gastrointestinal obstructive disorders, intestinal atony and ulcerative colitis.
Oxybutynin may aggravate cognitive disorders, symptoms of prostatic hypertrophy and tachycardia (thus be cautious in case of hyperthyroidism, congestive heart failure, cardiac arrhythmia, coronary heart disease, hypertension).
Anticholinergic CNS effects (such as hallucinations, agitation, confusion, somnolence) have been reported. Monitoring recommended, particularly in first few months after initiating therapy or increasing the dose. If anticholinergic CNS effects develop, termination of treatment or dose reduction may be considered.
Since oxybutynin can cause narrow-angle glaucoma, patients should be advised to contact a physician 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, parodontosis or 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 heat prostration 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 been established whether oxybutynin can be safely used in this age group.
There is limited evidence supporting the use of oxybutynin in children with monosymptomatic 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 psychiatric adverse reactions.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Care should be taken if other anticholinergic agents are administered together with Oxybutynin hydrochloride, as potentiation of anticholinergic effects could occur.
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, digitalis, tricyclic antidepressants, atropine and related compounds like atropinic antispasmodics and dipyridamole.
By reducing gastric motility, oxybutynin may affect the absorption of other drugs. Oxybutynin is metabolised by cytochrome P450 isoenzyme CYP 3A4. Concomitant administration with a CYP 3A4 inhibitor can inhibit oxybutynin metabolism and increase oxybutynin exposure.
Oxybutynin, as an anticholinergic agent, may antagonize the effect of prokinetic therapies.
Concomitant use with cholinesterase inhibitors may result in reduced cholinesterase inhibitor efficacy.
Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as oxybutynin (see section 4.7).
Pregnancy: There are no adequate data from the use of oxybutynin in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). The potential risk for humans is unknown. Oxybutynin hydrochloride should not be used during pregnancy unless clearly necessary.
Breast-feeding: When oxybutynin is used during lactation, a small amount is excreted in mother's milk. Breast feeding while using Oxybutynin is therefore not recommended.
Oxybutynin may cause drowsiness or blurred vision. Patients should be cautioned regarding activities requiring mental alertness such as driving, operating machinery or performing hazardous work while taking this drug.
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
Psychiatric Disorders
Common
confusional state
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)
Nervous System Disorders
Very common
dizziness, headache, somnolence
Not known
cognitive disorders, convulsions, drowsiness, disorientation
Eye Disorders
Very common
vision blurred
Common
dry eyes
Not known
angle closure glaucoma, increased intraocular pressure, mydriasis
Cardiac Disorders
Not known
arrhythmia, tachycardia
Common
palpitation
Vascular Disorders
Common
flushing (which may be more marked in children)
Respiratory, thoracic, and mediastinal disorders
Not known
epistaxis
Gastrointestinal Disorders
Very common
constipation, dry mouth, nausea
Common
diarrhoea, vomiting
Uncommon
abdominal discomfort, anorexia, decreased appetite, dysphagia
Not known
gastroesophageal reflux, pseudoobstruction in patients at risk (elderly or patients with constipation and treated with other drugs that decrease intestinal motility)
Skin and Subcutaneous Tissue Disorders
Very common
dry skin
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
Renal and Urinary Disorders
Common
urinary retention
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. 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 using the Yellow Card Scheme, at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Symptoms of intoxication:
The symptoms of overdosage with oxybutynin progress from an intensification of the usual side effects of CNS disturbances (from restlessness and excitement to psychotic behaviour), circulatory changes (flushing, fall in blood pressure, circulatory failure, etc.), respiratory failure, paralysis and coma.
Management:
Measures to be taken are:
1) Immediate gastric lavage
2) Physostigmine by slow intravenous injection
Adults: 0.5 to 2.0 mg of physostigmine by slow intravenous administration. Repeat after 5 minutes, if necessary up to a maximum total dose of 5mg.
Paediatric population: 30 µg/kg of physostigmine by slow intravenous administration. Repeat after 5 minutes, if necessary up to a maximum total dose of 2mg.
Fever should be treated symptomatically with tepid sponging or ice packs.
In pronounced restlessness or excitation, diazepam 10mg may be given by intravenous injection, tachycardia may be treated by intravenous injection of propranolol and urinary retention can be managed by bladder catheterisation.
In the event of progression of the curare- like effects to paralysis of the respiratory muscles, mechanical ventilation will be required.
Ask anything about Oxybutynin hydrochloride 5 mg tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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