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.
FOR Oxybutynin Hydrochloride Tablets contain an active ingredient called Oxybutynin hydrochloride. This belongs to two groups of medicines called "anticholinergics and "antispasmodics". This medicine relaxes and prevents spasms (contractions) of the muscle of the bladder, and helps to control the release of urine. Oxybutynin Hydrochloride Tablets are used to treat the following in adults:
little water before you take one of these tablets.
Difficulty passing water (urine) Excitation Agitation Anxiety Becoming dependent on Oxybutynin Hydrochloride Tablets
E OXYBUTYNIN HYDROCHLORIDE TABLETS Do not take Oxybutynin Hydrochloride Tablets if you:
OXYBUTYNIN HYDROCHLORIDE TABLETS Always take this medicine exactly as your doctor or
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NON PRINTING COLOUR Oxybutynin Hydrochloride 2.5 mg / 5 mg Strides Pharma UK Ltd.
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Black PC-ODF/2026/103 – Record Number: 487438 Front & Back Page Printing. To be supplied in the folded size of 180 x 160 mm. 60 GSM Paper PRINTING CLARITY TO BE CLEAR AND SHARP.
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Like all medicines, this medicine can cause side effects, although not everybody gets them. Allergic reactions: If you experience an allergic reaction which may include symptoms such as swelling of the face, neck, throat or body, a rash which may be itchy, swallowing or difficulty breathing; stop taking the tablets and contact your doctor immediately. Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days: Very common (affects more than 1 in 10 people)
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pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is Adults The usual initial dose is 2.5mg three times a day. This dose may be increased to a maximum of 5mg four times a day. Elderly Initially 2.5mg twice a day increased to 5mg twice a day according to response. Use in children (over 5 years) and adolescents Urinary incontinence: The usual dose is 2.5mg twice a day. This may be increased to 5mg two or three times a day. Bed wetting: The usual dose is 2.5mg twice a day, increased to 5mg two or three times a day, with the last dose given before bedtime. Children under 5 years Not recommended. Swallow the tablet whole with a glass of water. The dose recommendations given above are a guideline only. Your doctor may prescribe a different dose. If you take more Oxybutynin Hydrochloride Tablets than you should: An overdose of this medicine may be harmful. Symptoms of overdose include restlessness, excitement, abnormal behaviour, flushing, fall in blood pressure, problems with your circulation, breathing problems, paralysis and coma. If you or someone else, have taken too much of your medicine tell your doctor or pharmacist, or go to the nearest hospital casualty department immediately. Take the medicine pack with you, to inform the doctor what you have taken. If you forget to take Oxybutynin Hydrochloride Tablets: If you forget to take a dose at the right time, take it as soon as you remember, then go on as before. However you must take care not to take two doses at the same time. Do not take a double dose to make up for a forgotten dose. If you stop taking Oxybutynin Hydrochloride Tablets Do not stop or change the treatment before talking to your doctor as desired effect of the medicine may not be achieved. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
OXYBUTYNIN HYDROCHLORIDE TABLETS Keep this medicine out of the sight and reach of children. Do not store above 25°C. Do not use this medicine after the expiry date which is stated on the label. The expiry refers to the last day of that month. Do not use this medicine if you notice visible signs of deterioration. 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 protect the environment.
What Oxybutynin Hydrochloride Tablets contain The active substance(s) is Oxybutynin Hydrochloride/ Oxybutynin Chloride BP/Ph.Eur. The other ingredients are: Lactose monohydrate, Microcrystalline cellulose, Calcium stearate, Indigo carmine (aluminium lake) E132 What Oxybutynin Hydrochloride Tablets look like and contents of the pack Description: Oxybutynin Hydrochloride Tablets 2.5 mg: Blue, biconvex, uncoated capsule-shaped tablets, marked "OB" scoreline "2.5" on one side and plain on the other side. Oxybutynin Hydrochloride Tablets 5 mg: Blue, round, biconvex, uncoated tablets, marked "OB" breakline "5" on one side and plain on the other side. Contents of pack: Blister pack containing 56 or 84 tablets. 7 tablets in a blister, 8 or 12 blisters in a carton. Marketing Authorisation Holder and Manufacturer Strides Pharma UK Ltd. Unit 4, The Metro Centre, Dwight Road, Watford , WD18 9SS United Kingdom, This leaflet was last revised in March 2026.
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NON PRINTING COLOUR Oxybutynin Hydrochloride 2.5 mg / 5 mg Strides Pharma UK Ltd.
Pack Insert —-
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Black PC-ODF/2026/103 – Record Number: 487438 Front & Back Page Printing. To be supplied in the folded size of 180 x 160 mm. 60 GSM Paper PRINTING CLARITY TO BE CLEAR AND SHARP.
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Oxybutynin Hydrochloride Tablets 2.5 mg comes as tablet containing 2.5mg. 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 Tablets 2.5 mg is oxybutynin hydrochloride.
Medicines with the same active substance, strength and form include: Ditropan 2.5mg Tablets, Oxybutynin Hydrochloride 2.5mg Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Oxybutynin Hydrochloride Tablets 2.5 mg, 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.
Adults
Urinary incontinence, urgency and frequency in unstable bladder conditions due to idiopathic detrusor instability (motor urge incontinence) or neurogenic bladder disorders (detrusor hyperreflexia) in conditions such as multiple sclerosis and spina bifida.
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 over activity)
• Nocturnal enuresis associated with detrusor over activity, in conjunction with non-drug therapy, when other treatment has failed
The dosage should be adapted individually. Unless otherwise specified, the following recommendations apply:
Adults
The usual initial dose is 2.5mg three times a day. This dose may be increased to a maximum dose of 5mg four times a day to obtain a clinical response provided that the side effects are well-tolerated.
Elderly (including frail elderly)
A lower dose is recommended because the elimination half-life is increased in the elderly. A dose of 2.5mg twice a day is likely to be adequate, particularly if the patient is frail. This dose may be increased if necessary to 5mg twice a day provided that the side effects are well tolerated.
Children (under 5 years of age)
Not recommended
Children (over 5 years of age)
Neurogenic bladder instability: The usual dose is 2.5mg twice a day. 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
Nocturnal enuresis: The usual dose is 2.5mg twice a day. This dose may be increased, if necessary, to 5mg two or three times daily provided that the side effects are well-tolerated. The last dose should be given before bedtime.
Method of administration
Oral use.
The tablets are swallowed with plenty of fluid (approx. 1 glass of water), also recommended because the tablets have an unpleasant taste.
The duration of treatment is guided by the occurrence of symptoms.
Oxybutynin hydrochloride tablets are contraindicated in patients with:
- hypersensitivity to oxybutynin hydrochloride or any of the excipients listed in section 6.1.
- myasthenia gravis
- narrow-angle glaucoma or shallow anterior chamber.
- pollakiuria or nycturia due to cardiac or renal insufficiency.
- gastrointestinal obstruction including pyloric stenosis, paralytic ileus and intestinal atony.
- ileostomy, colostomy, toxic megacolon, severe ulcerative colitis.
- bladder flow obstruction where urinary retention may be precipitated.
- porphyria
- frequent urination at night caused by heart or kidney disease
- hiatus hernia with reflux oesophagitis
Oxybutynin hydrochloride tablets should be used with caution in the frail elderly and children who may be more sensitive to the effects of the product and in patients with autonomic neuropathy (such as those with Parkinson's disease), severe gastrointestinal motility disorders, hepatic or renal impairment and hiatus hernia or other severe gastro-intestinal motility disorders (also see section 4.3).
Anticholinergics should be used with caution in elderly patients due to the risk of cognitive impairment.
Gastrointestinal disorders: 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 tachycardia (and thus be cautious in case of hyperthyroidism, congestive heart failure, cardiac arrhythmia, coronary heart disease, hypertension), cognitive disorders and symptoms of prostatic hypertrophy.
Anticholinergic central nervous system (CNS) effects (e.g. hallucinations, agitation, confusion, somnolence) have been reported; monitoring recommended especially in first few months after initiating therapy or 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 a physician immediately if they are aware of a sudden loss of visual acuity or ocular pain.
In the event of a urinary tract infection during treatment with oxybutynin, appropriate antibacterial treatment must be initiated.
Oxybutynin may reduce salivary secretions which could result in dental caries, parodontosis or oral candidiasis. Regular dental check-ups are therefore advisable during long-term treatment.
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.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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 over activity).
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.
Enhanced effect with other anticholinergics
Care should be taken if other anticholinergic agents are administered together with oxybutynin, as potentiation of anticholinergic effects may occur Concomitant treatment can also lead to confusion in the elderly.
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 anti-Parkinsonian 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 P 450 isoenzyme CYP 3A4. Concomitant administration with a CYP3A4 inhibitor can inhibit oxybutynin metabolism and increase oxybutynin exposure (e.g. ketoconazole, itraconazole, erythromycin). Oxybutynin may antagonise prokinetic therapies (e.g. metoclopramide and domperidone).
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).
Reduced effect due to oxybutynin
By reducing gastric motility, Oxybutynin may affect the absorption of other drugs. Oxybutynin may also counteract the gastrointestinal effect if metoclopramide and domperidone.
Mutual Effect Mitigation
Oxybutynin is metabolised by cytochrome P 450 isoenzyme CYP 3A4. Concomitant administration with a CYP 3A4 inhibitor can inhibit oxybutynin metabolism and increase oxybutynin exposure (e.g. ketoconazole, itraconazole, erythromycin).
Other interactions
The ability to dissolve sublingual tablets under the tongue may be worsened due to dry mouth. Patients who take sublingual nitrates must therefore be advised to moisten their mouth with their tongue or with a little water before taking a sublingual tablet.
An interaction has been demonstrated between oxybutynin and itraconazole, which leads to a doubling of plasma oxybutynin levels but only a 10% increase in levels of the active metabolite. This appears to be of minor clinical significance.
Pregnancy:
There are no adequate data from the use of oxybutynin in pregnant women. Studies in animals have shown minor reproductive toxicity (see section 5.3). Animal studies are insufficient with respect to effects on pregnancy, embryonic / foetal development, parturition or postnatal development (see section 5.3). The potential risk for humans is unknown. Oxybutynin should not be used in pregnancy unless clearly necessary.
Breast-feeding:
Oxybutynin in small amount is excreted in breast milk during lactation. Oxybutynin should not be used during breast-feeding.
Fertility:
There are no data regarding effects on human fertility. Studies in animals have shown impaired fertility in females.
Oxybutynin hydrochloride tablets can cause drowsiness or blurred vision and patients should be cautioned regarding activities requiring mental alertness such as driving, operating machinery or performing hazardous work.
In clinical trials involving more than 3000 patients exposed to oxybutynin hydrochloride, side effects were caused mainly by anticholinergic effects of oxybutynin. Dry mouth was the most commonly reported side effect.
Frequency of adverse reactions is based on safety data from clinical studies with oxybutynin hydrochloride 2.5 mg and 5 mg, and the experience gained after the drug has been marketed.
Classification of expected frequencies:
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); not known (cannot be estimated from the available data).
The following adverse events (marked with an asterisk *), which has not been observed in clinical trials but reported after the drug has been marketed, has been ranked in the frequency of "rare/unknown".
Very Common
Common
Uncommon
Rare
Not Known
Infections and infestations
urinary tract infection
Immune System Disorders
hypersensitivity
Psychiatric disorders
confusional state
Restlessness*, disorientation, concentration difficulties, excitation.
Agitation anxiety, hallucinations, nightmares*, paranoia, agitation, cognitive disorders in elderly, symptoms of depression, dependence to oxybutynin (in patients with history of drug or substance abuse)
Nervous System Disorders
somnolence, fatigue, headache, dizziness
drowsiness
Cognitive disorders*, convulsions*, disorientation
Eye disorders
decreased tear production /Dry eyes
light hypersensitivity
Narrow angle closure glaucoma*, mydriasis, ocular hypertension, blurred vision
Cardiac disorders
palpitation
cardiac arrhythmias, tachycardia
Vascular disorders
flushing which may be more marked in children
Gastrointestinal Disorders
dry mouth, nausea, constipation
diarrhoea, vomiting, dyspepsia
anorexia, dysphagia, abdominal discomfort/pain, decreased appetite
gastroesophageal reflux disease, pseudo-obstruction in patients at risk (elderly or patients with constipation and treated with other drugs that decrease intestinal motility)
Skin and subcutaneous tissue disorders
dry skin/ decreased sweating
phototoxicity
angioedema, rash, urticaria, hypohidrosis,
Renal and urinary disorders
Urinary retention
difficulty in micturition
Reproductive system and breast disorders
erectile dysfunction*
Injury, poisoning and procedural complications
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
The symptoms of over dosage with oxybutynin progress from an intensification of the usual side effects of CNS disturbances (from restlessness confusion, hallucinations including psychotic behaviour, ataxia, bewilderment, nervousness), circulatory changes (hot feeling, flushing, fall in blood pressure, light-headedness, circulatory failure, arrhythmia, tachycardia, facial redness.), respiratory failure, paralysis and coma.
Measures to be taken are:
1. Immediate gastric lavage and administration of actual charcoal
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.
Children: 30 micrograms/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 effect to the paralysis of the respiratory muscles, mechanical ventilation will be required.
Ask anything about Oxybutynin Hydrochloride Tablets 2.5 mg. 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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