Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Ditropan 2.5mg Tablets
⚠ This medicine appears to have been discontinued
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.
What it is and what it is used for
for What Ditropan tablets are Ditropan tablets contain a medicine called oxybutynin hydrochloride. This belongs to two groups of medicines called 'anticholinergics' and 'antispasmodics'. How Ditropan tablets work It works by relaxing the muscles of the bladder and stops sudden muscle contractions (spasms). This helps control the release of water (urine). What Ditropan tablets are used for Ditropan tablets can be used in adults and children 5 years or older to treat: − loss of control in passing water (urinary incontinence), − increased need or urgency to pass water (urine), − night time bedwetting, when other treatments have not worked.
What you need to know before you take it
e Ditropan tablets Do not take Ditropan tablets − if you are allergic to oxybutynin hydrochloride or any of the other ingredients of this medicine (listed in section 6).
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− − − − − −
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. if you have a rare muscle illness called 'Myasthenia gravis'. if you have glaucoma (increased pressure in the eye, sometimes sudden and painful with blurred vision or loss of vision). if your gut (stomach or intestine) is blocked, perforated or not working properly. if you have a severe form of a condition known as 'ulcerative colitis'. if you have sudden widening of the colon, which causes abdominal pain, fever or shock known as 'toxic megacolon'. if you have a blockage that makes it difficult for you to pass water (urine).
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Ditropan tablets. Warnings and precautions Talk to your doctor or pharmacist before taking Ditropan tablets. Especially be careful if − you have kidney or liver problems. − you have an illness affecting the nerves called 'autonomic neuropathy' (e.g. Parkinson's disease). − you have an overactive thyroid gland (Hyperthyroidism). − you have heart disease or high blood pressure. − you have an irregular heartbeat (palpitations, arrythmias) and/or increased or rapid heartbeat. − you have an enlarged prostate gland (prostatic hypertrophy). − you have gastro-intestinal disorders or a disease called ulcerative colitis. − you have indigestion or heart burn caused by a 'hiatus hernia' (where part of your stomach pushes through the diaphragm), gastro-oesophageal reflux and/or you are using medicinal products that can cause or worsen oesophagitis. − you have a raised body temperature or fever. − you will be taking this medicine in a hot climate. Ditropan tablets may reduce the amount of saliva resulting in tooth decay or fungal infection of the mouth. Ditropan tablets can cause glaucoma (increased pressure in the eye). Please contact your doctor immediately if you suffer any blurred vision, loss of vision or have any pain in the eye. Ditropan tablets can cause hallucinations, agitation, confusion or somnolence so that your doctor might consider to monitor you. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Ditropan tablets. Elderly 2
People 65 years of age or older should take Ditropan tablets with caution, because of the risk of cognitive impairment and being at a greater risk of occurrence of adverse reactions. Children Children under 5 years of age The use of Ditropan tablets is not recommended in children under 5 years of age. Children 5 years of age or older Ditropan 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 Ditropan tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Ditropan tablets can affect the way some other medicines work. Also, some medicines can affect the way Ditropan tablets works. In particular, tell your doctor if you are taking any of the following: − Other anticholinergic or antimuscarinic medicines – such as some medicines for irritable bowel syndrome, asthma or incontinence, motion sickness or movement disorders associated with Parkinson's disease. − Medicines used to make you feel sleepy (sedatives). − Medicines used to treat nausea and vomiting (prochlorperazine or chlorpromazine). − Medicines used to treat certain mental illnesses such as clozapine, phenothiazines, haloperidol or benperidol (butyrophenones). − Medicines used to treat dementia e. g. donepezil, rivastigmine, galantamine or tacrine (cholinesterase inhibitors). − Medicines for depression such as Amitriptyline, Imipramine or Dosulepin ('tricyclic antidepressants'). − Amantadine used in Parkinson's disease or to treat and prevent some virus infections. − L-dopa or biperidin used to treat Parkinson's disease. − Digoxin or quinidine used to treat heart problems. − Atropine which is used to treat certain types of poisonings, a slow heart rate, some eye conditions or is given during surgery. − Medicines for stomach and bowel related problems – such as domperidone, metoclopromide, bethanechol. − Medicines to treat allergic symptoms (antihistamines). − CYP3A inhibitor e. g. ketoconazole, itraconazole or fluconazole used to treat fungal infections or erythromycin or other macrolide antibiotics used to treat bacterial infections. Ditropan tablets with alcohol If you drink alcohol while using Ditropan tablets, you may become very drowsy. Pregnancy and breast-feeding 3
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. While breast-feeding, small amounts may pass into mothers' milk. Breast-feeding while using this medicine is therefore not recommended. Driving and using machines You may feel drowsy or have blurred vision while you are taking this medicine. If this happens, do not drive or use any tools or machines. Ditropan tablets contain lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Ditropan tablets contain sodium This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially 'sodium-free'.
How to take it
Ditropan tablets Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Posology Your doctor will decide the dose appropriate for you. Adults The recommended dose is one 5 mg tablet two or three times each day. Your doctor may decide to increase to the maximum dose of 5 mg four times each day. Elderly The recommended dose is 2.5 mg twice each day. Your doctor may decide to increase this to 5 mg twice each day. Use in children and adolescents Children 5 years of age or older The recommended dose is one 2.5 mg tablet twice each day. Your doctor may decide to increase this to one 5 mg two or three times each day. If you are giving it to a child to prevent bedwetting, give the last dose just before bedtime. Method of administration For oral use. Swallow the tablets with a glass of water as they may taste unpleasant. 4
If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor. If you use more Ditropan tablets than you should If you take more Ditropan 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 Ditropan 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 Ditropan 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 Ditropan tablets Keep taking Ditropan tablets until your doctor tells you to stop. Do not stop taking Ditropan tablets just because you feel better. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Ditropan tablets and see a doctor or go to a hospital straight away if: Frequency not known (frequency cannot be estimated from the available data): − You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat, or tongue. − You may feel reduced sweating, leading to overheating in hot environments. 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): − constipation − nausea − dry mouth − dry skin − headache − somnolence (feeling drowsy or sleepy) − dizziness − blurring of vision 5
Common (affects 1 to 10 people in a 100 people): − dry eyes − diarrhoea − being sick (vomiting) − confusion − flushing especially in children − inability to completely empty the bladder (urinary retention) − a forceful heartbeat that may be rapid or irregular Uncommon (affects 1 to 10 people in a 1,000): − stomach pain − loss of appetite (anorexia) − difficulty in swallowing (dysphagia) Frequency not known: frequency cannot be estimated from the available data − increased pressure in the eyes sometimes sudden and painful with blurred vision or loss of vision (glaucoma) − indigestion or heartburn (acid reflux) − urinary tract infection − heat stroke − difficulty passing water (urine) − agitation − anxiety − becoming dependent on Ditropan tablets if there is a history of drug or substance abuse − feeling excessive suspicious and distrustful of others − mental Health disorders (especially in the in the elderly) − seeing or hearing things that are not there (hallucinations) − drowsiness − nightmares − fits (convulsions) − depression − increased heartbeat (tachycardia) − irregular heartbeat (arrhythmia) − dilation of pupil (mydriasis) − itchy, lumpy rash (urticaria) − absence of sweating (hypohidrosis) − skin that is more sensitive to the sun (photosensitivity) − disorientation − cognitive disorders − nosebleed − angioedema − muscle weakness, pain or cramps
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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, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
How to store it
Ditropan tablets 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 blister or carton after EXP. The expiry date refers to the last day of that month. Store below 30 ̊C. 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.
Contents of the pack and other information
What Ditropan tablets contain − The active substance is 2.5 mg or 5 mg oxybutynin hydrochloride in each tablet. − The other ingredients are lactose, cellulose, calcium stearate, and indigo carmine (E132). What Ditropan tablets look like and contents of the packs Ditropan 2.5 mg tablets are pale blue oval bi-convex tablets with OXB2.5 on one side. Ditropan 5 mg tablets are pale blue circular bi-convex tablets with OXB5 on one side and a break-line on the other side. Supplied in PVC/aluminium blisters in cartons containing 6, 21, or 84 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Neon Healthcare Ltd. 8 The Chase, John Tate Road, Hertford, SG13 7NN United Kingdom
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Manufacturer Sanofi Winthrop Industrie 30-36 avenue Gustave Eiffel 37000 Tours, France Fidelio Healthcare Limburg GmbH Mundipharmastraße 2 65549 Limburg an der Lahn Germany This leaflet was last revised in October 2023.
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Frequently asked questions about Ditropan 2.5mg Tablets
How do I take Ditropan 2.5mg Tablets?
Ditropan 2.5mg Tablets 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.
What is the active substance in Ditropan 2.5mg Tablets?
The active substance in Ditropan 2.5mg Tablets is oxybutynin hydrochloride.
Are there equivalent medicines to Ditropan 2.5mg Tablets?
Medicines with the same active substance, strength and form include: Oxybutynin Hydrochloride 2.5mg Tablets, Oxybutynin Hydrochloride Tablets 2.5 mg. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Ditropan 2.5mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Ditropan 2.5mg Tablets without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: oxybutynin hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Ditropan is indicated for the symptomatic treatment of 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
Ditropan is indicated in children of 5 years of age or older 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.
4.2. Posology and method of administration
Posology
The dosage should be determined individually.
Adults
The usual dose is 5 mg two or three times a day. This may be increased to a maximum of 5 mg four times a day (maximum dose 20 mg Oxybutynin hydrochloride per day) to obtain a clinical response provided that the side effects are tolerated.
Elderly
The elimination half-life is increased in the elderly. Therefore, a dose of 2.5 mg twice a day, particularly if the patient is frail, is likely to be adequate. This dose may be increased to 5 mg two times a day to obtain a clinical response provided the side effects are well tolerated.
Paediatric population
Children (under 5 years of age)
Ditropan is not recommended in children under 5 years of age due to the absence of data.
Children (5 years of age or older)
Neurogenic bladder instability: the usual dose is 2.5 mg twice a day. This dose may be increased to 5 mg 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 increased to 5 mg 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.
Method of administration
For oral use.
The tablets taste unpleasant and should therefore be swallowed with a glass of water.
4.3. Contraindications
- Hypersensitivity to the active substance or to any of the other excipients listed in section 6.1.
- Myasthenia gravis.
- Narrow-angle glaucoma or shallow anterior chamber.
- Gastrointestinal obstructive disorders including paralytic ileus, intestinal atony.
- Toxic megacolon.
- Severe ulcerative colitis.
- Bladder outflow obstruction where urinary retention may be precipitated.
4.4. Special warnings and precautions for use
- Ditropan 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.
- Ditropan 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 Ditropan 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.
- Ditropan 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 Ditropan 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 Ditropan 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 Ditropan in children with monosymptomatic nocturnal enuresis (not related to detrusor overactivity).
In children of 5 years of age or older, Ditropan should be used with caution as they may be more sensitive to the effects of the product, particularly the CNS and psychiatric adverse reactions.
Warnings on excipients
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
Care should be taken if other anticholinergic agents are administered together with Ditropan, 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, Ditropan 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.
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).
4.6. Fertility, pregnancy and lactation
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. Ditropan 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. Use of Ditropan during breast feeding is therefore not recommended.
4.7. Effects on ability to drive and use machines
Ditropan 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 medicine.
4.8. Undesirable effects
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
Common
palpitation
Not known
arrhythmia, tachycardia
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, 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
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms of intoxication
The symptoms of overdosage with Ditropan 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 micrograms/kg of physostigmine by slow intravenous administration. Repeat after 5 minutes, if necessary up to a maximum total dose of 2 mg.
Fever should be treated symptomatically with tepid sponging or ice packs.
In pronounced restlessness or excitation, diazepam 10 mg 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 about this leaflet
Ask anything about Ditropan 2.5mg 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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