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.
Detrusitol XL 4mg prolonged-release capsules, hard
⚠ 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 Tolterodine tartrate 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 The active substance in Detrusitol XL is tolterodine. Tolterodine belongs to a class of medicinal products called antimuscarinics. Detrusitol XL is used for the treatment of the symptoms of overactive bladder syndrome. If you have overactive bladder syndrome, you may find that:
- you are unable to control urination,
- you need to rush to the toilet with no advance warning and/or go to the toilet frequently.
What you need to know before you take it
e DETRUSITOL XL Do not take Detrusitol XL if you: • • • • • •
are allergic (hypersensitive) to tolterodine or any of the other ingredients in Detrusitol XL are unable to pass urine from the bladder (urinary retention) have an uncontrolled narrow-angle glaucoma (high pressure in the eyes with loss of eyesight that is not being adequately treated) suffer from myasthenia gravis (excessive weakness of the muscles) suffer from severe ulcerative colitis (ulceration and inflammation of the colon) suffer from a toxic megacolon (acute dilatation of the colon).
Warnings and precautions Page 1 of 7
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• • • • • • • •
•
If you have difficulties in passing urine and/or a poor stream of urine If you have a gastro-intestinal disease that affects the passage and/or digestion of food If you suffer from kidney problems (renal insufficiency) If you have a liver condition If you suffer from neuronal disorders that affect your blood pressure, bowel or sexual function (any neuropathy of the autonomic nervous system) If you have a hiatal hernia (herniation of an abdominal organ) If you ever experience decreased bowel movements or suffer from severe constipation (decreased gastro-intestinal motility) If you have a heart condition such as: ▪ an abnormal heart tracing (ECG); ▪ a slow heart rate (bradycardia); ▪ relevant pre-existing cardiac diseases such as:
- cardiomyopathy (weak heart muscle)
- myocardial ischaemia (reduced blood flow to the heart)
- arrhythmia (irregular heartbeat)
- and heart failure If you have abnormally low levels of potassium (hypokalaemia), calcium (hypocalcaemia) or magnesium (hypomagnesaemia) in your blood.
Talk to your doctor or pharmacist before starting your treatment with Detrusitol XL if you think any of these might apply to you. Other medicines and Detrusitol XL Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Tolterodine, the active substance of Detrusitol XL, may interact with other medicinal products. It is not recommended to use tolterodine in combination with:
- some antibiotics (containing e.g. erythromycin, clarithromycin)
- medicinal products used for the treatment of fungal infections (containing e.g. ketoconazole, itraconazole)
- medicinal products used for the treatment of HIV. Detrusitol XL should be used with caution when taken in combination with:
- medicines that affect the passage of food (containing e.g. metoclopramide and cisapride)
- medicines for the treatment of irregular heartbeat (containing e.g. amiodarone, sotalol, quinidine, procainamide)
- other medicines with a similar mode of action to Detrusitol XL (antimuscarinic properties) or medicines with an opposite mode of action to Detrusitol XL (cholinergic properties). Ask your doctor if you are unsure. Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Page 2 of 7
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Detrusitol XL with food and drink Detrusitol XL can be taken before, after or during a meal. Pregnancy and breast-feeding Pregnancy You should not use Detrusitol XL when you are pregnant. Tell your doctor immediately if you are pregnant, think you are pregnant or are planning to become pregnant. Breast-feeding It is not known if tolterodine, the active substance of Detrusitol XL, is excreted in the mother's breast milk. Breast-feeding is not recommended during administration of Detrusitol XL. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Detrusitol XL may make you feel dizzy, tired or affect your sight; your ability to drive or operate machinery may be affected. Detrusitol XL contains sucrose (a type of sugar) If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
How to take it
DETRUSITOL XL Dosage Always take Detrusitol XL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is one 4 mg prolonged-release capsule daily, except for patients who have a kidney or a liver condition or troublesome side effects, in which case your doctor may reduce your dose to one 2 mg Detrusitol daily. Detrusitol XL is not recommended for children. The prolonged-release capsules are for oral use and should be swallowed whole. Do not chew the capsules. Duration of treatment Your doctor will tell you how long your treatment with Detrusitol XL will last. Do not stop treatment early because you do not see an immediate effect. Your bladder will need some time to adapt. Finish the course of prolonged-release capsules prescribed by your doctor. If you have not noticed any effect by then, talk to your doctor. The benefit of the treatment should be re-evaluated after 2 or 3 months. Page 3 of 7
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Always consult your doctor if you are thinking of stopping the treatment. If you take more Detrusitol XL than you should If you or somebody else takes too many prolonged-release capsules, contact your doctor or pharmacist immediately. If you forget to take Detrusitol XL If you forget to take a dose at the usual time, take it as soon as you remember unless it is almost time for your next dose. In that case, omit the forgotten dose and follow the normal dose schedule. Do not take a double dose to make up for a forgotten one. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. You should see your doctor immediately or go to the casualty department if you experience symptoms of angioedema, such as:
- swollen face, tongue or pharynx
- difficulty to swallow
- hives and difficulty in breathing You should also seek medical attention if you experience a hypersensitivity reaction (for example itching, rash, hives, difficulty breathing). This occurs uncommonly (occurs in less than 1 in 100 patients). Tell your doctor immediately or go to the casualty department if you notice any of the following:
- chest pain, difficulty breathing or getting tired easily (even at rest), difficulty breathing at night, swelling of the legs. These may be symptoms of heart failure. This occurs uncommonly (occurs in less than 1 in 100 patients). The following side effects have been observed during treatment with Detrusitol XL with the following frequencies. Very common: may affect more than 1 in 10 people
- Dry mouth Common: may affect up to 1 in 10 people
- Sinusitis
- Dizziness, sleepiness, headache
- Dry eyes, blurred vision
- Difficulty with digestion (dyspepsia), constipation, abdominal pain, excessive amounts of air or gases in the stomach or the intestine Page 4 of 7
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• • • •
Painful or difficult urination Tiredness Extra fluid in the body causing swelling (e.g. in the ankles) Diarrhoea
Uncommon: may affect up to 1 in 100 people
- Allergic reactions
- Nervousness
- Sensation of pins and needles in the fingers and toes
- Vertigo
- Palpitations, heart failure, irregular heartbeat
- Inability to empty the bladder
- Chest pain
- Memory impairment Additional reactions reported include severe allergic reactions, confusion, hallucinations, increased heart rate, flushed skin, heart burn, vomiting, angioedema, dry skin, and disorientation. There have also been reports of worsening symptoms of dementia in patients being treated for dementia. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 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. By reporting
Possible side effects
you can help provide more information on the safety of this medicine.
How to store it
DETRUSITOL XL Keep this medicine out of the sight and reach of children. Do not use Detrusitol XL after the expiry date which is stated on the label/carton. The expiry date refers to the last day of that month. Do not store above 25 oC. Bottle: Store in the original container. Blisters: Keep the blister in the outer carton. 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. Page 5 of 7
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Contents of the pack and other information
What Detrusitol XL contains The active substance in Detrusitol XL 4 mg prolonged-release capsules is 4 mg of tolterodine tartrate, equivalent to 2.74 mg of tolterodine. The other ingredients are: Capsule contents: Sugar spheres (containing sucrose and maize starch ) [See section 2 Detrusitol XL contains sucrose (a type of sugar)], hypromellose and Surelease E-719040 (containing ethylcellulose, medium chain triglycerides and oleic acid). Capsule shell: Gelatine and colourants. Colourants: Blue 4 mg prolonged-release capsule: Indigo carmine (E132) and titanium dioxide (E171). Printing ink: Shellac glaze (E904), titanium dioxide (E171), propylene glycol (E1520) and simeticone. What Detrusitol XL looks like and contents of the pack Detrusitol XL is a hard prolonged-release capsule designed for once daily dosing. Detrusitol XL 4 mg prolonged-release capsules are blue and marked with white printing (symbol and 4). Detrusitol XL 4 mg prolonged-release capsules are available in the following pack sizes: Blister packs containing:
- 7 prolonged-release capsules
- 14 prolonged-release capsules
- 28 prolonged-release capsules
- 49 prolonged-release capsules
- 84 prolonged-release capsules
- 98 prolonged-release capsules
- 280 prolonged-release capsules And bottles containing 30, 100 and 200 capsules. Hospital packs are available in packs of 80, 160 and 320 capsules. Please note that not all the above pack sizes may be marketed.
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Marketing Authorisation Holder and Manufacturer Viatris Products Limited, Station Close, Potters Bar, EN6 1TL, United Kingdom. Manufacturer: Pfizer Italia S.r.l Località Marino del Tronto 63100 Ascoli Piceno (AP) Italy Or MEDIS INTERNATIONAL a.s., výrobní závod Bolatice Průmyslová 961/16 747 23 Bolatice Czech Republic This leaflet was last revised: 06/2026.
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Frequently asked questions about Detrusitol XL 4mg prolonged-release capsules, hard
How do I take Detrusitol XL 4mg prolonged-release capsules, hard?
Detrusitol XL 4mg prolonged-release capsules, hard comes as capsule containing 4mg. 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 Detrusitol XL 4mg prolonged-release capsules, hard?
The active substance in Detrusitol XL 4mg prolonged-release capsules, hard is tolterodine tartrate.
Are there equivalent medicines to Detrusitol XL 4mg prolonged-release capsules, hard?
Medicines with the same active substance, strength and form include: Neditol XL 4mg, prolonged-release capsules, hard. 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 Detrusitol XL 4mg prolonged-release capsules, hard, 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 Detrusitol XL 4mg prolonged-release capsules, hard 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: tolterodine tartrate
- 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
Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.
4.2. Posology and method of administration
Adults (including the elderly)
The recommended dose is 4 mg once daily except in patients with impaired liver function or severely impaired renal function (GFR ≤ 30 ml/min) for whom the recommended dose is 2 mg once daily (see sections 4.4 and 5.2). In case of troublesome side-effects the dose may be reduced from 4 mg to 2 mg once daily.
The prolonged-release capsules can be taken with or without food and must be swallowed whole.
The effect of treatment should be re-evaluated after 2-3 months (see section 5.1).
Paediatric population
Efficacy of Detrusitol XL has not been demonstrated in children (see section 5.1). Therefore, Detrusitol XL is not recommended for children.
4.3. Contraindications
Tolterodine is contraindicated in patients with
- Urinary retention
- Uncontrolled narrow angle glaucoma
- Myasthenia gravis
- Known hypersensitivity to tolterodine or excipients (see section 6)
- Severe ulcerative colitis
- Toxic megacolon
4.4. Special warnings and precautions for use
Tolterodine shall be used with caution in patients with
- Significant bladder outlet obstruction at risk of urinary retention
- Gastrointestinal obstructive disorders, e.g. pyloric stenosis
- Renal impairment (see sections 4.2 and 5.2)
- Hepatic disease (see sections 4.2 and 5.2)
- Autonomic neuropathy
- Hiatus hernia
- Risk of decreased gastrointestinal motility
Multiple oral total daily doses of immediate release 4 mg (therapeutic) and 8 mg (supratherapeutic) tolterodine have been shown to prolong the QTc interval (see section 5.1). The clinical relevance of these findings is unclear and will depend on individual patient risk factors and susceptibilities present.
Tolterodine should be used with caution in patients with risk factors for QT prolongation including:
- Congenital or documented acquired QT prolongation
- Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia
- Bradycardia
- Relevant pre-existing cardiac diseases (i.e. cardiomyopathy, myocardial ischaemia, arrhythmia, congestive heart failure)
- Concomitant administration of drugs known to prolong QT-interval including Class IA (e. g. quinidine, procainamide) and Class III (e. g. amiodarone, sotalol) anti-arrhythmics.
This especially holds true when taking potent CYP3A4 inhibitors (see section 5.1).
Concomitant treatment with potent CYP3A4 inhibitors should be avoided (see section 4.5).
Urinary retention
As with all treatments for symptoms of urgency and urge incontinence, organic reasons for urge and frequency should be considered before treatment.
Excipient information
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
4.5. Interaction with other medicinal products and other forms of interaction
Concomitant systemic medication with potent CYP3A4 inhibitors such as macrolide antibiotics (erythromycin and clarithromycin), antifungal agents (e.g. ketoconazole and itraconazole) and antiproteases is not recommended due to increased serum concentrations of tolterodine in poor CYP2D6 metabolisers with (subsequent) risk of overdosage (see section 4.4).
Concomitant medication with other drugs that possess antimuscarinic properties may result in more pronounced therapeutic effect and side-effects. Conversely, the therapeutic effect of tolterodine may be reduced by concomitant administration of muscarinic cholinergic receptor agonists.
The effect of prokinetics like metoclopramide and cisapride may be decreased by tolterodine.
Concomitant treatment with fluoxetine (a potent CYP2D6 inhibitor) does not result in a clinically significant interaction since tolterodine and its CYP2D6-dependent metabolite, 5-hydroxymethyl tolterodine are equipotent.
Drug interaction studies have shown no interactions with warfarin or combined oral contraceptives (ethinyl estradiol/levonorgestrel).
A clinical study has indicated that tolterodine is not a metabolic inhibitor of CYP2D6, 2C19, 2C9, 3A4 or 1A2. Therefore an increase of plasma levels of drugs metabolised by these isoenzymes is not expected when dosed in combination with tolterodine.
4.6. Pregnancy and lactation
Pregnancy
There are no adequate data from the use of tolterodine in pregnant women.
Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown.
Consequently, Detrusitol XL is not recommended during pregnancy.
Breast-feeding
No data concerning the excretion of tolterodine into human milk are available. Tolterodine should be avoided during lactation.
4.7. Effects on ability to drive and use machines
Since this drug may cause accommodation disturbances and influence reaction time, the ability to drive and use machines may be negatively affected.
4.8. Undesirable effects
Summary of the safety profile
Due to the pharmacological effect of tolterodine it may cause mild to moderate antimuscarinic effects, like dryness of the mouth, dyspepsia and dry eyes.
Table 1 below reflects the data obtained with Detrusitol XL in clinical trials and from post marketing experience. The most commonly reported adverse reaction was dry mouth, which occurred in 23.4 % of patients treated with Detrusitol XL and in 7.7 % of placebo-treated patients.
Tabulated list of adverse reactions
The adverse drug reactions listed in the table below are presented by System Organ Class (SOC) and frequency categories, defined using the following convention: 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), or not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Table 1: Adverse drug reactions
System organ class
Very Common
(≥1/10)
Common
(≥ 1/100 to <1/10)
Uncommon
(≥ 1/1000 to <1/100)
Not known
(cannot be estimated from the available data)
Infections and infestations
Sinusitis
Immune system disorders
Hypersensitivity not otherwise specified
Anaphylactoid reactions
Psychiatric disorders
Nervousness
Confusion, hallucinations, disorientation
Nervous system disorders
Dizziness, somnolence, headache
Paresthesia, memory impairment
Eye disorders
Dry eyes, abnormal vision (including abnormal accommodation)
Ear and labyrinth disorders
Vertigo
Cardiac disorders
Palpitations, cardiac failure, arrhythmia
Tachycardia
Vascular disorders
Flushing
Gastrointestinal disorders
Dry mouth
Dyspepsia, constipation, abdominal pain, flatulence, diarrhoea
Gastroesophageal reflux, vomiting
Skin and subcutaneous tissue disorders
Angioedema, dry skin
Renal and urinary disorders
Dysuria
Urinary retention
General disorders and administration site conditions
Fatigue, peripheral oedema
Chest pain
Cases of aggravation of symptoms of dementia (e.g. confusion, disorientation, delusion) have been reported after tolterodine therapy was initiated in patients taking cholinesterase inhibitors for the treatment of dementia.
Paediatric population
In two paediatric phase 3 randomised, placebo-controlled, double-blind studies conducted over 12 weeks where a total of 710 paediatric patients were recruited, the proportion of patients with urinary tract infections, diarrhoea and abnormal behaviour was higher in patients treated with tolterodine than placebo (urinary tract infection: tolterodine 6.8 %, placebo 3.6 %; diarrhoea: tolterodine 3.3 %, placebo 0.9 %; abnormal behaviour: tolterodine 1.6 %, placebo 0.4 %). (see section 5.1)
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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
The highest dose given to human volunteers of tolterodine tartrate is 12.8 mg as a single dose of the immediate release formulation. The most severe adverse events observed were accommodation disturbances and micturition difficulties.
In the event of tolterodine overdose, treat with gastric lavage and give activated charcoal. Treat symptoms as follows:
- Severe central anticholinergic effects (e.g. hallucinations, severe excitation): treat with physostigmine
- Convulsions or pronounced excitation: treat with benzodiazepines
- Respiratory insufficiency: treat with artificial respiration
- Tachycardia: treat with beta-blockers
- Urinary retention: treat with catheterisation
- Mydriasis: treat with pilocarpine eye drops and/or place patient in dark room
An increase in QT interval was observed at a total daily dose of 8 mg immediate release tolterodine (twice the recommended daily dose of the immediate release formulation and equivalent to three times the peak exposure of the prolonged release capsule formulation) administered over four days. In the event of tolterodine overdose, standard supportive measures for managing QT prolongation should be adopted.
💬 Ask about this leaflet
Ask anything about Detrusitol XL 4mg prolonged-release capsules, hard. 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.