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 Tolterodine tartrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for The active substance in Detrusitol is tolterodine. Tolterodine belongs to a class of medicinal products called antimuscarinics. Detrusitol is used for the treatment of the symptoms of overactive bladder syndrome. If you have overactive bladder syndrome, you may find that:
e DETRUSITOL Do not take Detrusitol if you: • • • • • •
are allergic (hypersensitive) to tolterodine or any of the other ingredients in Detrusitol (listed in section 6) 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).
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Warnings and precautions
• • • • • • • •
•
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:
Talk to your doctor or pharmacist before starting your treatment with Detrusitol if you think any of these might apply to you. Other medicines and Detrusitol
Tolterodine, the active substance of Detrusitol, may interact with other medicinal products. It is not recommended to use tolterodine in combination with:
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Detrusitol with food and drink Detrusitol can be taken before, after or during a meal. Pregnancy and breast-feeding Pregnancy You should not use Detrusitol 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, is excreted in the mother's breast milk. Breast-feeding is not recommended during administration of Detrusitol. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Detrusitol may make you feel dizzy, tired or affect your sight; your ability to drive or operate machinery may be affected. Detrusitol contains sodium Detrusitol contains less than 1 mmol sodium (23 mg) per 1 mg and 2 mg film-coated tablets, that is to say essentially 'sodium-free'.
DETRUSITOL Dosage Always take Detrusitol 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 2 mg tablet twice 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 1 mg tablet twice daily. Detrusitol is not recommended for children. The tablets are for oral use and should be swallowed whole. Duration of treatment Your doctor will tell you how long your treatment with Detrusitol 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 tablets 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. Always consult your doctor if you are thinking of stopping the treatment. If you take more Detrusitol than you should: If you or somebody else takes too many tablets, contact your doctor or pharmacist immediately.
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If you forget to take Detrusitol 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.
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:
• • •
Tiredness, chest pain, extra fluid in the body causing swelling (e.g. in the ankles) Increased weight Diarrhoea
Uncommon: may affect up to 1 in 100 people
DETRUSITOL 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 label/carton. The expiry date refers to the last day of that month. No special precautions for storage. Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away of medicines you no longer use. These measures will help to protect the environment.
What Detrusitol contains The active substance in Detrusitol 1 mg tablets is tolterodine. Each tablet contains 1 mg of tolterodine tartrate, equivalent to 0.68 mg of tolterodine. The active substance in Detrusitol 2 mg tablets is tolterodine. Each tablet contains 2 mg of tolterodine tartrate, equivalent to 1.37 mg of tolterodine.
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The other ingredients are: Core: Microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium starch glycollate (Type B) (See section 2 "Detrusitol contains sodium"), magnesium stearate and colloidal anhydrous silica. Film coating: Hypromellose, microcrystalline cellulose, stearic acid and titanium dioxide (E171). What Detrusitol looks like and contents of the pack Detrusitol 1 mg tablets are white, round, biconvex and marked with arcs above and below the lettering TO. Detrusitol 2 mg tablets are white, round, biconvex and marked with arcs above and below the lettering DT. Detrusitol 1 mg and 2 mg tablets are available in the following pack sizes: Blister packs containing;
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This leaflet was last revised in January 2026. Ref: DT 16_0
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Detrusitol 2 mg film-coated tablets comes as tablet containing 2mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Detrusitol 2 mg film-coated tablets is tolterodine tartrate.
Medicines with the same active substance, strength and form include: Tolterodine tartrate 2mg film-coated tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Detrusitol 2 mg film-coated 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.
Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.
Adults (including elderly:
The recommended dose is 2 mg twice daily except in patients with impaired liver function or severely impaired renal function (GFR ≤30 ml/min) for whom the recommended dose is 1 mg twice daily (see section 4.4). In case of troublesome side effects the dose may be reduced from 2 mg to 1 mg twice daily.
The effect of treatment should be re-evaluated after 2-3 months (see section 5.1).
Paediatric population
Efficacy of Detrusitol has not been demonstrated in children (ssection 5.1). Therefore, Detrusitol is not recommended for children.
Tolterodine is contraindicated in patients with
- Urinary retention
- Uncontrolled narrow angle glaucoma
- Myasthenia gravis
- Known hypersensitivity to tolterodine or excipients (see section 6.1)
- Severe ulcerative colitis
- Toxic megacolon
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 section 4.2)
- Hepatic disease. (see section 4.2 and 5.2)
- Autonomic neuropathy
- Hiatus hernia
- Risk for 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
Detrusitol 2 mg tablets contain less than 1 mmol sodium (23 mg) per tablet. Patients on low sodium diets can be informed that this medicinal product is essentially 'sodium-free'.
Concomitant systemic medication with potent CYP3A4 inhibitors such as macrolide antibiotics (e.g. 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.
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 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.
Since this drug may cause accommodation disturbances and influence reaction time, the ability to drive and use machines may be negatively affected.
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 in clinical trials and from postmarketing experience. The most commonly reported adverse reaction was dry mouth, which occurred in 35% of patients treated with Detrusitol tablets and in 10% of placebo treated patients. Headaches were also reported very commonly and occurred in 10.1% of patients treated with Detrusitol tablets and in 7.4% 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
Bronchitis
Immune system disorders
Hypersensitivity not otherwise specified
Anaphylactoid reactions
Psychiatric disorders
Nervousness
Confusion, hallucinations, disorientation
Nervous system disorders
Headaches
Dizziness, somnolence, paresthesia
Memory impairment
Eye disorders
Dry eyes, abnormal vision including abnormal accommodation
Ear and labyrinth disorders
Vertigo
Cardiac disorders
Palpitations
Tachycardia, cardiac failure, arrhythmia
Vascular disorders
Flushing
Gastrointestinal disorders
Dry mouth
Dyspepsia, constipation, abdominal pain, flatulence, vomiting, diarrhoea
Gastroesophageal reflux
Skin and subcutaneous tissue disorders
Dry skin
Angioedema
Renal and urinary disorders
Dysuria, urinary retention
General disorders and administration site conditions
Fatigue, chest pain, peripheral oedema
Investigations
Increased weight
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 populationIn two paediatric phase III 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
The highest dose given to human volunteers of tolterodine tartrate is 12.8 mg as a single dose. 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 anything about Detrusitol 2 mg film-coated 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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