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 Trospium chloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Regurin is a medicine used for the relaxation of the urinary bladder. It is used for the treatment of symptoms associated with involuntary loss of urine (wetting) and/or increased frequency of urination and imperative urge of urination in patients with hyperactive urinary bladder (involuntary urge of urination and voiding problems of unknown origin or due to nervous system disorders). 2.
What you need to take before you take Regurin
Do not take Regurin: − If you have ever had an allergic reaction to trospium chloride or any of the other ingredients of this medicine (listed in section 6). (An allergic reaction can be a rash, itchiness or shortness of breath). − If you suffer from any of the following: o urinary retention, i.e. blockage of the urinary tract, o the eye condition narrow-angle glaucoma, o abnormal/faster than normal heart beats, o myasthenia gravis (a disorder that causes muscle fatigue), o a severe gastro-intestinal condition, such as toxic megacolon. Warnings and precautions Talk to your doctor or pharmacist before taking Regurin If you suffer from any of the following: any type of stomach or bowel obstruction, an impaired urine flow ( e.g. in the case of benign tissue growth of the male prostrate), neuropathy i.e. nerve damage, hiatus hernia associated with reflux oesophagitis. This is usually associated with heartburn which worsens on bending or lying down, an overactive thyroid, any heart conditions, such as coronary artery disease or congestive heart failure, any liver problems, any kidney problems.
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If any of the above apply to you, it is important that you speak to your doctor or pharmacist before taking Regurin and they will decide what to do. Patients with liver disorders You should not take Regurin if you have a serious liver disorder. If you have a slight to moderate liver impairment you should talk to your doctor before taking this medicine. Patients with kidney disorders If you have a kidney disorder you should talk to your doctor before taking this medicine. He will, if necessary, give you a lower dose (see dosage instructions in Section 3 – How to take 'For patients with kidney disorders). Children under the age of 12 years Do not give Regurin to children under the age of 12 years. Other medicines and Regurin Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Inform your doctor in particular if you are taking any of the following medicines:
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This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say it is essentially 'sodium-free'. 3.
e Regurin 3. How to take Regurin 4. Possible side effects 5. How to store Regurin 6. Contents of the pack and further information 1.
Regurin
Always take Regurin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Usual dose unless otherwise prescribed by your doctor Unless otherwise prescribed by your doctor, the usual daily dose for adults and children over the age of 12 years is one Regurin tablet taken twice daily (equivalent to 40 mg of trospium chloride daily). Method of administration Swallow one tablet whole with a glass of water. Take the tablet before a meal on an empty stomach. Duration of treatment Your doctor will determine the duration of treatment. The need for continued treatment should be checked by your doctor at regular intervals of 3-6 months. For patients with kidney disorders If your kidney function is slightly to moderately impaired, no dose adjustment of Regurin is required. In severely impaired kidney function, the dose should be reduced to one tablet once daily or every second day (equivalent to 20 mg of trospium chloride daily or every second day). You should consult with your doctor about the correct dose for you. If you take more Regurin than you should No symptoms and signs of intoxication in humans have been reported to date. If you have taken more Regurin than the amount prescirbed you should contact your doctor or pharmacist immediately. If you forget to take Regurin If you miss a dose of Regurin, simply carry on with the next dose as usual. Do not take a double dose to make up for a forgotten dose. If you stop taking Regurin Your symptoms may return if you stop the intake of Regurin before recommended by your doctor. Therefore, you should take Regurin for as long as prescribed by your doctor. Please consult your doctor if you wish to stop treatment. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects occurring most frequently are typical for this kind of medicine and comprise dry mouth, dyspepsia and constipation. The following side effects below are serious and will require immediate action if you experience them. You should stop taking Regurin and see your doctor immediately if the following symptoms occur:
Very common side effects, affects more than 1 user in 10:
Regurin
Keep out of the sight and reach of children. Do not use Regurin after the expiry date which is stated on the carton and the blister foil after EXP. The expiry date refers to the last day of that month. Storage conditions This medicinal product does not require any special storage conditions. Do not use Regurin if you notice that the pack or any of the tablets are damaged. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
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6.
Contents of the pack and further information
What Regurin contains The active substance is trospium chloride Each coated tablet contains 20 mg trospium chloride. The other ingredients are: Tablet core: Wheat starch, microcrystalline cellulose, lactose monohydrate, povidone (K29-32), croscarmellose sodium, stearic acid, silica colloidal anhydrous, talc. Tablet coating: Sucrose, carmellose sodium, talc, silica colloidal anhydrous, calcium carbonate (E 170), macrogol 8000, titanium dioxide (E 171), iron oxide hydrate yellow (E 172), white beeswax, carnauba wax. See section 2 'Regurin contains lactose, sucrose, wheat and sodium' What Regurin looks like and contents of the pack Regurin tablets are brownish-yellow, glossy coated tablets with a diameter of approximately 7 mm. Regurin is available in packs containing 2, 20, 28, 30, 50, 56, 60, 90, 100, 120, 150, 200, 500, 600, 1000, 1200 and 2000 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Viatris Products Limited, Station Close, Potters Bar, EN6 1TL, United Kingdom. Manufacturer Madaus GmbH Luetticher Str. 5 53842 Troisdorf Germany This leaflet was last revised in 02/2026. Regurin is a registered trade mark of Madaus GmbH.
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Regurin 20 mg Coated Tablets comes as tablet containing 20mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Regurin 20 mg Coated Tablets is trospium chloride.
Medicines with the same active substance, strength and form include: Trospium chloride 20mg film-coated tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Regurin 20 mg 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 (e.g. idiopathic or neurologic detrusor overactivity).
Posology
One coated tablet twice daily (equivalent to 40 mg of trospium chloride per day).
Patients with renal impairment:
In patients with severe renal impairment (creatinine clearance between 10 and 30 mL/min/1.73 m2) the recommended dosage is: One coated tablet per day or every second day (equivalent to 20 mg of trospium chloride per day or every second day).
Regurin is contraindicated in children aged under 12 years
Method of administration
The coated tablet should be swallowed whole with a glass of water before the meals on empty stomach.
The need for continued treatment should be reassessed at regular intervals of 3-6 months.
Trospium chloride is contraindicated in patients with urinary retention, severe gastro-intestinal condition (including toxic megacolon), myasthenia gravis, narrow-angle glaucoma, and tachyarrhythmia.
Trospium chloride is also contraindicated in patients who have demonstrated hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Trospium chloride should be used with caution by patients:
- with obstructive conditions of the gastrointestinal tract such as pyloric stenosis
- with obstruction of the urinary flow with the risk of formation of urinary retention with autonomic neuropathy
- with hiatus hernia associated with reflux oesophagitis
- in whom fast heart rates are undesirable e.g. those with hyperthyroidism, coronary artery disease and congestive heart failure.
As there are no data in patients with severe hepatic impairment, treatment of these patients with trospium chloride is not recommended. In patients with mild to moderate liver impairment caution should be exercised.
Trospium chloride is mainly eliminated by renal excretion. Marked elevations in the plasma levels have been observed in patients with severe renal impairment. Therefore in this population but also in patients with mild to moderate renal impairment caution should be exercised (see section 4.2).
Before commencing therapy organic causes of urinary frequency, urgency, and urge incontinence, such as heart diseases, diseases of the kidneys, polydipsia, or infections, or tumours of urinary organs should be excluded.
Excipients
This medicinal product contains lactose and sucrose. Patients with rare hereditary problems of galactose intolerance, fructose intolerance, total Lapp lactase deficiency, glucose-galactose malabsorption or sucrase‑isomaltase insufficiency should not take this medicinal product.
This medicinal product contains no more than 57 micrograms of gluten in each coated tablet. It is very unlikely to adversely affect patients with coeliac disease. Patients with wheat allergy (different from coeliac disease) should not take this medicinal product.
This medicinal product contains less than 1 mmol sodium (23 mg) per coated tablet, that is to say it is essentially 'sodium-free'.
Pharmacodynamic interactions:
The following potential pharmacodynamic interactions may occur: Potentiation of the effect of drugs with anticholinergic action (such as amantadine, tricyclic antidepressants), enhancement of the tachycardic action of ß-sympathomimetics, decrease in efficacy of pro-kinetic agents (e.g. metoclopramide).
Since trospium chloride may influence gastro-intestinal motility and secretion, the possibility cannot be excluded that the absorption of other concurrently administered drugs may be altered.
Pharmacokinetic interactions:
An inhibition of the absorption of trospium chloride with drugs like guar, colestyramine and colestipol cannot be excluded. Therefore the simultaneous administration of these drugs with trospium chloride is not recommended.
Metabolic interactions of trospium chloride have been investigated in vitro on cytochrome P450 enzymes involved in drug metabolism (P450 1A2, 2A6, 2C9, 2C19, 2D6, 2E1, 3A4). No influence on their metabolic activities was observed. Since trospium chloride is metabolised only to a low extent and since ester hydrolysis is the only relevant metabolic pathway, no metabolic interactions are expected.
Though trospium chloride was shown not to affect pharmacokinetics of digoxin, an interaction with other active substances eliminated by active tubular secretion cannot be excluded.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). In rats, placental transfer and passage into the maternal milk of trospium chloride occurs.
For Regurin 20 mg no clinical data on exposed pregnancies are available.
Caution should be exercised when prescribing to pregnant or breastfeeding women.
Principally, disorders of accommodation can lower the ability to actively participate in road traffic and to use machines.
However, examinations of parameters characterising the ability to participate in road traffic (visual orientation, general ability to react, reaction under stress, concentration and motor coordination) have not revealed any effects of trospium chloride.
Undesirable effects observed with trospium chloride such as dry mouth, dyspepsia and constipation mainly reflect the typical anticholinergic properties of the active ingredient.
In Phase-III clinical studies, dry mouth was very common and occurred in approximately 18% of patients treated with trospium chloride and in approximately 6% treated with placebo (total of 1931 patients of which 911 received placebo).
The following table lists possibly related drug reactions reported for patients treated with Regurin 20 mg:
Very common
(>1/10)
Common
(≥1/100,<1/10)
Uncommon
(≥1/1000, <1/100)
Rare
(≥1/10.000, <1/1000)
Very Rare
(<1/10.000)
Not known (cannot be estimated from the available data)
Cardiac disorders
Tachycardia
Tachyarrhythmia
Nervous system disorders
Headache
Dizziness
Hallucination*
confusion*
agitation*
Eye disorders
Vision disorders
Respiratory, thoracic and mediastinal disorders
Dyspnoea
Gastrointestinal disorders
Dry mouth
Dyspepsia
Constipation
Abdominal pain
Nausea
Flatulence
Diarrhoea
Renal and urinary disorders
Micturition disorders
Urinary retention
Skin and subcutaneous disorders
Rash
Angio-oedema
Pruritus
Urticaria
Stevens-Johnson Syndrome (SJS) / Toxic Epidermal Necrolysis (TEN)
Muscoskeletal and connective tissue disorders
Myalgia
Arthralgia
General disorders and administration site conditions
Chest pain
Asthenia
Immune system disorders
Anaphylaxis
Investigations
Mild to moderate increase in serum transaminase levels
*These adverse effects occurred mostly in elderly patients and can be facilitated by neurological diseases and/or concomitant intake of other anticholinergic drugs (see section 4.5).
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 Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard
After the administration of a maximum single dose of 360 mg trospium chloride to healthy volunteers, dryness of the mouth, tachycardia and disorders of micturition were observed to an increased extent. No manifestations of severe overdosage or intoxication in humans have been reported to date. Increased anticholinergic symptoms are to be expected as signs of intoxication.
In the case of intoxication the following measures should be taken:
- gastric lavage and reduction of absorption (e.g. activated charcoal)
- local administration of pilocarpine to glaucoma patients
- catheterisation in patients with urinary retention
- treatment with a parasympathomimetic agent (e.g. neostigmine) in the case of severe symptoms
- administration of beta blockers in the case of insufficient response, pronounced tachycardia and/or circulatory instability (e.g. initially 1 mg propranolol intravenously along with monitoring of ECG and blood pressure).
Ask anything about Regurin 20 mg 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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