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.
Trospium chloride 20mg film-coated 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 Trospium chloride 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
Trospium chloride 20mg film-coated tablets 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 bladder (involuntary urge of urination and voiding problems of unknown origin or due to nervous system disorders).
2.
What you need to know before you take it
e Trospium chloride 20mg film-coated tablets
Do not take Trospium chloride 20mg film-coated tablets if you are allergic 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: urinary retention, i.e. blockage of the urinary tract the eye condition narrow-angle glaucoma abnormal/faster than normal heart beats myasthenia gravis (a disorder that causes muscle fatigue) a severe gastro-intestinal condition, such as toxic megacolon.
Warnings and precautions Talk to your doctor or your pharmacist before taking Trospium chloride 20mg film-coated tablets 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 prostate) neuropathy i.e. nerve damage
a 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 (see "Patients with liver disorders" below) any kidney problems (see "Patients with kidney disorders" below).
Patients with liver disorders You should not take Trospium chloride 20mg film-coated tablets 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. Your doctor will, if necessary, give you a lower dose (see dosage instructions in Section 3"How to take Trospium chloride 20mg film-coated tablets – Patients with kidney disorders"). Children under 12 years of age The safety and efficacy of [Name to be completed nationally] in children under 12 years of age has not been established. No data are available. Other medicines and Trospium chloride 20mg film-coated tablets 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: certain medicines for the treatment of abnormal sadness (depression), e.g. amitriptyline or imipramine medicines for the treatment of asthma that may accelerate the heart rate (e.g. salbutamol) other medicines with anticholinergic action (e.g. amantadine) medicines for the stimulation of motility of the gastro-intestinal tract which are used to treat impaired gastric emptying or complaints due to reflux of gastric acid (reflux disease), e.g. metoclopramide medicines containing the substances guar, colestipol or cholestyramine which should not be taken simultaneously with Trospium chloride 20mg film-coated tablets. If you are unsure of the types of medicines you are taking, ask your doctor or pharmacist. Trospium chloride 20mg film-coated tablets with food and drink As high fat diets can affect the action of Trospium chloride 20mg film-coated tablets, this medicine should be taken before meals on an empty stomach. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Since there is no experience with trospium chloride during pregnancy and breast-feeding, Trospium chloride 20mg film-coated tablets should be taken during pregnancy and breast-feeding only if your doctor considers it absolutely necessary.
Driving and using machines This medicine can cause blurred vision. Do not drive motor vehicles, operate machines or perform other hazardous activities if you suffer from blurred vision after taking this medicine.
Trospium chloride 20mg film-coated tablets contain lactose (milk sugar) and sucrose (sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3.
How to take it
Trospium chloride 20mg film-coated tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Dosage The recommended dose for adults and children over 12 years of age is one film-coated tablet twice a day (equivalent to 40 mg of trospium chloride per day), unless otherwise prescribed by your doctor. Patients with kidney disorders If your kidney function is slightly to moderately impaired, no dose adjustment 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. Use in children Do not give this medicine to children under 12 years of age. Method of administration (How to take the tablets) Swallow one film-coated tablet whole with a glass of water. Take the tablet before a meal on an empty stomach. Duration of treatment Your doctor will want to assess your treatment every 3 to 6 months, to decide whether this medicine is still the best one for you. If you take more Trospium chloride 20mg film-coated tablets than you should No symptoms and signs of intoxication in humans have been reported to date. If you have taken more Trospium chloride 20mg film-coated tablets than the amount prescribed, you should contact a doctor or pharmacist immediately. If you forget to take Trospium chloride 20mg film-coated tablets If you miss a dose of Trospium chloride 20mg film-coated tablets, 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 Trospium chloride 20mg film-coated tablets Your symptoms may return if you stop the intake of Trospium chloride 20mg film-coated tablets before recommended by your doctor. Therefore, you should take this medicine 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.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects below are serious and will require immediate action if you experience them. Stop taking Trospium chloride 20mg film-coated tablets and see your doctor immediately if the following symptoms occur: swelling of the face, tongue and windpipe which can cause great difficulty in breathing (very rare side effect, affects less than 1 in 10,000 patients) a sudden allergic reaction with shortness of breath, rash, itchiness, wheezing and drop of blood pressure (frequency of this side effect is unknown) life-threatening hypersensitivity reactions with large-scale detachment of the skin and/or mucous membranes (frequency of this side effect is unknown). The following side effects have also been reported for Trospium chloride 20mg film-coated tablets: Very common side effects (affects more than 1 user in 10):
dryness of the mouth
Common side effects (affects 1 to 10 users in 100):
indigestion (dyspepsia) constipation abdominal pain feeling sick (nausea)
Uncommon side effects (affects 1 to 10 users in 1,000):
fast heart beat (tachycardia) headache wind (flatulence) diarrhoea chest pain
Rare side effects (affects 1 to 10 users in 10,000):
dizziness difficulty seeing objects close-up / blurred vision difficulty emptying the bladder, urinary retention rash joint pain (arthralgia) muscle pain (myalgia)
Other possible side effects, for which the frequency is unknown (cannot be estimated from the available data) accelerated and irregular heart rate (tachyarrhythmia) difficulty in breathing (dyspnoea) itchiness, nettle rash (hives, urticaria) general feeling of weakness (asthenia) slight to moderate increase of certain liver values (serum transaminases) sporadic cases of hallucinations, confusion and agitation have occurred mostly in elderly patients and can be facilitated by neurological diseases and/or other drugs, with a similar mechanism of action taken at the same time. 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 Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store it
Trospium chloride 20mg film-coated tablets
Keep this medicine out of the sight and reach of children. Do not use Trospium chloride 20mg film-coated tablets after the expiry date which is stated on the blister and on the carton after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. 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.
6.
Contents of the pack and other information
WhatTrospium chloride 20mg film-coated tablets contain The active substance is trospium chloride. Each film-coated tablet contains 20 mg trospium chloride. The other ingredients are : Core: Cellulose Microcrystalline, Lactose monohydrate, Maize starch, Povidone, Croscarmellose sodium, Silica Colloidal Anhydrous, Magnesium Stearate; Coating: Sucrose, Copovidone, Titanium Dioxide (E171), Macrogol 6000, Macrogol 400, Talc, Hypromellose (E464), Iron Oxide Yellow (E172), Iron Oxide Red (E172). What Trospium chloride 20mg film-coated tablets look like and contents of the pack Trospium chloride 20mg film-coated tablets are supplied as:
brownish yellow to light brown, round, biconvex film-coated tablets, debossed with "L" on one side and "l" on other side. Trospium chloride 20mg film-coated tablets are available in PVC/PVDC-Aluminium blisters of 30, 50, 60, 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Glenmark Pharmaceuticals Europe Limited Laxmi House, 2B Draycott Avenue Harrow, MiddlesexHA3 0BU, UK Manufacturers: Glenmark Pharmaceuticals s.r.o Fibichova 143,566 17 Vysoké Mýto, Czech Republic Glenmark Pharmaceuticals Europe Limited Building 2, Croxley Green Business Park, Croxley Green, Hertfordshire, WD18 8YA, United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following names:
France Germany:
Trospipharm 20mg comprimé pelliculé Trospiumchlorid Glenmark 20mg Filmtabletten
United Kingdom
Trospium chloride 20mg film-coated tablets
This leaflet was last revised in 03/2018.
Frequently asked questions about Trospium chloride 20mg film-coated tablets
How do I take Trospium chloride 20mg film-coated tablets?
Trospium chloride 20mg film-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.
What is the active substance in Trospium chloride 20mg film-coated tablets?
The active substance in Trospium chloride 20mg film-coated tablets is trospium chloride.
Are there equivalent medicines to Trospium chloride 20mg film-coated tablets?
Medicines with the same active substance, strength and form include: Regurin 20 mg Coated Tablets. 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 Trospium chloride 20mg 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.
Can I get Trospium chloride 20mg film-coated 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: trospium chloride
- 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 (e.g. idiopathic or neurologic detrusor overactivity).
4.2. Posology and method of administration
Posology
One film-coated tablet twice daily (equivalent to 40 mg of trospium chloride per day).
The need for continued treatment should be reassessed at regular intervals of 3-6 months.
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 film-coated tablet per day or every second day (equivalent to 20 mg of trospium chloride per day or every second day).
Paediatric population
The safety and efficacy of Trospium chloride 20mg film-coated tablets in children under 12 years of age has not been established. No data are available.
Method of administration
The film-coated tablet should be swallowed whole with a glass of water before meals on an empty stomach.
4.3. Contraindications
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 trospium chloride or any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
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.
Hepatic impairment
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.
Renal impairment
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 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.
Trospium chloride 20mg film-coated tablets contain lactose monohydrate and sucrose.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Patients with rare hereditary problems of fructose intolerance or sucrose-isomaltase insufficiency should not take this medicine.
4.5. Interaction with other medicinal products and other forms of interaction
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 medicinal products may be altered.
Pharmacokinetic interactions:
An inhibition of the absorption of trospium chloride with drugs like guar, cholestyramine 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 active substance 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 pharmakinetics of digoxin, an interaction with other active substances eliminated by active tubular secretion cannot be excluded.
4.6. Fertility, pregnancy and lactation
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 Trospium chloride 20mg film-coated tablets, no clinical data on exposed pregnancies are available.
Caution should be exercised when prescribing to pregnant or breastfeeding women.
4.7. Effects on ability to drive and use machines
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.
4.8. Undesirable effects
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 trospium chloride 20 mg film-coated tablets:
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)
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 national reporting system Yellow Card Scheme www.mhra.gov.uk/yellowcard.
4.9. Overdose
After 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 overdose 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 about this leaflet
Ask anything about Trospium chloride 20mg 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.