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.
Pro-Banthine 15mg 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 Propantheline bromide 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
Pro-Banthine tablets contain the active ingredient propantheline bromide which belongs to a group of drugs known as "antispasmodics". They work by relaxing the muscles of the intestines. Pro-Banthine tablets are used to treat disorders in the gastrointestinal tract which involve muscle spasm. They are also for use by adults who have problems holding their urine, which results in wetting (enuresis), and excessive sweating (hyperhidrosis).
2.
What you need to know before you take it
E PRO-BANTHINE TABLETS
Do not take Pro-Banthine tablets if you have: • an allergy to propantheline bromide or any of the other ingredients of Pro-Banthine (see Section 6) • an obstruction in your gut (gastrointestinal tract), or it is inflamed or does not function normally. These may show themselves as abdominal pain, bloating, reflux or fever • a partial or complete blockage of the bowel that leads to constipation or bloating of the stomach (paralytic ileus) • toxic megacolon (a very dilated colon accompanied by bloating and sometimes fever, abdominal pain or shock) • a hiatus hernia (a condition in which a portion of the stomach protrudes upward into the chest, through an opening in the diaphragm) • pyloric stenosis (a narrowing of the outlet from your stomach which delays food passing out of your stomach and may lead to vomiting) • severe ulcerative colitis (ulcers and inflammation in the large bowel), as Pro-Banthine tablets may worsen the condition • any obstruction in your urinary tract • a muscle weakening disease such as myasthenia gravis or weakness of the intestinal muscles • heart problems following severe bleeding • an enlarged prostate gland • an eye disease called closed angle glaucoma.
Warning and Precautions Talk to your doctor or pharmacist or nurse before taking Pro-Banthine if any of the following conditions applies to you: • pregnancy, likely to become pregnant or are breast-feeding • elderly • diarrhoea, especially if you have a colostomy (opening of the colon by surgery) or ileostomy (opening of the small intestine by surgery) • severe heart disease, especially if an increase in heart rate is undesirable, or an irregular heart beat, heart failure, reduced heart function or any other heart problem (coronary heart disease, congestive heart failure, cardiac arrhythmias) • gastrointestinal reflux • a fever • ulcerative colitis (ulcers and inflammation in the large bowel) as taking Pro-Banthine tablets may result in life-threatening complications of other intestinal conditions • autonomic neuropathy (a disease of the nervous system affecting the bladder muscles, the heart, the digestive tract, and the genital organs) • liver or kidney problems • an overactive thyroid gland • high blood pressure Pro-Banthine should be used with caution in elderly patients and patients with Down's syndrome. These tablets may induce fever and heat stroke in patients in hot weather due to decreased sweating. Children These tablets are not recommended for children. Other Medicines and Pro-Banthine tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines In particular, tell your doctor or pharmacist if you are taking any of the following medicines, because Pro-Banthine may interact with them: • nefopam (a pain killer): the risk of side effects may increase if you take Pro-Banthine tablets • paracetamol: its absorption may be reduced by Pro-Banthine tablets • medicines to reduce high blood pressure: Pro-Banthine tablets may increase the risk of side effects • anti-diabetic medicines: your insulin requirement may be reduced if you take Pro-Banthine tablets • antidepressants: Pro-Banthine tablets may increase the risk of side effects • disopyramide (to treat irregular heartbeat): Pro-Banthine tablets may increase the risk of side effects • ketoconazole (to treat fungal infections): Pro-Banthine tablets may reduce its absorption • nitrofurantoin (to treat infections): Pro-Banthine tablets may enhance its absorption • antihistamines: Pro-Banthine tablets may increase the risk of side effects • antimuscarinic drugs such as belladonna alkaloids (to affect the nervous system): ProBanthine tablets may increase the risk of side effects • haloperidol (to treat psychosis): Pro-Banthine tablets may reduce its effects • clozapine or phenothiazines (to treat psychosis): Pro-Banthine tablets may increase the risk of side effects • digoxin (to treat heart failure): taking Pro-Banthine tablets with slow-dissolving digoxin tablets may cause increased digoxin levels in your blood • domperidone (to treat nausea and vomiting): Pro-Banthine tablets may reduce its effects on gastrointestinal activity
• • • • • •
amantadine (to treat Parkinson's disease and some viral infections): Pro-Banthine tablets may increase the risk of side effects levodopa (to treat Parkinson's disease): Pro-Banthine tablets may reduce its absorption memantine (to treat dementia in Alzheimer's disease): the effects of Pro-Banthine tablets may be enhanced by memantine metoclopramide (to treat nausea, vomiting and migraine): Pro-Banthine tablets may reduce its effects on gastrointestinal activity nitrates (to treat angina): Pro-Banthine tablets may reduce the effects of sublingual nitrate tablets (failure to dissolve under the tongue owing to dry mouth) parasympathomimetics (drugs that are used to affect the nervous system e.g. stimulating digestive secretions; slowing the heart; constricting the pupils; dilating blood vessels): ProBanthine tablets may reduce the effects of these drugs.
If you are not sure which medicines you are already taking, please ask your doctor or pharmacist. Pregnancy and breast-feeding Tell your doctor if you are pregnant, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not breast-feed if you are taking Pro-Banthine tablets unless told to by your doctor. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Do not drive or use machinery as Pro-Banthine tablets may make you feel drowsy or cause blurred vision. Pro-Banthine tablets contain lactose and sucrose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product. This medicine contains less than 1 mmol sodium (23 mg) per 15 mg tablet, that is to say essentially 'sodium-free'. 3.
How to take it
PRO-BANTHINE TABLETS
Always take Pro-Banthine tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Tablets should be taken at least one hour before meals as food affects their action. Swallow the tablets whole with some water. The usual starting dose is one tablet before each meal and two tablets at bedtime. Your doctor will then adjust the dose according to your response to the tablets. This may be increased to a maximum of eight tablets a day. Elderly: The dosage is the same as stated for adults, but the elderly should take special care when taking ProBanthine tablets because they are more susceptible to the side effects. Children: Pro-Banthine tablets are not recommended for use in children.
If you take more Pro-Banthine tablets than you should If you accidentally take more tablets than you should, or you suspect that a child has swallowed the tablets, contact your doctor straight away or go to your nearest hospital casualty department immediately. Take this leaflet and the pack of tablets along with you, if you can. Symptoms of excessive overdosage are restlessness, hallucinations, confusion, fits, circulatory failure (signs of circulatory failure include pain or discomfort in the chest, shortness of breath, cold hands or feet, numbness or tingling in hands or feet), slow or shallow breathing, muscle paralysis and coma. If you forget to take Pro-Banthine tablets If you forget to take your tablets, take your next dose as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose. If in doubt about what you should do, please contact your doctor or pharmacist or nurse. If you have any further questions on the use of this product, ask your doctor or pharmacist or nurse.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Pro-Banthine tablets and seek immediate medical attention if you experience any of the following: • Eye pain, severe difficulty focusing your eyes or being very sensitive to light • Severe difficulty urinating and emptying the bladder. Tell your doctor if you experience any of the following: • increase or decrease in your heart rate; palpitations (unpleasant or unusual sensation of your heart beating) or irregular heartbeat • constipation • nausea (feeling sick) and vomiting • dry mouth, feeling thirsty and finding it difficult to swallow • dry skin, feeling hot with reddening of the face and neck but with very little sweating, heatstroke • dryness of the airways (this may make it difficult to cough up phlegm) • confusion in the elderly • dizziness. If you are elderly, you may be particularly sensitive to the side effects of Pro-Banthine tablets. Tell your doctor immediately if you experience any of the side effects listed above. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at 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.
5.
How to store it
PRO-BANTHINE TABLETS
Keep out of the sight and reach of children. Do not store above 25°C. Store in the original container in order to protect from light.
Do not use Pro-Banthine tablets after the expiry date which is stated on the carton after 'Expiry:' and on blister after 'Exp:'. The expiry date refers to the last day of that month. 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.
6.
FURTHER INFORMATION
What Pro-Banthine tablets contain The active substance in each tablet is propantheline bromide 15mg. The other ingredients in the tablet are: lactose monohydrate, talc, corn (maize) starch, magnesium stearate and light liquid paraffin. The sugar coating contains: sucrose, calcium carbonate, saccharin sodium, titanium dioxide (E171), magnesium carbonate light, castor oil virgin, talc, ferric oxide red (E172), ferric oxide yellow (E172) and carnauba wax (see also end of Section 2 for lactose and sucrose). What Pro-Banthine tablets look like and contents of the pack Pro-Banthine Tablets are unmarked, pink, sugar-coated tablets. The tablets are supplied in blister packs containing 100 or 112 tablets or in bottles containing 1000 or 5000 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Grünenthal Ltd TOR Building Saint Cloud Way Maidenhead, Berkshire SL6 8BN United Kingdom Manufacturer Haupt Pharma Wülfing GmbH Bethelner Landstrasse 18 31028 Gronau Germany This leaflet was last revised in December 2024
Frequently asked questions about Pro-Banthine 15mg tablets
How do I take Pro-Banthine 15mg tablets?
Pro-Banthine 15mg tablets comes as tablet containing 15mg. 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 Pro-Banthine 15mg tablets?
The active substance in Pro-Banthine 15mg tablets is propantheline bromide.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Pro-Banthine 15mg 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 Pro-Banthine 15mg 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: propantheline bromide
- 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
Pro-Banthine is indicated in adults for the following conditions:
Adjunctive in GI disorders characterised by smooth muscle spasm
Hyperhidrosis
Adult enuresis
4.2. Posology and method of administration
Posology
Adults
The recommended initial starting dose is one tablet before each meal and two tablets at bedtime. Subsequently, dosage should be adjusted according to the patient's individual response and tolerance. Doses up to 120mg may be required in some patients.
Elderly
Elderly patients may be more susceptible to antimuscarinic side effects; glaucoma and urinary retention may occur. Consideration should be given to the presence of other disease and concomitant drug therapy (see contraindications, warnings etc).
Paediatric population
Safety and efficacy of Pro-Banthine in children have not been established.
Caution
Food has been reported to reduce the bioavailability of Pro-Banthine. Tablets should be taken at least one hour before meals.
Method of administration
Oral
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Pro-Banthine is contraindicated in patients with obstructive diseases of the gastrointestinal or urinary tract, pyloric stenosis, paralytic ileus, intestinal atony, severe ulcerative colitis or toxic megacolon, hiatus hernia associated with reflux oesophagitis, unstable cardiovascular adjustment in acute haemorrhage, myasthenia gravis and prostatic enlargement.
Pro-Banthine should not be given to patients with closed-angle glaucoma or those with shallow anterior chamber, since it may raise intra-ocular pressure.
4.4. Special warnings and precautions for use
In some patients, especially those with ileostomy or colostomy, diarrhoea may be a symptom of incomplete intestinal obstruction. Pro-Banthine therapy should be avoided in such patients.
Patients with severe heart disease in whom an increase in heart rate is undesirable should be observed closely if Pro-Banthine is administered.
Patients with ulcerative colitis should be treated with caution, since Pro-Banthine may suppress intestinal motility to the point of producing paralytic ileus, thus precipitating or aggravating toxic megacolon.
Pro-Banthine should be used with caution in the elderly and all patients with autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias or hypertension.
Pro-Banthine may induce fever and heat stroke in patients in a high environmental temperature due to decreased sweating.
Pro-Banthine should be used with caution in patients with Down's syndrome.
Pro-Banthine should also be used with caution in gastrointestinal reflux disease, acute myocardial infarction, cardiac insufficiency and pyrexia.
Patients with rare hereditary problems of fructose intolerance, glucose‑galactose malabsorption or sucrase‑isomaltase insufficiency should not take this medicine.
Patients with rare hereditary problems of galactose intolerance or total lactase deficiency should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per 15 mg tablet, that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
Since antimuscarinics tend to delay gastric emptying they may alter the absorption of other medication given concomitantly.
Analgesics: increased risk of antimuscarinic side effects when antimuscarinics are given with nefopam. The absorption of paracetamol has been reported to be reduced and retarded.
Anti-arrhythmics: increased risk of antimuscarinic side effects with disopyramide.
Antidepressants: increased risk of antimuscarinic side effects when antimuscarinics are given with MAOIs or tricyclics or tricyclic-related antidepressants.
Antifungals: antimuscarinics reduce absorption of ketoconazole.
Antihistamines: increased risk of antimuscarinic side effects when antimuscarinics are given with antihistamines.
Anti-infectives: the absorption of nitrofurantoin has been reported to be enhanced.
Antimuscarinics: excessive muscarinic blockade may occur if Pro-Banthine is given concomitantly with belladonna alkaloids, synthetic and semi-synthetic antimuscarinic agents or other drugs with antimuscarinic activity.
Antipsychotics: antimuscarinics possibly reduce effects of haloperidol; increased risk of antimuscarinic side effects when antimuscarinics are given with clozapine; antimuscarinics reduce plasma concentration of phenothiazines, but risk of antimuscarinic side effects is increased.
Digoxin: concurrent use of Pro-Banthine with slow-dissolving tablets of digoxin may cause increased serum digoxin levels.
Domperidone: antimuscarinics antagonise effects of domperidone on gastrointestinal activity.
Dopaminergics: increased risk of antimuscarinic side effects when antimuscarinics are given with amantadine; antimuscarinics possibly reduce absorption of levodopa.
Memantine: effects of antimuscarinics possibly enhanced by memantine.
Metoclopramide: antimuscarinics antagonise effects of metoclopramide on gastrointestinal activity.
Nitrates: antimuscarinics possibly reduce effects of sublingual tablets of nitrates (failure to dissolve under tongue owing to dry mouth).
Parasympathomimetics; antimuscarinics antagonise effects of parasympathomimetics.
4.6. Pregnancy and lactation
Animal reproduction and teratology studies have not been performed. Cohort data on parasympatholytics indicate a possible association with minor malformations. In view of this, Pro-Banthine should not be administered in pregnancy unless considered essential.
It is unknown whether propantheline bromide is excreted in human breast milk. No animal studies have been conducted. In view of this, Pro-Banthine should not be administered during breast-feeding unless considered essential. Suppression of lactation may occur with parasympatholytics.
4.7. Effects on ability to drive and use machines
Pro-Banthine may produce drowsiness or blurred vision. Patients should not drive or operate machinery if affected in this way.
4.8. Undesirable effects
Side effects of antimuscarinics include dryness of the mouth with difficulty in swallowing and thirst, dilatation of the pupils with loss of accommodation and sensitivity to light, increased intra-ocular pressure, flushing, dryness of the skin, decreased sweating, heat stroke, bradycardia followed by tachycardia, palpitations and arrhythmias, urinary hesitancy and retention, constipation, reduced bronchial secretions, occasional confusion in the elderly, occasional nausea and vomiting, and occasional dizziness.
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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Intensification of the usual side effects may occur. In severe intoxication disturbances of the central nervous system may occur resulting in convulsion, coma, circulatory failure, respiratory depression, delirium, hallucinations and restlessness. Toxic doses of propantheline bromide may produce non-depolarising neuromuscular blocking effects with paralysis of voluntary muscle.
In the event of overdosage, empty the stomach and give activated charcoal. Excitement may be controlled by diazepam. Supportive treatment may require oxygen, assisted ventilation and the administration of fluids. In severe cases (convulsions, hyperpyrexia, respiratory depression) the use of intravenous physostigmine (0.5mg to 2mg) should be considered. Since it has a brief duration of action of about 1 to 2 hours, it may be necessary to repeat injections up to a total dose of 5mg.
💬 Ask about this leaflet
Ask anything about Pro-Banthine 15mg 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.