PRO-BANTHINE Tablet Ref.[27547] Active ingredients: Propantheline

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’.

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.

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.

Pro-Banthine may produce drowsiness or blurred vision. Patients should not drive or operate machinery if affected in this way.

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.

None reported.