Pro-Banthine Tablets 15mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pro-Banthine tablets 15mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Propantheline Bromide 15mg
3 PHARMACEUTICAL FORM
Tablets
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Adjunctive in GI disorders characterised by smooth muscle spasm.
Hyperhidrosis
Adult enuresis
4.2 Posology and method of administration
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).
Children
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.
Route of administration Oral
4.3 Contraindications
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, prostatic enlargement and in patients who are hypersensitive to propantheline bromide.
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.
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.
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 nondepolarising 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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pro-Banthine inhibits parasympathetic activity by blocking the action of the neurohormone, acetylcholine, on the neuroeffector cell. This blocking action of Pro-Banthine is instrumental in reducing gastric acid secretion and gastrointestinal motor activity.
5.2 Pharmacokinetic properties
Propantheline bromide is extensively metabolised in man. Some enzymatic hydrolysis of the drug may occur in the gastrointestinal tract prior to its absorption.
Studies in healthy men demonstrated that peak plasma levels of unchanged drug were reached within 2 hours of a single, oral dose of propantheline bromide. Following single oral dosing the plasma elimination half-life was about 2 to 3 hours and some 1% to 10% of propantheline bromide was excreted in urine as unchanged drug.
In healthy men studies have shown onset of antimuscarinic effects within 1 hour of oral administration. Effects persisted for up to 6 hours after oral dosing.
5.3 Preclinical safety data
Not applicable
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
In the tablet core: lactose, corn starch, talc, light liquid paraffin and magnesium stearate.
In the coating: sucrose, magnesium carbonate, castor oil, cosmetic red oxide (E172), cosmetic ochre no. 1624 (E172), calcium carbonate, saccharin sodium, titanium dioxide (E171), talc, purified water and carnauba wax.
6.2 Incompatibilities
None reported
6.3 Shelf life
18 months
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Foil/PVC-PVdC strips of 100 or 112 tablets.
HDPE bottles of the appropriate size to accommodate 1000 or 5000 tablets
Special precautions for disposal
6.6
No special instructions.
7 MARKETING AUTHORISATION HOLDER
Archimedes Pharma UK Limited
Galabank Business Park
Galashiels
TD11QH
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 12406/0026
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
28 February 1998
10 DATE OF REVISION OF THE TEXT
30/06/2015