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PRO-BANTHINE TABLETS 15MG

Active substance(s): PROPANTHELINE BROMIDE

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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 ProBanthine 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 25ºC.

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

6.6

Special precautions for disposal
No special instructions.

7

MARKETING AUTHORISATION HOLDER
Archimedes Pharma UK Limited
Galabank Business Park
Galashiels
TD1 1QH
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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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