Consumer medicine information

Pro-Banthine Tablet

Propantheline bromide

BRAND INFORMATION

Brand name

Pro-Banthine

Active ingredient

Propantheline bromide

Schedule

SUMMARY CMI

PRO-BANTHINE TABLET

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using PRO-BANTHINE?

PRO-BANTHINE contains the active ingredient propantheline bromide. PRO-BANTHINE is used to treat number of conditions like gastric ulcers, duodenal ulcers, urinary problems caused by nerves or muscles that control bladder, excessive sweating,

For more information, see Section 1. Why am I using PRO-BANTHINE? in the full CMI.

2. What should I know before I use PRO-BANTHINE?

Do not use it if you have ever had an allergic reaction to PRO-BANTHINE or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use PRO-BANTHINE? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with PRO-BANTHINE and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use PRO-BANTHINE?

PRO-BANTHINE tablet should be swallowed with a glass of water.
Take your PRO-BANTHINE tablets 30 minutes before a meal.

More instructions can be found in Section 4. How do I use PRO-BANTHINE? in the full CMI.

5. What should I know while using PRO-BANTHINE?

Things you should do	Remind any doctor, dentist, or pharmacist you visit that you are using PRO-BANTHINE. Use PRO-BANTHINE exactly as directed or as your doctor has prescribed.
Things you should not do	Do not take any other medicines while you are taking PRO-BANTHINE without first telling your doctor. Do not give this medicine to anyone else, even if his or her symptoms seem similar to yours.
Driving or using machines	Do not drive, operate machinery, or participate in dangerous activities where alertness is required, until you know how PRO-BANTHINE affects you. PRO-BANTHINE may cause drowsiness or dizziness in some people and therefore may affect alertness.
Drinking alcohol	Tell your doctor if you drink alcohol. Alcohol may interfere with PRO-BANTHINE
Looking after your medicine	Keep PRO-BANTHINE in a cool dry place where the temperature stays below 30°C and protect from light Do not store it, or any other medicines in a bathroom or near a sink.

For more information, see Section 5. What should I know while using PRO-BANTHINE? in the full CMI.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects like thirstiness, dry mouth, dry skin, difficulty n swallowing and talking, nervousness, drowsiness, dizziness, weakness, confusion, headache, blurred vision, nausea, vomiting, bloatedness, constipation, flushing, inability to sleep, decreased sweating, loss of sense of taste, impotence, reduction in the amount of breast milk tell your doctor immediately.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

PRO-BANTHINE TABLET

Active ingredient(s): propantheline bromide

Consumer Medicine Information (CMI)

This leaflet provides important information about using PRO-BANTHINE. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using PRO-Banthine.

Where to find information in this leaflet:

1. Why am I using PRO-BANTHINE?
2. What should I know before I use PRO-BANTHINE?
3. What if I am taking other medicines?
4. How do I use PRO-BANTHINE?
5. What should I know while using PRO-BANTHINE?
6. Are there any side effects?
7. Product details

1. Why am I using PRO-BANTHINE?

PRO-BANTHINE contains the active ingredient propantheline bromide. PRO-BANTHINE belongs to group of medicines called the anti-cholinergic.

Anticholinergics are used to reduce both gastric acid and other secretions in the stomach, and to reduce cramps or spasms in the muscles of your stomach, intestine, and urinary tract.

PRO-BANTHINE is used to treat a number of different conditions:

It reduces:

ulcers in the stomach (gastric ulcers) and in the first part of intestine (duodenal ulcers) with the assistance of other medicines
urinary problems caused by nerves or muscles that control the bladder.
excessive sweating

2. What should I know before I use PRO-BANTHINE?

Warnings

Do not use PRO-BANTHINE if:

you are allergic to propantheline bromide or any other anticholinergic agent, or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
Some of the symptoms of an allergic reaction to PRO-BANTHINE may include red, itchy, skin rashes.

Check with your doctor if you:

have any other medical conditions:
Glaucoma, high pressure in the eye
Thyrotoxicosis, a condition of excessive thyroid hormones
Obstructive gastrointestinal problems
Prostate problems
Intestinal problems, including colitis.
Myasthenia gravis
Obstructive urinary tract problems
Hiatus hernia (belching and heart burn)
Acute bleeding
take any medicine for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

PRO-BANTHINE is rated in Australia as a Category B2 drug for the use in pregnancy.

Your doctor will discuss the risks and benefits of taking PRO-BANTHINE during pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Special care is recommended if you if you are breastfeeding, as no studies have been conducted in breast feeding mothers. Your doctor will discuss the risks and benefits of taking PRO-BANTHINE during breast feeding.

Before you start to take it

You are allergic to any other medicines or any foods, dyes or preservatives.
Any other medical conditions/health problems, including:
Stomach and intestinal problems, including colon inflammation, small bowel not working properly
Heart diseases
Lung problems
Fever or exposure to high environmental temperatures
Bleeding disorders
An overactive thyroid gland
High blood pressure
Liver and/or kidney disease
Problems with nervous system
Downs syndrome
Hereditary intolerances such as galactose, lactose, fructose, glucose, sucrase-isomaltase

Elderly patients are more likely to have less effective kidney or liver function due to age. This may increase the risk of side effects.

If you have not told your doctor about any of the above, tell them before you start to take any PRO-BANTHINE.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with PRO-BANTHINE and affect how it works. These include:

Antacids and anti-diarrhoeals
Digoxin, a medicine used to treat heart failures
Medicine used for stomach, cramps or spasms
Painkillers e.g., pethidine, nefopam, and paracetamol
Anti-parkinson drugs e.g.,levodopa
Anti-arrhythmics
medicines used to treat irregular heart beats e.g, disopyramide, procainamide or quindine
antihistamines, medicines used to prevent or relive symptoms of allergy
anti-depressants, medicines used to treat depression
metoclopramide and domperidone, medicines used to treat nausea
ketoconazole, medicine used to treat fungal infections
potassium chloride
cisapride, medicine that stimulates stomach muscle contraction
medicine used to treat certain mental and emotional conditions corticosteroids e.g., prednisolone, cortisone.
other anticholinergics
mematine, medicine used to treat Alzheimer's
nitrates
other anti-infectives

The above medicines may either reduce the effectiveness of PRO-BANTHINE, reduce its own effectiveness and/or react with PRO-BANTHINE resulting in untoward or sometimes dangerous side effects. This list is not exhaustive. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking PRO-BANTHINE.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect PRO-BANTHINE.

4. How do I use PRO-BANTHINE?

How much to take / use

Follow your doctor's instructions carefully, as they may differ from the information contained in this leaflet.
Follow the instructions provided and use PRO-BANTHINE until your doctor tells you to stop.
If you do not understand the instructions on the bottle, ask your doctor or pharmacist for help.

When to take / use PRO-BANTHINE

PRO-BANTHINE tablets should be consumed 30 minutes before a meal.

If you forget to use PRO-BANTHINE

PRO-BANTHINE should be used regularly at the same time each day. If you miss your dose at the usual time, take your dose as soon as you remember, and then go back to taking it as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.

Do not take a double dose to make up for the dose you missed.

This may increase the chance of you getting an unwanted side effect.

If you have trouble remembering when to take your medicines, ask your pharmacist for some hints.

If you use too much PRO-BANTHINE

If you think that you have used too much PRO-BANTHINE, you may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

Also report any other medicine or alcohol which has been taken. You may need urgent medical attention.

Keep telephone numbers for these places handy.

If you take too much PRO-BANTHINE you may have the following symptoms: Increased severity of the side effects listed; changes in behavior such as restlessness and excitement; flushing of the skin; a fall in blood pressure; breathing difficulties; and paralysis.

5. What should I know while using PRO-BANTHINE?

Things you should do

Call your doctor straight away if you:

Develop a skin rash or other allergic reaction occurs.
If you feel PRO-BANTHINE is not helping your condition.

Remind any doctor, dentist, or pharmacist you visit that you are using PRO-BANTHINE.

Use PRO-BANTHINE exactly as directed or as your doctor has prescribed.

Tell any other doctors, dentists or pharmacists who are treating you that you are taking PRO-BANTHINE

Tell your doctor if you become pregnant while taking PRO-BANTHINE

Tell your doctor if you feel PRO-BANTHINE is not helping your condition.

Visit your doctor regularly.

Your doctor needs to check your progress and see whether you need to stop taking PRO-BANTHINE.

Always discuss with your doctor any problems or difficulties during or after taking PRO-BANTHINE.

Things you should not do

Do not take any other medicines while you are taking PRO-BANTHINE without first telling your doctor.
Do not give this medicine to anyone else, even if his or her symptoms seem like yours

Things you must be careful of

Be careful when exercising or when the weather is hot.

Make sure you keep cool in hot weather and keep warm in cool weather.

PRO-BANTHINE may affect the way your body reacts to temperature changes. It may prevent sweating, even during heatwaves. Hot baths or saunas may make you feel dizzy or faint while you are taking this medicine.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how PRO-BANTHINE affects you.

PRO-BANTHINE may cause drowsiness or dizziness in some people and therefore may affect alertness. PRO-BANTHINE can also effect your eyesight by blurring your vision.

Drinking alcohol

Tell your doctor if you drink alcohol.

Alcohol may interfere with PRO-BANTHINE.

Looking after your medicine

Keep your tablets in the bottle they were provided in until it is time to take them.
Keep PRO-BANTHINE in a cool dry place where the temperature stays below 30°C and protect from light.
Heat and dampness can destroy some medicines.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat, or sunlight; for example, do not store it:

in the bathroom or near a sink, or
in the car or on windowsills.

Keep it where young children cannot reach it.

A locked cupboard at least one and a half meters above the floor is a good place to store medicines.

Do not take PRO-BANTHINE if the tablets do not look quite right.

When to discard your medicine (as relevant)

If your doctor tells you to stop taking this medication OR it has passed its expiry date, ask your pharmacist what to do with any leftover medication.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
Thirstiness Dry mouth Dry skin Difficulty in swallowing and talking Nervousness Drowsiness Dizziness Weakness Confusion Headache Blurred vision Nausea Vomiting Bloatedness Constipation Flushing Inability to sleep Decreased sweating Loss of sense of taste Impotence Reduction in the amount of breast milk	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects	What to do
Skin rash Pinkish, itchy swelling on the skin, also called hives or nettles rash Unable to pass urine Difficulty passing urine Fever Fast, pounding or irregular heart beats	Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Very Serious side effects

Very Serious side effects	What to do
Sudden signs of allergy such as rash, itching or hives on the skin swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing.	Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What PRO-BANTHINE contains

Active ingredient (main ingredient)	Propantheline bromide
Other ingredients (inactive ingredients)	Lactose Starch maize Magnesium stearate Talc-purified Opadry II complete film coating system 85G63218 Orange
Potential allergens	Soya bean and sugars as lactose, but does NOT contain any gluten

Do not take this medicine if you are allergic to any of these ingredients.

What PRO-BANTHINE looks like

PRO-BANTHINE 15mg tablets are pale orange film coated tablets in bottles of 100. (Aust R 207283).

Who distributes PRO-BANTHINE

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121
Australia

This leaflet was prepared in November 2023.

Published by MIMS January 2024

BRAND INFORMATION

Brand name

Pro-Banthine

Active ingredient

Propantheline bromide

Schedule

1 Name of Medicine

Propantheline bromide.

2 Qualitative and Quantitative Composition

Pro-Banthine film-coated tablets contain 15 mg of propantheline bromide.

Excipients with known effect.

Contains soya bean and sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Pro-Banthine 15 mg, pale orange film-coated tablets.

4 Clinical Particulars

4.1 Therapeutic Indications

Pro-Banthine is indicated as an adjunctive therapy in the treatment of peptic ulcer (gastric and duodenal). Pro-Banthine is also indicated for the neurogenic bladder, urinary incontinence in patients with detrusor hyperactivity, and hyperhidrosis.

4.2 Dose and Method of Administration

Adults.

In peptic ulcer cases, one tablet three times a day, 30 minutes before each meal, and two at bedtime is usual (75 mg daily). There is considerable variation of individual needs and the dosage may be raised until dryness of the mouth occurs. A dose slightly lower than this amount is optimal. The maximum daily dosage should not exceed 120 mg.

For other indications.

The dose is one or two tablets (15 mg to 30 mg) four times daily.

4.3 Contraindications

Propantheline bromide is contraindicated in the following conditions:
Hypersensitivity to propantheline bromide or other anticholinergic drugs, or any of the ingredients in Pro-Banthine tablets (see Section 6.1 List of Excipients).
Tachycardia secondary to cardiac insufficiency or thyrotoxicosis.
Glaucoma, since mydriasis is to be avoided.
Obstructive disease of the gastrointestinal tract (pyloroduodenal stenosis, achalasia, paralytic ileus, etc.).
Obstructive uropathy (prostatism).
Intestinal atony of elderly or debilitated patients.
Toxic megacolon complicating ulcerative colitis.
Hiatal hernia associated with reflux oesophagitis.
Unstable cardiovascular adjustment in acute haemorrhage.
Myasthenia gravis.
Prostatic enlargement.

4.4 Special Warnings and Precautions for Use

Potential risks or benefits should be carefully considered before using the product.
Propantheline bromide should be used with caution in patients with severe cardiac disease in whom even a slight increase in heart rate is undesirable.
Propantheline bromide should be used with caution in the elderly and in all patients with autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, mitral stenosis or hypertension.
Propantheline bromide should be used with caution in patients with chronic lung disease, as inspissation and formation of bronchial plugs may occur, due to the reduction in bronchial secretion.
In some patients, especially those with ileostomy or colostomy, diarrhoea may be a symptom of incomplete intestinal obstruction. Propantheline bromide therapy should be avoided in such patients.
Caution is also required in patients with known or suspected gastrointestinal infections such as Clostridium difficile-associated diarrhoea and colitis, gastrointestinal reflux disease, acute myocardial infarction, cardiac insufficiency and pyrexia. Gastrointestinal motility may decrease, so continuance of causative toxins and organisms occur, therefore prolonging the infection symptoms.
Caution is required in patients with ulcerative colitis, since in these patients propantheline bromide may suppress intestinal motility to the point of producing paralytic ileus, thus precipitating or aggravating toxic megacolon.
Caution is required for those patients with fever or who may be exposed to elevated environmental temperatures, as there may be an increase in the risk of hyperthermia occurring. Fever and possibly heat stroke may occur due to anhidrosis.
Pro-Banthine should be used with caution in patients with Down's syndrome.
Patients with rare hereditary problems of galactose intolerance or total lactase deficiency should not take this medicine.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Use in the elderly.

Caution should also be exercised in elderly patients because of the possibility of inducing urinary retention. Urinary retention may be avoided if these patients are advised to micturate at the time of taking medication. Caution should also be exercised in elderly patients due to the danger of precipitating undiagnosed glaucoma.

Paediatric use.

Safety and efficacy of propantheline bromide in children have not been established.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Antacids or absorbent antidiarrheals.

May reduce the absorption of propantheline bromide, therefore resulting in a reduction of its therapeutic effectiveness. Therefore, take two to three hours apart from doses of propantheline bromide.

Anticholinergics.

May delay absorption of other medication given concomitantly.

Antimyasthenics.

Concurrently used with propantheline bromide may further reduce intestinal motility.
Increased intraocular pressure may result from concurrent administration of anticholinergics and corticosteroids.

Cisapride.

Concurrent use of propantheline bromide with cisapride is likely to counteract gastrointestinal motility normally induced by cisapride.

Digoxin.

Tablets concurrently used with propantheline bromide may assist absorption and lead to elevated serum digoxin levels.

Haloperidol.

Concurrently used with propantheline bromide may decrease the effectiveness of haloperidol as an antipsychotic agent, increased risk of antimuscarinic side effects when antimuscarinics are given with clozapine.

Ketoconazole.

Anticholinergics may decrease gastric acid output and/or increase gastrointestinal pH, possibly resulting in reduction of ketoconazole absorption during concurrent use with anticholinergics. Therefore, take propantheline bromide at least two hours after ketoconazole.

Levodopa.

Concurrent administration of anticholinergics and levodopa may decrease the extent of absorption of levodopa in the small intestine by causing increased metabolism of levodopa in the stomach. If propantheline bromide is discontinued without a concomitant reduction in levodopa dosage, toxicity may result from the increased absorption of levodopa. Increased risk of antimuscarinic side effects when antimuscarinics are given with amantadine.

Metoclopramide.

Concurrently used with propantheline bromide may cause propantheline bromide to antagonise the gastrointestinal motility effects of metoclopramide.

Opioid (narcotic) analgesics.

Concurrently used with propantheline bromide may cause an increase in the risk of severe constipation. This may lead to urinary retention or paralytic ileus occurring.

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.
Propantheline bromide may also potentiate the sedative effect of phenothiazines.

Potassium chloride, especially wax-matrix preparations.

Concurrent use with propantheline bromide may increase severity of potassium chloride-induced gastrointestinal lesions.

Urinary alkalisers (e.g. antacids, carbonic anhydrase inhibitors and sodium bicarbonate).

May cause a delay in urinary excretion, therefore potentiating propantheline bromide's therapeutic and/or side effects.

Memantine.

Effects of antimuscarinics possibly enhanced by memantine.

Nitrates.

Antimuscarinics possibly reduce effects of sublingual tablets of nitrates (failure to dissolve under tongue owing to dry mouth).

Domperidone.

Antimuscarinics antagonise effects of domperidone on gastrointestinal activity.

Anti-infectives.

The absorption of nitrofurantoin has been reported to be enhanced.

Parasympathomimetics.

Antimuscarinics antagonise effects of parasympathomimetics.
Excessive cholinergic blockage may occur if propantheline bromide is given concomitantly with antihistamines; Type I antiarrhythmic drugs (e.g. disopyramide, procainamide or quinidine); synthetic and semisynthetic anticholinergic agents; belladonna alkaloids; narcotic analgesics e.g. pethidine; phenothiazines, tricyclic antidepressants, MAOIs or tricyclics, synthetic and semi-synthetic antimuscarinic agents or other psychoactive drugs.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
The safe use of propantheline bromide in pregnancy has not been established. Therefore, the use of this drug in women of childbearing potential requires that the benefits be weighed against its possible hazards to mother and foetus.
Australian categorisation definition of Category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of foetal damage.
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.
Information regarding the secretion of propantheline bromide in breast milk is limited to uncontrolled data derived from marketing experience. Such experience does not suggest that significant quantities of propantheline bromide are secreted in breast milk, since propantheline bromide is incompletely absorbed from the gastrointestinal tract and has poor lipid solubility. Because many drugs are excreted in human milk, caution should be exercised when propantheline bromide is administered to a breastfeeding woman. Suppression of lactation may occur with anticholinergic drugs.

4.7 Effects on Ability to Drive and Use Machines

Propantheline bromide may produce drowsiness or blurred vision. Patients should be cautioned regarding operating machinery or motor vehicles during treatment with this drug.

4.8 Adverse Effects (Undesirable Effects)

The adverse effects of propantheline bromide are usually dose related and are usually reversible when the therapy is discontinued.
The following adverse effects have been reported:

Cardiovascular.

Palpitations, arrhythmias, bradycardia followed by tachycardia.

Neurological.

Insomnia, drowsiness, dizziness, nervousness, headache, mental confusion, weakness.

Dermatological and hypersensitivity reactions.

Anaphylaxis, urticaria, rashes, allergic dermatitis.

Gastrointestinal.

Bloatedness, nausea, vomiting, constipation.

Genitourinary.

Urinary hesitancy and retention, impotence.

Respiratory.

Reduced bronchial secretions.

Ophthalmic.

Blurred vision, mydriasis, cycloplegia, increased ocular tension, dilation of the pupils with loss of accommodation and sensitivity to light.

Other effects.

Xerostomia (dry mouth), decreased salivary secretions, decreased sweating (anhidrosis), heat stroke, flushing, dryness of the skin, dryness of the mouth, thirst, difficulty in swallowing and talking, loss of the sense of taste, suppression of lactation.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

4.9 Overdose

Symptoms.

The symptoms of overdosage with propantheline bromide progress from an intensification of the usual side effects (from nausea and vomiting) to CNS disturbances (from restlessness and excitement to psychotic behaviour), hyperthermia, circulatory changes, (flushing, fall in blood pressure, circulatory failure), respiratory failure, paralysis and coma. With overdosage, a curare-like action may occur i.e. neuromuscular blockade leading to muscular weakness and possible paralysis. Additionally, a rash may appear on the face or the upper trunk of the body. At high doses, propantheline bromide has some ganglion blocking activity therefore postural hypotension and impotence may occur.

Treatment.

Treatment of overdosage of propantheline bromide consists of symptomatic and supportive therapy. An aqueous slurry of activated charcoal may be administered to decrease drug adsorption. For the reversal of severe overdosage symptoms, an intravenous injection of physostigmine 0.5 to 2 mg is administered, and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically (alcohol sponging, ice packs).
Excitement of a degree which demands attention may be managed with sodium thiopentone 2% solution given slowly intravenously or diazepam, 5 to 10 mg intravenously or 10 mg intramuscularly. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns. Adequate hydration is also required.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Propantheline bromide is an anticholinergic agent which inhibits neural impulses at the effector sites of the parasympathetic nervous system and at the ganglia of the sympathetic and parasympathetic nervous system with peripheral effects similar to atropine. Propantheline bromide does not readily cross the blood-brain barrier thus avoiding the central effects seen with atropine. Propantheline bromide reduces gastric acid secretion and inhibits gastrointestinal motility and has spasmolytic properties. Other secretions including pancreatic juice, sweat and saliva are reduced.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Single oral doses of 15, 30, 45, 60, 75, 90 mg of propantheline bromide tablets were administered to each of 6 subjects and were rapidly absorbed. The absorption half-life of propantheline bromide was 8-30 minutes, and half-life of elimination between 1.3 and 2.1 hours.
After a single 15 mg oral dose of carbon-14 labelled drug given to a healthy man, 390 nanogram/mL peak plasma concentration of total-¹⁴C material is attained at 6 hours.

Distribution.

The distribution of propantheline bromide in the body has not been determined. It appears that it does not readily penetrate the CNS and eye, due to complete ionisation and poor lipid solubility.

Metabolism.

After oral administration to man, propantheline bromide is extensively metabolised primarily by hydrolysis to the inactive materials xanthene-9-carboxylic acid and (2-hydroxyethyl)-diisopropylmethylammonium bromide, approximately half of which occurs in the gastrointestinal tract prior to its absorption. Food appears to substantially decrease the extent of absorption following oral administration.
Average peak plasma concentrations of propantheline bromide after the 15, 30, 45, 60, 75 and 90 mg doses were 6, 29, 81, 62, 148 and 146 nanogram/mL respectively, and were attained within 3 hours of oral dosing. Similarly the average amount of unmetabolised propantheline bromide excreted in the urine was 0.70, 1.08, 1.59, 1.85, 2.42 and 3.06 mg respectively.

Excretion.

Unmetabolised drug represents only a small proportion of the total-¹⁴C materials. The plasma half-life of the total-¹⁴C material is about 9 hours and approximately 70 percent of the dose is excreted in the urine, mostly as metabolites. The urinary excretion of the intact propantheline is about 5 percent after oral administration and about 20 percent after intravenous administration.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

Animal studies to determine the carcinogenic or mutagenic potential of propantheline bromide have not been established. There is no information available on the possible effects of propantheline bromide on human fertility.

6 Pharmaceutical Particulars

6.1 List of Excipients

Pro-Banthine tablets contain lactose monohydrate, purified talc, maize starch, magnesium stearate, and Opadry II complete film coating system 85G63218 Orange.
See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Pro-Banthine tablets are supplied in HDPE bottles (with child-resistant closures) containing 100 tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Propantheline bromide is a white or yellowish-white odourless powder with a very bitter taste. It is very soluble in water, alcohol and chloroform, however is insoluble in ether.
Propantheline bromide is a quaternary ammonium compound with a melting point 157° to 162°C. At relative humidities of more than 50% it is hygroscopic and it is deliquescent above about 90%.

Chemical structure.

The chemical name for propantheline bromide is N-methyl-N,N-bis(1-methylethyl)-2-[(9H-xanthen-9-ylcarbonyl)oxy]ethanaminium bromide. Its structural formula is:

C₂₃H₃₀BrNO₃. Molecular weight: 448.40.

CAS number.

CAS No: 50-34-0.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Medicine.

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Consumer medicine information

Pro-Banthine Tablet

Propantheline bromide

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BRAND INFORMATION

Pro-Banthine 15 mg