Consumer Medicine Information
What is in this leaflet?
The leaflet answers some common questions about PRO-BANTHINE tablets.
It does not contain all the available information about PRO-BANTHINE.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking PRO-BANTHINE against the benefits he or she expects it will have.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What is PRO-BANTHINE?
The name of your medicine is PRO-BANTHINE.
The active ingredient is called propantheline bromide.
Propantheline bromide belongs to a group of medicines called the anticholinergics.
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 available as a 15 mg tablet.
How does PRO-BANTHINE work
PRO-BANTHINE works by stopping some of the actions of a naturally occurring substance called acetylcholine which then reduces:
the amount of acid produced by your stomach
cramps or spasms in the muscles of your stomach, intestine and urinary tract
the amount of sweat produced by your body
What is PRO-BANTHINE used for
PRO-BANTHINE is used to treat a number of different conditions:
ulcers in the stomach (gastric ulcers) and in the first part of the intestine (duodenal ulcers) with the assistance of other medicines
urinary problems caused by nerves or muscles that control the bladder
Use PRO-BANTHINE only as directed and consult a health care professional if pain or symptoms persist. Your doctor may have prescribed PRO-BANTHINE for another condition.
Ask your doctor if you have any questions about why PRO-BANTHINE has been prescribed for you.
If you have any concerns, you should discuss this with your doctor.
PRO-BANTHINE tablets are only available with a doctor's prescription.
PRO-BANTHINE is not recommended for use in children.
Before you take PRO-BANTHINE
When you must not take it
Do not take PRO-BANTHINE if you are allergic to:
propantheline bromide or any other anticholinergic agent
any of the ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction to PRO-BANTHINE may include red, itchy skin rashes, difficulty in breathing, swelling of the face or throat or faintness.
Do not take PRO-BANTHINE if you have any of the following medical conditions:
Glaucoma, high pressure in the eye
Thyrotoxicosis, a condition of excessive thyroid hormones
obstructive gastrointestinal problems
intestinal problems, including colitis
obstructive urinary tract problems
hiatus hernia (belching and heart burn)
Do not use PRO-BANTHINE after the expiry date (EXP.) printed on the pack. If you take it after the expiry date has passed, it may have no effect at all, or worse, there may be an entirely unexpected effect.
Do not take PRO-BANTHINE if the packaging is torn, shows signs of tampering or visible signs of deterioration. If it has expired or is damaged, return it to your pharmacist for disposal.
Before you start to take it
You must tell your doctor if:
1. you are allergic to any other medicines or any foods, dyes or preservatives.
2. 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.
3. you are breast-feeding or intend to breastfeed.
Special care is recommended if you are breast-feeding, 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.
Elderly patients are more likely to have less effective kidney or liver function due to age. This may increase the risk of side effects. You should discuss how much PRO-BANTHINE to take with your doctor or pharmacist.
4. You have any other medical conditions/ health problems, including:
fever or exposure to high environmental temperatures
an overactive thyroid gland
high blood pressure
liver and/or kidney disease
problems with the nervous system
If you have not told your doctor about any of the above, tell them before you start to take any PRO-BANTHINE.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
SOME medicines may interact with PRO-BANTHINE.
antacids and anti-diarrhoeals
digoxin, a medicine used to treat heart failure
medicine used for stomach cramps or spasms
painkillers e.g. pethidine
anti-parkinson drugs e.g. levodopa
medicines used to treat irregular heart beats e.g. disopyramide, procainamide or quinidine
antihistamines, medicines used to prevent or relieve symptoms of allergy
antidepressants, medicines used to treat depression
metoclopramide, medicine used to treat nausea
ketoconazole, medicine used to treat fungal infections
cisapride, medicine that stimulates stomach muscle contraction
medicines used to treat the condition myasthenia gravis
medicines used to treat certain mental and emotional conditions
corticosteroids, e.g. prednisolone, cortisone
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.
In the future, before you start to take any other medicine, tell your doctor or pharmacist that you are taking PRO-BANTHINE.
How to take PRO-BANTHINE
Follow your doctor's instructions carefully, as they may differ from the information contained in this leaflet.
If you do not understand the instructions on the bottle, ask your doctor or pharmacist for help.
a.) How much to take
The recommended doses of PRO-BANTHINE are:
For treatment of peptic ulcers
Adults: 1 tablet three times daily and 2 tablets at bedtime.
For treatment of other conditions
Adults: 1 to 2 tablets four times daily.
The safety and efficacy of PRO-BANTHINE in children has not been established.
Different people respond differently to PRO-BANTHINE, so your doctor may tell you to take a different dose.
Do not change your dose of PRO-BANTHINE unless your doctor tells you to do so.
Do NOT take more than 8 tablets in one day.
b.) How to take it
PRO-BANTHINE tablets should be swallowed with a glass of water.
c.) When to take it
Take your PRO-BANTHINE tablets 30 minutes before a meal.
d.) How long to take it
Continue taking PRO-BANTHINE as long as your doctor recommends it.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take your dose as soon as you remember, and then go back to taking it as you would normally.
Do not take a double dose to make up for the dose that you missed.
If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.
Do not try to make up for missed doses by taking more than one dose at a time. This may increase the chance of you getting an unwanted side effect.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you take too much (Overdose):
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to casualty at your nearest hospital, if you think that you or anyone else may have taken too much PRO-BANTHINE. 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 behaviour such as restlessness and excitement; flushing of the skin; a fall in blood pressure; breathing difficulties; and paralysis.
While you are using PRO-BANTHINE
Things you must do
Immediately stop taking PRO-BANTHINE if a skin rash or other allergic reaction occurs.
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 you 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 must not do
Do not take any other medicines while you are taking PRO-BANTHINE without first telling your doctor.
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. PRO-BANTHINE can also affect your eyesight by blurring your vision.
Do not give this medicine to anyone else, even if his or her symptoms seem similar to 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.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking PRO-BANTHINE. PRO-BANTHINE helps most people with the medical conditions listed in the beginning of this leaflet, but it may have unwanted side effects in some people.
All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist any questions you may have.
Tell you doctor if you notice any of the following and they worry you:
difficulty in swallowing and talking
inability to sleep
loss of sense of taste
reduction in the amount of breast milk
These side effects are usually mild.
Tell your doctor or pharmacist immediately if you notice any of the following:
pinkish, itchy swellings on the skin, also called hives or nettle rash
unable to pass urine
difficulty passing urine
fast, pounding or irregular heart beats
These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.
If any of the following happen, tell your doctor or pharmacist immediately or go to casualty at your nearest hospital:
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
This is a very serious side effect. You may need urgent medical attention or hospitalisation. This side effect is very rare.
Some people may get other side effects with PRO-BANTHINE.
Check with your doctor as soon as possible if you have any problems while taking PRO-BANTHINE, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
After using PRO-BANTHINE
Keep your tablets in the bottle they were provided in until it is time to take them.
Keep it where children cannot reach it.
A locked cupboard at least one and a half metres above the floor is a good place to store medicines.
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.
Do not leave it in the car or on windowsills. Heat and dampness can destroy some medicines.
Do not take PRO-BANTHINE if the tablets do not look quite right.
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 left over.
What it looks like
PRO-BANTHINE 15 mg tablets are pink, sugar-coated tablets in bottles of 100 and 500.
Each PRO-BANTHINE tablet contains 15 mg of propantheline bromide as the active ingredient.
The other ingredients in each tablet are:
iron oxide yellow CI77492
iron oxide red CI77491
PRO-BANTHINE tablets contain lactose and sucrose, but do NOT contain any gluten.
Sponsor or Supplier
Sigma Pharmaceuticals Pty Ltd
(A.C.N. 004 118 594)
1408 Centre Road
Clayton, Victoria, 3168
Telephone: 03 - 9839 2800
The Australian Registration Number for PRO-BANTHINE 15 mg tablets is AUST R 10256.
This leaflet was prepared in February 2001.