Patient Leaflet Updated 30-Nov-2018 | Kyowa Kirin Ltd
PACKAGE LEAFLET: INFORMATION FOR THE USER
PRO-BANTHINE® 15mg TABLETS
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What Pro-Banthine is and what it is used for
2. What you need to know before you take Pro-Banthine tablets
3. How to take Pro-Banthine tablets
4. Possible side effects
5. How to store Pro-Banthine tablets
6. Contents of the pack and other information
1. WHAT PRO-BANTHINE IS AND WHAT IT IS USED FOR
Pro-Banthine tablets contain the active ingredient propantheline bromide which belongs to a group of drugs known as “antispasmodics”. They work by relaxing the muscles of the intestines.
Pro-Banthine tablets are used to treat disorders in the gastrointestinal tract which involve muscle spasm. They are also for use by adults who have problems holding their urine, which results in wetting (enuresis), and excessive sweating (hyperhidrosis).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRO-BANTHINE TABLETS
Do not take Pro-Banthine tablets if you have:
Warning and Precautions
Talk to your doctor or pharmacist before taking Pro-Banthine if any of the following conditions applies to you:
Pro-Banthine should be used with caution in elderly patients and patients with Down’s syndrome.
These tablets may induce fever and heat stroke in patients in hot weather due to decreased sweating.
These tablets are not recommended for children.
Other Medicines and Pro-Banthine tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines
In particular, tell your doctor or pharmacist if you are taking any of the following medicines, because Pro-Banthine may interact with them:
If you are not sure which medicines you are already taking, please ask your doctor or pharmacist.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not breast-feed if you are taking Pro-Banthine tablets unless told to by your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive or use machinery as Pro-Banthine tablets may make you feel drowsy or cause blurred vision.
Pro-Banthine tablets contain lactose and sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.
This medicine contains less than 1 mmol sodium (23 mg) per 15 mg tablet, that is to say essentially ‘sodium-free’.
3. HOW TO TAKE PRO-BANTHINE TABLETS
Always take Pro-Banthine tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Tablets should be taken at least one hour before meals as food affects their action. Swallow the tablets whole with some water.
The usual starting dose is one tablet before each meal and two tablets at bedtime. Your doctor will then adjust the dose according to your response to the tablets. This may be increased to a maximum of eight tablets a day.
The dosage is the same as stated for adults, but the elderly should take special care when taking Pro-Banthine tablets because they are more susceptible to the side effects.
Pro-Banthine tablets are not recommended for use in children.
If you take more Pro-Banthine tablets than you should
If you accidentally take more tablets than you should, or you suspect that a child has swallowed the tablets, contact your doctor straight away or go to your nearest hospital casualty department immediately. Take this leaflet and the pack of tablets along with you, if you can.
Symptoms of excessive overdosage are restlessness, hallucinations, confusion, fits, circulatory failure (signs of circulatory failure include pain or discomfort in the chest, shortness of breath, cold hands or feet, numbness or tingling in hands or feet), slow or shallow breathing, muscle paralysis and coma.
If you forget to take Pro-Banthine tablets
If you forget to take your tablets, take your next dose as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose. If in doubt about what you should do, please contact your doctor or pharmacist.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Pro-Banthine tablets and seek immediate medical attention if you experience any of the following:
Tell your doctor if you experience any of the following:
If you are elderly, you may be particularly sensitive to the side effects of Pro-Banthine tablets. Tell your doctor immediately if you experience any of the side effects listed above.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly 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. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE PRO-BANTHINE TABLETS
Keep out of the sight and reach of children.
Keep the tablets in the original pack to protect from light and store below 25°C.
Do not use Pro-Banthine tablets after the expiry date which is stated on the carton after ‘Expiry:’ and on blister after ‘Exp:’. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Pro-Banthine tablets contain
The active substance in each tablet is propantheline bromide 15mg.
The other ingredients in the tablet are: lactose monohydrate, talc, corn (maize) starch, magnesium stearate and light liquid paraffin.
The sugar coating contains: sucrose, calcium carbonate, saccharin sodium, titanium dioxide (E171), magnesium carbonate light, castor oil virgin, talc, ferric oxide red (E172), ferric oxide yellow (E172) and carnauba wax (see also end of Section 2 for lactose and sucrose).
What Pro-Banthine tablets look like and contents of the pack
Pro-Banthine Tablets are unmarked, pink, sugar-coated tablets.
The tablets are supplied in blister packs containing 100 or 112 tablets or in bottles containing 1000 or 5000 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
This leaflet was last revised in November 2018