Skip to Content

PRO-BANTHINE TABLETS 15MG

Active substance: PROPANTHELINE BROMIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACK AGE 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.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if their signs of
illness are the same as yours.
• If you get any side effects talk to you doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
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

Pharmacode
placeholder

Do not take Pro-Banthine tablets if you have:
• an allergy to propantheline bromide or any of the other
ingredients of Pro-Banthine (see Section 6, and also end
of Section 2)
• an obstruction in your gut (gastrointestinal tract), or it is
inflamed or does not function normally. These may show
themselves as abdominal pain, bloating, reflux or fever
• a partial or complete blockage of the bowel that leads to
constipation or bloating of the stomach (paralytic ileus)
• toxic megacolon (a very dilated colon accompanied by
bloating and sometimes fever, abdominal pain or shock)
• a hiatus hernia (a condition in which a portion of the
stomach protrudes upward into the chest, through an
opening in the diaphragm)
• pyloric stenosis (a narrowing of the outlet from your
stomach which delays food passing out of your stomach
and may lead to vomiting)
• severe ulcerative colitis (ulcers and inflammation in the
large bowel), as Pro-Banthine tablets may worsen the
condition
• any obstruction in your urinary tract
• a muscle weakening disease such as myasthenia gravis
or weakness of the intestinal muscles
• heart problems following severe bleeding
• an enlarged prostate gland
• an eye disease called closed angle glaucoma.
Warning and Precautions
Talk to your doctor or pharmacist before taking
Pro-Banthine if any of the following conditions applies to you:
• pregnancy, likely to become pregnant or are breast-feeding
• elderly
• diarrhoea, especially if you have a colostomy (opening of
the colon by surgery) or ileostomy (opening of the small
intestine by surgery)
• severe heart disease, especially if an increase in heart
rate is undesirable, or an irregular heart beat, heart









failure, reduced heart function or any other heart
problem (coronary heart disease, congestive heart
failure, cardiac arrhythmias)
gastrointestinal reflux
a fever
ulcerative colitis (ulcers and inflammation in the large
bowel) as taking Pro-Banthine tablets may result in lifethreatening complications of other intestinal conditions
autonomic neuropathy (a disease of the nervous system
affecting the bladder muscles, the heart, the digestive
tract, and the genital organs)
liver or kidney problems
an overactive thyroid gland
high blood pressure

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.
Children
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:
• nefopam (a pain killer): the risk of side effects may
increase if you take Pro-Banthine tablets
• paracetamol: its absorption may be reduced by
Pro-Banthine tablets
• medicines to reduce high blood pressure: Pro-Banthine
tablets may increase the risk of side effects
• anti-diabetic medicines: your insulin requirement may
be reduced if you take Pro-Banthine tablets
• antidepressants: Pro-Banthine tablets may increase the
risk of side effects
• disopyramide (to treat irregular heartbeat): ProBanthine tablets may increase the risk of side effects
• ketoconazole (to treat fungal infections): Pro-Banthine
tablets may reduce its absorption
• nitrofurantoin (to treat infections): Pro-Banthine tablets
may enhance its absorption
• antihistamines: Pro-Banthine tablets may increase the
risk of side effects
• antimuscarinic drugs such as belladonna alkaloids (to
affect the nervous system): Pro-Banthine tablets may
increase the risk of side effects
• haloperidol (to treat psychosis): Pro-Banthine tablets
may reduce its effects
• clozapine or phenothiazines (to treat psychosis): ProBanthine tablets may increase the risk of side effects
• digoxin (to treat heart failure): taking Pro-Banthine
tablets with slow-dissolving digoxin tablets may cause
increased digoxin levels in your blood
• domperidone (to treat nausea and vomiting):
Pro-Banthine tablets may reduce its effects on
gastrointestinal activity
• amantadine (to treat Parkinson’s disease and some viral
infections): Pro-Banthine tablets may increase the risk of
side effects
• levodopa (to treat Parkinson’s disease): Pro-Banthine
tablets may reduce its absorption
• memantine (to treat dementia in Alzheimer’s disease):
the effects of Pro-Banthine tablets may be enhanced by
memantine
• metoclopramide (to treat nausea, vomiting and
migraine): Pro-Banthine tablets may reduce its effects on
gastrointestinal activity
• nitrates (to treat angina): Pro-Banthine tablets may
reduce the effects of sublingual nitrate tablets (failure to
dissolve under the tongue owing to dry mouth)

Pharmacode
placeholder

Propantheline bromide

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
Lactose and sucrose are ingredients present in ProBanthine tablets – if you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor
before taking this product.
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.
Elderly:
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.
Children:
Pro-Banthine tablets are not recommended for use in
children.

Pharmacode
placeholder

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, delirium, convulsion, circulatory failure,
respiratory depression, paralysis of voluntary muscles
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:
• Eye pain, severe difficulty focusing your eyes or being
very sensitive to light
• Severe difficulty urinating and emptying the bladder.
Tell your doctor if you experience any of the following:
• increase or decrease in your heart rate; palpitations
(unpleasant or unusual sensation of your heart beating)
or irregular heartbeat

• constipation
• nausea (feeling sick) and vomiting
• dry mouth, feeling thirsty and finding it difficult to
swallow
• dry skin, feeling hot with reddening of the face and neck
but with very little sweating, heat stroke
• dryness of the airways (this may make it difficult to
cough up phlegm)
• confusion in the elderly
• dizziness.
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 or pharmacist.
This includes any possible side effects not listed in this
leaflet.
You can also report side effects (see details below).
By reporting side effects you can help provide more
information on the safety of this medicine.
United Kingdom: Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard.
Ireland: HPRA Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2.
Tel: +353 1 6764971, Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie
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 25ºC.
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, corn (maize) starch, talc, light liquid paraffin
and magnesium stearate.
The sugar coating contains: sucrose, calcium carbonate,
saccharin sodium, titanium dioxide (E171), magnesium
carbonate, castor oil, talc, red iron oxide (E172), ochre
no.1624 (E172), carnauba wax and water.
(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
Archimedes Pharma UK Limited
Galabank Business Park, Galashiels,
TD1 1QH, United Kingdom
Manufacturer
Haupt Pharma Wülfing GmbH
Bethelner Landstrasse 18
31028 Gronau
Germany
PL 12406/0026
PA 0757/009/001
This leaflet was last revised in April 2015.

LFT-PRB-GB-002

Pharmacode
placeholder

• parasympathomimetics (drugs that are used to affect
the nervous system e.g. stimulating digestive secretions;
slowing the heart; constricting the pupils; dilating blood
vessels): Pro-Banthine tablets may reduce the effects of
these drugs.



Yellowdot Design Artwork Technical Specifications


DESCRIPTION: Pro-Banthine UK/IRE 15mg UK PIL

PRODUCT No.: LFT-PRB-GB-002

INTERNAL CODE No.:

Cutterguide ref.:

VERSION No.: 3

DATE: 07/04/2015

YELLOWDOT REF:

REASON FOR CHANGE: Change this to update the address to

Galabank Business Park...


SIZE: 249mm high x 158mm wide

COLOURS: Black

TEXT SIZE: 7pt

LEADING: 8pt (2.85mm)

FONTS: ITC New Baskerville

Expand view ⇕

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.

Hide