Main information

  • Trade name:
  • BUSCOPAN hyoscine butylbromide 10mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug



  • Available in:
  • BUSCOPAN hyoscine butylbromide 10mg tablet blister pack
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 48256
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


BUSCOPAN hyoscine butylbromide 10mg tablet blister pack

ARTG entry for

Medicine Registered


Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare

Postal Address

PO Box 403,VIRGINIA, QLD, 4014


ARTG Start Date


Product category




Approval area

Drug Safety Evaluation Branch


Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.


1. BUSCOPAN hyoscine butylbromide 10mg tablet blister pack

Product Type

Single Medicine Product

Effective date



See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Spasm of the gastrointestinal tract

Additional Product information

Container information



Life Time




Blister Pack

Not recorded

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S2) Pharmacy Medicine

(S2) Pharmacy Medicine



Dosage Form

Tablet, sugar coated

Route of Administration


Visual Identification

Round, white, biconvex sugar coated tablet.

Active Ingredients

Hyoscine butylbromide

10 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 01.12.2017 at 10:59:09 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation




Hyoscine butylbromide

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Buscopan tablets.

It does not contain all available

information. It does not take the

place of talking to your doctor or


This leaflet was last updated on the

date at the end of this leaflet. More

recent information may be

available. The latest Consumer

Medicine Information is available

from your pharmacist, doctor, or

from www.medicines.org.au and

may contain important information

about the medicine and its use of

which you should be aware.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking Buscopan

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this information with the


You may need to read it again.

What Buscopan is

used for

Buscopan is known as an

anticholinergic medicine. It relieves

the pain of stomach and bowel

cramps by helping your digestive

system to relax.

Buscopan blister packs of 20 tablets

are available only at a pharmacy.

Buscopan blister packs of 100

tablets are available only with a

doctor's prescription.

Always consult your doctor or

pharmacist if the pain does not

improve within 48 hours or if

pain worsens after treatment.

Before you take


When you must not take it

Do not take Buscopan if you are

allergic to hyoscine butylbromide

or to any of the other ingredients

listed at the end of this leaflet.

Some of the symptoms of an

allergic reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the


Do not take this medicine if you

have fructose intolerance.

Buscopan contains sucrose as an


Do not take Buscopan if you


myasthenia gravis - a condition

in which the muscles become

weak and tire easily

glaucoma - high pressure in the

porphyria – a rare blood

pigment disorder

megacolon - a condition of the


tachyarrhythmia – a fast heart


achalasia – a condition that

causes difficulty in swallowing


prostatic hypertrophy – prostate


Buscopan must not be used when

there is a blockage in the stomach

or bowel or in certain conditions

when there is reduced bowel


These conditions are best

explained by your doctor or

pharmacist. Do not give it to a

child under the age of 6 years.

Safety and effectiveness in children

younger than 6 years have not been


Do not take it after the expiry

date printed on the pack or if the

packaging is torn or shows signs

of tampering.

If it has expired or is damaged,

return it to your pharmacist for


If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take it

Tell your doctor immediately if

your abdominal pain continues or

worsens or occurs with symptoms





changes in bowel movements


blood in faeces.

Tell your doctor if you are

pregnant or plan to become

pregnant or are breastfeeding.


There is limited information on the

use of Buscopan during pregnancy

and breastfeeding.

Your doctor can discuss with you

the risks and benefits involved.

If you have not told your doctor

about any of the above, tell

him/her before you start taking


Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines and Buscopan may

interfere with each other. These


medicines used to treat or

prevent nausea and vomiting

such as metoclopramide

medicines used to treat malaria

such as quinine

medicines used to treat the

symptoms of Parkinson's

disease such as amantadine

medicines used to treat some

mental conditions such as tri

and tetracyclic antidepressants

and antipsychotics

medicines used to treat allergies

such as antihistamines

medicines for the treatment of

depression, heart disease or

respiratory disease such as

tiotropium, ipratropium or

atropine-like compounds

any other medicine for the

treatment of stomach or bowel


These medicines may be affected by

Buscopan or may affect how well it

works. You may need different

amounts of your medicines, or you

may need to take different


Your doctor and pharmacist have

more information on medicines to

be careful with or avoid while

taking this medicine.

How to take


Follow all directions given to you

by your doctor or pharmacist


They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

How much to take

The recommended dose for adults

and children over 6 years of age is

two tablets four times a day taken

about every 4-6 hours.

How to take it

Swallow the tablets whole with a

glass of water.

How long to take it

Continue taking your medicine

for as long as your doctor tells


This medicine helps to control your

condition, but does not cure it.

Do not take it for extended


Worsening or persistent stomach

pain should be investigated by your

doctor to determine the cause of the


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 it as soon as you

remember, and then go back to

taking your medicine as you

would normally.

Do not take a double dose to

make up for the dose that you


This may increase the chance of you

getting an unwanted side effect.

If you are not sure what to do, ask

your doctor or pharmacist.

If you no longer have any

stomach pain it is not necessary to

finish taking all the tablets in the


If you take too much


Seek medical advice if you have

used more than the recommended

or prescribed dose of Buscopan.

Symptoms of an overdose may

include: drowsiness, dry mouth,

difficulty passing urine, reddening

of the skin, decreased

gastrointestinal tract movement, fast

heart rate and sight disturbances.

Advice can be provided by a

doctor, pharmacist or Poisons

Information Centre (in Australia

telephone 13 11 26; in New

Zealand telephone 0800 764 766).

Do not drive a car or operate

machinery if you have taken more

than the recommended or

prescribed dose of Buscopan.

While you are taking


Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking Buscopan.

Tell your doctor or pharmacist if

you begin taking any other

medicine while you are taking this


Tell your doctor or pharmacist if

the pain is severe or does not


improve within 48 hours of taking


Cramps in the stomach or bowel

may be temporary or may signal the

presence of a more serious problem.

Things to be careful of

Be careful driving or operating

machinery until you know how

Buscopan affects you.

This medicine may cause dizziness,

tiredness, drowsiness in some


If you have any of these

symptoms, do not drive, operate

machinery or do anything else

that could be dangerous.

Do not drink alcohol while taking


Alcohol may increase the chance of

side effects such as drowsiness.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking


All medicines can have side effects.

Sometimes they are serious, most of

the time they are not.

Ask for the advice of your doctor

or pharmacist if you have any

concerns about the effects of

taking this medicine.

Do not be alarmed by the

following lists of side effects. You

may not experience any of them.

Tell your doctor or pharmacist if

you notice any of the following

and they worry you:

dry mouth

fast heart rate

reduced sweating



redness of the skin

a skin condition called

dyshidrosis (small blisters on

the hands and feet)

difficulty passing urine.

There have also been very rare

isolated reports of coma,

hallucinations (seeing, feeling or

hearing things that are not there),

dystonia (unusual muscle tone

causing distortion of the body),

confusion, agitation and dizziness.

These side effects were relieved

when the patients stopped Buscopan

therapy and received appropriate

medical treatment.

If any of the following happen,

tell your doctor immediately or go

to Emergency at your nearest


allergic reactions (such as skin

rashes, or swelling of the face

and difficulty in breathing)

sudden life-threatening allergic

reactions (anaphylaxis with

episodes of shortness of breath

and shock).

Allergic reactions can be very

serious side effects. You may need

urgent medical attention or


Tell your doctor or pharmacist if

you notice anything that is

making you feel unwell.

Other side effects not listed above

may also occur in some people.

After taking



Keep your tablets in the pack

until it is time to take them.

If you take the tablets out of the

pack they may not keep well.

Keep your tablets in a cool dry

place where the temperature stays

below 25°C.

Do not store Buscopan or any

other medicine in the bathroom

or near a sink.

Do not leave it on a window sill or

in the car.

Heat and dampness can damage

some medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.


If the expiry date has passed, ask

your pharmacist what to do with

any medicine that is left over.

Product Description

Buscopan is available in blister

packs of 10*, 20 and 100 tablets.

Australian Registration number on

outer carton is AUST R 48256.

* Not currently distributed in


What it looks like

Buscopan tablets are small, shiny

and white in colour.

Buscopan blister packs of 20 tablets

are available only at a pharmacy.

Buscopan blister packs of 100

tablets are available only with a

doctor's prescription.


Buscopan contains 10 mg of

hyoscine butylbromide as the active


It also contains in the tablet core:

calcium hydrogen phosphate

maize starch

soluble starch

colloidal anhydrous silica

tartaric acid


stearic acid.

The sugar coating contains:


povidone, purified talc


titanium dioxide

macrogol 6000

carnauba wax

white beeswax.


Buscopan is supplied in Australia

Boehringer Ingelheim Pty Limited

ABN 52 000 452 308

78 Waterloo Road


Buscopan is supplied in New

Zealand by:

Boehringer Ingelheim (N.Z.)



New Zealand

This leaflet was prepared in May


BUSCOPAN is a registered

trademark of Boehringer Ingelheim

Boehringer Ingelheim Pty

Limited 2013