BUSCOPAN

Main information

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

Documents

Localization

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

Other information

Status

  • 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:

48256

BUSCOPAN hyoscine butylbromide 10mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

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

Postal Address

PO Box 403,VIRGINIA, QLD, 4014

Australia

ARTG Start Date

3/08/1994

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

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.

Products

1. BUSCOPAN hyoscine butylbromide 10mg tablet blister pack

Product Type

Single Medicine Product

Effective date

23/06/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Spasm of the gastrointestinal tract

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

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

Components

1.

Dosage Form

Tablet, sugar coated

Route of Administration

Oral

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

CMI0062-10

Buscopan

Tablets

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

pharmacist.

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

medicine.

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

Buscopan

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

skin.

Do not take this medicine if you

have fructose intolerance.

Buscopan contains sucrose as an

ingredient.

Do not take Buscopan if you

have:

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

colon

tachyarrhythmia – a fast heart

rate

achalasia – a condition that

causes difficulty in swallowing

food

prostatic hypertrophy – prostate

problems.

Buscopan must not be used when

there is a blockage in the stomach

or bowel or in certain conditions

when there is reduced bowel

activity.

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

established.

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

disposal.

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

like:

fever

nausea

vomiting

changes in bowel movements

fainting

blood in faeces.

Tell your doctor if you are

pregnant or plan to become

pregnant or are breastfeeding.

CMI0062-10

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

Buscopan.

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

include:

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

condition.

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

medicines.

Your doctor and pharmacist have

more information on medicines to

be careful with or avoid while

taking this medicine.

How to take

Buscopan

Follow all directions given to you

by your doctor or pharmacist

carefully.

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

you.

This medicine helps to control your

condition, but does not cure it.

Do not take it for extended

periods.

Worsening or persistent stomach

pain should be investigated by your

doctor to determine the cause of the

pain.

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

missed.

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

pack

If you take too much

(overdose)

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

Buscopan

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

medicine.

Tell your doctor or pharmacist if

the pain is severe or does not

CMI0062-10

improve within 48 hours of taking

Buscopan.

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

people.

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

Buscopan.

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

Buscopan.

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

rash

itching

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

hospital:

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

hospitalisation.

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

Buscopan

Storage

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.

Disposal

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

Australia.

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.

Ingredients

Buscopan contains 10 mg of

hyoscine butylbromide as the active

ingredient.

It also contains in the tablet core:

calcium hydrogen phosphate

maize starch

soluble starch

colloidal anhydrous silica

tartaric acid

CMI0062-10

stearic acid.

The sugar coating contains:

sucrose

povidone, purified talc

acacia

titanium dioxide

macrogol 6000

carnauba wax

white beeswax.

Supplier

Buscopan is supplied in Australia

Boehringer Ingelheim Pty Limited

ABN 52 000 452 308

78 Waterloo Road

NORTH RYDE NSW 2113

Buscopan is supplied in New

Zealand by:

Boehringer Ingelheim (N.Z.)

Limited

Auckland

New Zealand

This leaflet was prepared in May

2013.

BUSCOPAN is a registered

trademark of Boehringer Ingelheim

Boehringer Ingelheim Pty

Limited 2013