Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I given Buscopan?
Buscopan contains the active ingredient hyoscine butylbromide. Hyoscine butylbromide is an anticholinergic medicine. Buscopan is used to relieve the pain of stomach and bowel cramps by helping your digestive
system to relax. It is also used to help relax gallbladder spasms and kidney spasms,
and as a diagnostic aid in radiology.
2. What should I know before I receive Buscopan?
Do not use if you have ever had an allergic reaction to hyoscine butylbromide or any
of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking or using any other medicines including
any that you get without a prescription from your pharmacy, supermarket, or health
food shop. Buscopan must not be given in the muscle if you are being treated with
anticoagulant medicines.
4. How do I receive Buscopan?
Your doctor will decide what dose you will receive and the duration of treatment.
Buscopan is administered by a doctor or nurse. It is given by deep injection into
a muscle (e.g. the buttock, upper leg or upper arm) or slow injection into a vein.
5. What should I know after being given Buscopan?
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Things you should do
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Call your doctor straight away if the pain is severe or does not improve within 48
hours of being given Buscopan.
Before you take any other medicine, talk to your doctor or pharmacist.
Remind any doctor, dentist, or pharmacist you visit that you have received Buscopan.
Be careful before you drive or use any machines or tools until you know how Buscopan
affects you.
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Things you should not do
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Do not drink alcohol after receiving Buscopan.
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Looking after your medicine
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Store below 30°C.
Store in a cool, dry place away from moisture, heat, or sunlight.
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6. Are there any side effects?
Less serious side effects include redness of the skin, itching, a skin condition called
dyshidrosis, rash, abnormal sweating, reduced sweating, fast heart rate, drop in blood
pressure, dry mouth, flushing, difficulty with passing urine, shortness of breath,
dizziness, and temporary blurred vision due to reduce eye focusing. Serious side effects
are allergic reactions (such as skin rashes, or swelling of the face and difficulty
in breathing) and sudden life-threatening allergic reactions (anaphylaxis with episodes
of shortness of breath and shock).
Active ingredient:
hyoscine butylbromide
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Buscopan. You should also speak to your doctor, or pharmacist if you would like further information
or if you have any concerns or questions about using Buscopan.
Where to find information in this leaflet:
1. Why am I given Buscopan?
Buscopan contains the active ingredient hyoscine butylbromide. Hyoscine butylbromide is an anticholinergic medicine. Buscopan is used to relieve the pain of stomach and bowel cramps by helping your digestive
system to relax. It is also used to help relax gallbladder spasms and kidney spasms,
and as a diagnostic aid in radiology.
Buscopan reduces the peristalsis (wave-like contractions) of smooth muscle resulting
in relief from spasms in certain organs in the digestive system.
2. What should I know before I receive Buscopan?
Warnings
Do not receive Buscopan if:
you are allergic to hyoscine butylbromide, or any of the 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
Always check the ingredients to make sure you can use this medicine.
you have myasthenia gravis - a condition in which the muscles become weak and tire
easily.
you have glaucoma - high pressure in the eye
you have porphyria - a rare blood pigment disorder
you have a suspected or confirmed blockage of the bowel or stomach
you have a weakened intestinal muscles (intestinal atony)
you have a condition where the bowel is blocked and does not work properly (paralytic
or obstructive ileus). Symptoms include severe abdominal pain with lack of stools
and/or nausea/vomiting.
you have a very enlarged bowel (megacolon)
you have a fast heart rate (tachyarrhythmia)
you have a condition that causes difficulty in swallowing food (achalasia)
you have prostate problems - prostatic hypertrophy
you are taking anticoagulants medicines and Buscopan will be given in the muscle
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
Check with your doctor if you:
you have any other medical conditions
you take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or plan to breastfeed.
3. What if I am taking other medicines?
Tell your doctor, or pharmacist if you are taking or using any other medicines, including
any medicines, vitamins or supplements that you buy without a prescription from your
pharmacy, supermarket or health food shop.
Buscopan must not be given in the muscle if you are being treated with anticoagulant
medicines.
Some medicines and Buscopan may interfere with each other:
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 conditions
medicine used to treat certain conditions, such as disopyramide
Check with your doctor, or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Buscopan.
4. How do I receive Buscopan?
How much to be given
Your doctor will decide what dose you will receive. This depends on your condition
and other factors.
The recommended dose is one or two ampoules (20 - 40 milligrams)
The maximum dose per day is 100 milligrams (equivalent to five ampoules).
Your doctor might prescribe a different dose or duration of treatment. If you need
further information, ask your doctor or pharmacist.
Do not use it for extended periods.
Worsening or persistent stomach pain should be investigated by your doctor to determine
the cause of the pain.
How it is given
This medicine should only be given by a doctor or nurse and in a setting where appropriate
equipment is readily available for diagnosis and patient monitoring.
The injections can be given deeply into a muscle (e.g. the buttock, upper leg, or
upper arm) or can be given as a slow injection into the vein.
If you receive too much Buscopan
These injections are given under medical supervision and it is very unlikely that
you will be given too much.
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.
If you think that you have been given too much Buscopan, you may need urgent medical
attention.
Tell your doctor or medical staff immediately if you feel you have been given too
much Buscopan.
You should do this even if there are no signs of discomfort or poisoning.
If you experience any signs of overdose after you leave the doctor or nurse, you should
immediately:
phone the Poisons Information Centre
(by calling
13 11 26 if you are in Australia), or
phone the National Poisons Information Centre
(by calling 0800 POISON or 0800 764 766 if you are in New Zealand), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
5. What should I know after being given Buscopan?
Things you should do
Before you take any other medicine, talk to your doctor or pharmacist.
Call your doctor straight away if:
the pain is severe or does not improve within 48 hours of being given Buscopan.
Cramps in the stomach or bowel may be temporary or may signal the presence of a more
serious problem.
you develop painful, red eye/s with loss of vision.
Remind any doctor, dentist, or pharmacist you visit that you have received Buscopan.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Buscopan
affects you.
Buscopan 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.
Drinking Alcohol
Do not drink alcohol after receiving Buscopan.
Alcohol may increase the chance of side effects such as drowsiness.
Looking after your medicine
Store below 30°C.
Store it in a cool dry place away from moisture, heat or sunlight; for example:
do not store it in the bathroom or near a sink, or
do not store it in the car or on windowsills.
Keep it where young children cannot reach it.
Each ampoule is for single use only.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor, or pharmacist if you
have any further questions about side effects.
Less serious side effects
Very rarely there have also been isolated reports of:
coma,
hallucinations (seeing, feeling, or hearing things that are not there),
unusual muscle tone causing distortion of the body (dystonia),
confusion,
agitation, and
dizziness.
These side effects were relieved when the patients stopped Buscopan therapy and received
appropriate medical treatment.
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Buscopan contains
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Active ingredient
(main ingredient)
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20 mg of hyoscine butylbromide per ampoule
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Other ingredients
(inactive ingredients)
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sodium chloride
water for injections
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Potential allergens
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Not applicable
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Do not take this medicine if you are allergic to any of these ingredients.
What Buscopan looks like
Buscopan 1 mL glass ampoules contain a clear, colourless solution.
Buscopan ampoules are available in packs of 5 ampoules.
Who distributes Buscopan
In Australia:
Sanofi Consumer Healthcare
87 Yarraman Place
Virginia QLD 4014
In New Zealand:
Sanofi-Aventis New Zealand limited
Level 8, 56 Cawley Street
Ellerslie Auckland 1051,
New Zealand
Buscopan is made in Spain.
This leaflet was prepared in September 2020.
buscopaninj-ccdsv01-cmiv3-22sep20
Australian Registration Number
Aust R 17916
BUSCOPAN is a registered trademark of Sanofi Consumer Healthcare
