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 taking Buscopan Forte?
Buscopan Forte contains the active ingredient hyoscine butylbromide. Hyoscine butylbromide is an anticholinergic medicine. Buscopan Forte is used to relieve the pain of stomach and bowel cramps by helping
your digestive system to relax.
2. What should I know before I take Buscopan Forte?
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.
4. How do I take Buscopan Forte?
The recommended dose for adults and children 6 years and over is one tablet taken
four times a day (about every 4 to 6 hours). Do not take Buscopan Forte for longer
than 2 to 3 days at a time except on the recommendation of your doctor. If you no
longer have any stomach pain it is not necessary to finish taking all the tablets
in the pack.
5. What should I know after taking Buscopan Forte?
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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 taking Buscopan Forte.
Before you take any other medicine, talk to your doctor or pharmacist.
Remind any doctor, dentist, or pharmacist you visit that you are taking Buscopan Forte.
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Things you should not do
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Do not drink alcohol after taking Buscopan Forte.
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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 dry mouth, redness of the skin, fast heart rate,
difficulty passing urine, abnormal sweating, reduced sweating. A serious side effect
is an allergic reaction with symptoms of shortness of breath, wheezing or difficulty
breathing, swelling of the face, lips tongue or other parts of the body, itch, hives,
or rash 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 Forte tablets. 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 Forte.
Where to find information in this leaflet:
1. Why am I taking Buscopan Forte?
Buscopan Forte contains the active ingredient hyoscine butylbromide. Hyoscine butylbromide is an anticholinergic medicine. Buscopan Forte is used to relieve the pain of stomach and bowel cramps by helping
your digestive system to relax.
2. What should I know before I take Buscopan Forte?
Warnings
Do not take Buscopan Forte 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 galactose intolerance, such as galactosaemia, the Lapp lactase deficiency
or glucose-galactose malabsorption. Buscopan Forte contains lactose.
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 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
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.
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.
Children
Do not give it to a child 6 years of age or under.
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.
Some medicines and Buscopan Forte 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
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 Forte.
4. How do I take Buscopan Forte?
How much to take and how long to take it
Follow the instructions provided and take Buscopan Forte until your doctor tells you
to stop.
The recommended dose for adults and children over 6 years of age is one tablet four
times a day taken about every 4 - 6 hours).
If you no longer have any stomach pain it is not necessary to finish taking all the
tablets in the pack.
Do not take it for extended periods. Do not take Buscopan Forte for longer than 2
- 3 days at a time except on the recommendation of a doctor.
One pack of Buscopan Forte (10 tablets) is enough for 2½ days treatment at the recommended
dose.
Worsening or persistent stomach pain should be investigated by your doctor to determine
the cause of the pain.
How it is taken
Swallow the tablets whole with a glass of water.
If you forget to take Buscopan Forte
If you miss your dose at the usual time and it is almost time for your next dose,
skip the dose you missed and take your dose when you are next meant to.
Otherwise, take it as soon as you remember and then go back to taking your medicines
as you normally would.
Do not take a double dose to make up for the dose you missed.
If you take too much Buscopan Forte
If you think you have taken too much Buscopan Forte, you may need urgent medical attention.
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.
You should do this even if there are no signs of discomfort or poisoning.
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.
Do not drive a car or operate machinery if you have taken more than the recommended
or prescribed dose of Buscopan Forte.
5. What should I know after taking Buscopan Forte?
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 taking Buscopan Forte.
Cramps in the stomach or bowel may be temporary or may signal the presence of a more
serious problem.
your abdominal pain continues or worsens or occurs with symptoms like:
fever
nausea
vomiting
changes in bowel movements
fainting
blood in faeces
Remind any doctor, dentist, or pharmacist you visit that you are taking Buscopan Forte.
Drinking Alcohol
Do not drink alcohol after taking Buscopan Forte.
Alcohol may increase the chance of side effects such as drowsiness.
Looking after your medicine
Store below 30°C.
Keep your tablets in the pack until it is time to take them.
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.
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
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
Buscopan Forte is available in blister packs of 10 tablets from a pharmacy.
What Buscopan Forte contains
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Active ingredient
(main ingredient)
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20 mg of hyoscine butylbromide per tablet
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Other ingredients
(inactive ingredients)
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Tablet Core
povidone
lactose monohydrate
microcrystalline cellulose
magnesium stearate
Tablet Coating
proprietary ingredient
Opadry II White 85G18490
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Potential allergens
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Lactose
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Do not take this medicine if you are allergic to any of these ingredients.
Do not take this medicine if you have galactose intolerance, such as galactosaemia,
the Lapp lactase deficiency or glucose-galactose malabsorption. Buscopan Forte contains
lactose.
What Buscopan Forte looks like
Buscopan Forte tablets are white, round, biconvex film-coated tablets embossed with
the letter ‘B’ on one side and the number ‘20‘ on the other side (Aust R 153552).
Who distributes Buscopan Forte
Buscopan Forte is made in France.
In Australia:
Sanofi Consumer Healthcare
87 Yarraman Place
Virginia Qld 4014
Australia
Toll-Free: 1800 818 806
In New Zealand:
Sanofi-Aventis New Zealand Limited
Level 8, 56 Cawley Street
Ellerslie, Auckland
New Zealand
Toll-free: 0800 283 684
This leaflet was prepared in September 2020.
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