READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PATIENT MEDICATION INFORMATION
Hyoscine Butylbromide Tablets
Read this carefully before you start taking BUSCOPAN. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about BUSCOPAN.
What are BUSCOPAN Tablets used for?
For the relief of abdominal spasms (cramps), pain and discomfort in the:
- gut (intestines / bowel),
- biliary tract.
How do BUSCOPAN Tablets work?
- Abdominal cramps (spasms) are caused by sudden, strong tightening of muscles.
- Relieves cramps (spasms), pain, discomfort by relaxing tight muscles of the:
- gut (intestines / bowel),
- biliary tract.
What are the ingredients in BUSCOPAN Tablets?
Medicinal Ingredient: Hyoscine butylbromide.
Non-medicinal Ingredients: Acacia, anhydrous dibasic calcium phosphate, carnauba wax, colloidal silicon dioxide, corn starch, modified starch, polyethylene glycol 6000, povidone, stearic acid, sucrose, talc, tartaric acid, titanium dioxide, and white wax.
BUSCOPAN comes in the following dosage forms:
Tablets, 10 mg.
Do not use BUSCOPAN Tablets if you:
- are allergic to:
- hyoscine butylbromide.
- any of the ingredients in the product (see list in What are the ingredients in BUSCOPAN Tablets).
- have any of the below conditions:
- muscle wasting disease (myasthenia gravis).
- untreated high pressure inside of your eye (closed-angle glaucoma).
- narrowing parts of the gastrointestinal tract (stenosis).
- problems with urination due to prostate issues.
- your intestine stopped working or may be blocked;
- Symptoms include:
- Severe abdominal pain with absence of stools,
- Symptoms include:
- enlarged bowel (megacolon).
- are pregnant, likely to get pregnant, or are breast-feeding.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take BUSCOPAN. Talk about any health conditions or problems you may have, including if you:
- are a man and have prostate problems.
- If you are at risk of narrow angle glaucoma (high pressure in the eyes)
- If you are at risk of having problems with urinating due to a blockage
- If you are at a risk of tachyarrhythmia (high heart rate)
- have stomach acid backing up in your throat (reflux-esophagitis).
- Have or are at risk of any blockage in your gastrointestinal tract. This includes your esophagus, stomach, intestines and anus.
- have inflamed bowels (e.g. ulcerative colitis).
- have a fructose (a sugar) intolerance. BUSCOPAN contains sucrose (a sugar) so you should not take this medication.
Other warnings you should know about:
You should not be taking BUSCOPAN daily for a long period of time. Your healthcare professional should investigate the cause of your stomach pain. Talk to your healthcare professional about how long you should be taking BUSCOPAN.
If the following occurs after you take BUSCOPAN, get medical help immediately:
- if you have severe and unexplained stomach pain that does not go away or gets worse
- if you have severe and unexplained stomach pain that occurs with other symptoms such as:
- changes in bowel movements
- abdominal tenderness
- decreased blood pressure
- blood in stool
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines. The following may interact with BUSCOPAN:
If you are taking antacids or adsorbent anti-diarrheals, your healthcare professional may tell you to take them at least 1 hour before taking BUSCOPAN.
How to take BUSCOPAN Tablets:
Usual dose (Adults):
- Take 1 to 2 tablets per day. Do not take more than 6 tablets per day.
- In prolonged illness, your doctor may recommend taking one tablet 3 to 5 times a day. Do not take more than directed.
- Swallow tablets whole with a glass of water.
Overdose: If you think you have taken too much BUSCOPAN, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
In case a dose has been missed, take the next dose as scheduled. Do not double the dose.
What are the possible side effects from using BUSCOPAN Tablets?
This drug may sometimes cause:
- dry mouth.
- feeling hot and decreased sweating.
- increased heart rate.
- not being able to pass urine.
- increase fluid pressure inside of the eye.
- other rare side effects such as:
- allergic reactions (skin rash and itching).
- skin reactions (e.g. hives, rash, skin redness, itching).
- rapid swelling of the skin and skin tissue (angioedema).
- difficulty in breathing (usually in patients who suffer with asthma or allergy).
There have been very rare reports of severe, allergic reactions and severe allergic shock.
If you experience any of these effects which persist or become troublesome or any side effects not listed here, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Protect from light and heat. Store at room temperature (15 - 30oC). Product is stable up to the labelled expiry.
Keep out of reach and sight of children.
If you want more information about BUSCOPAN:
- Talk to your healthcare professional.
- Find the full Prescribing Information that is prepared for healthcare professionals by visiting the Health Canada website (https://www.canada.ca/en/health-canada.html); or by contacting the sponsor, Sanofi Consumer Health Inc., by visiting www.sanofi.ca or by calling 1-800-636-3664.
This leaflet was prepared by Sanofi Consumer Health Inc., Laval, Quebec H7V 0A3 and is accessible here: https://products.sanofi.ca/en/buscopan.pdf
Last revised: March 31, 2021
*Buscopan® is a substance that blocks the effect of acetylcholine (neurotransmitter). Side affects are generally mild and limited.