Buscopan Consumer Medicine Information
|Manufacture:||Boehringer Ingelheim Pharmaceuticals, Inc.|
|Condition:||Muscle Spasm (Involuntary Hypertonicity), Spasms (Muscle Spasm)|
|Form:||Liquid solution, Subcutaneous (SC), Intramuscular (IM), Intravenous (IV), Tablets|
|Ingredients:||hyoscine butylbromide, acacia, carnauba wax, castor oil, lactose, magnesium stearate, maize starch, sucrose, polyethylene glycol, shellac, talc, tartaric acid, titanium dioxide, and white wax; sodium chloride and water for injection|
About this medication
What the medication is used for
BUSCOPAN tablets are used for the relief of smooth muscle spasm (cramps) of the gastrointestinal and genitourinary system.
BUSCOPAN ampoules are used for relief of acute genitourinary or gastrointestinal spasm, or to produce smooth muscle relaxation prior to radiological procedures where spasm may be a problem.
What it does
Stomach cramps are caused by sudden, irregular tightening up of muscles in the wall of the intestine. BUSCOPAN works by relaxing the tight muscles, so relieving the cramps.
When it should not be used
Do not use Buscopan if
- You are hypersensitive (allergic) to hyoscine butylbromide or atropinics or to any of the nonmedicinal ingredients (See What the important nonmedicinal ingredients are).
- You have myasthenia gravis (a muscle wasting disease), megacolon (enlarged colon), untreated narrow angle glaucoma or obstructive prostatic hypertrophy (enlarged and blocked prostate).
- You have myasthenia gravis, untreated narrow angle glaucoma, difficulty in urination due to inflammation of the prostate, stenotic lesions (narrowing of a duct/canal) of the gastrointestinal tract, tachycardia (fast heartbeat), angina, heart failure and megacolon (enlarged colon).
- You are taking Buscopan by the intramuscular route and you are currently being administered anticoagulant drugs (blood thinners) as intramuscular bleeding may occur with this combination.
What the medicinal ingredient is
What the important nonmedicinal ingredients are
Tablets: acacia, carnauba wax, castor oil, lactose, magnesium stearate, maize starch, sucrose, polyethylene glycol, shellac, talc, tartaric acid, titanium dioxide, and white wax.
Ampoules: sodium chloride and water for injection
What dosage forms it comes in
Tablets, 10 mg
Ampoules, 20 mg/mL
Warnings and precautions
BEFORE you use BUSCOPAN talk to your doctor or pharmacist if:
- you are pregnant, likely to become pregnant or if you are breast feeding as it is recommended that you do not use BUSCOPAN in these conditions
- you are a man who suffers from prostate problems
- you have narrow angle glaucoma, megacolon or myasthenia gravis
- you have a very fast heart rate or other heart problems
- you have reflux esophagitis or ulcerative colitis
- you are hypersensitive or “allergic” to hyoscine-N-butylbromide or any of the other ingredients
- you have previously been treated by a doctor for a severe sweating disorder
- you are taking antidepressants, major tranquilizers, antihistamines, antivirals, dopamine antagonists (e.g. metoclopramide) or medicines to treat heart problems
- you have sudden or severe abdominal pain along with symptoms such as fever, nausea, vomiting, blood in the stool, or low blood pressure (e.g., lightheadedness) , contact your doctor immediately
- you have a rare hereditary condition of fructose (a sugar) intolerance you should not take this medication as it contains lactose.
If in doubt, ask your doctor or pharmacist.
If you experience dizziness or blurred vision, avoid driving or operating machinery.
Interactions with this medication
Drugs that may interact with BUSCOPAN include: tricyclic antidepressants, antihistamines, quinidine, disopyramide, amantadine, MAO inhibitors, anticholinergics, dopamine antagonists such as metoclopramide, beta-adrenergic agents, antacids or adsorbent antidiarrheals.
Proper use of this medication
Usual adult dose
Tablets: One to two 10 mg tablets per day up to a maximum of 6 tablets per day. In prolonged illness, the doctor may recommend repeated dosing of one tablet 3 to 5 times a day. Swallow tablets whole with a glass of water.
Ampoules: One half (10 mg/0.5 mL) to one ampoule (20 mg/mL) administered parenterally by intramuscular, subcutaneous, or intravenous routes, at an injection rate of 1 mL/min. No dilutions of the ampoule is necessary prior to administration. The maximum dose should not exceed 100 mg/day (5 ampoules).
In case of drug overdose, contact a health care practitioner (or doctor), hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
When using the product, you should not take more doses than directed. Particularly in the case of overdose, the side effects listed below may be observed.
Your doctor will advise you that certain antacids or adsorbent antidiarrheals should be taken at least one hour before BUSCOPAN.
In case a dose has been missed, take the next dose as scheduled. Do not double the dose.
Side effects and what to do about them
After taking BUSCOPAN tablets
All medicines sometimes cause side-effects. BUSCOPAN may occasionally cause a dry mouth, blurred vision, mydriasis (pupil dilation), increased eye pressure, diarrhea, nausea, reduced ability to sweat, an increase in heart rate and the inability to pass urine.
Other possible rare side-effects include, dizziness, flushing, allergic reactions (particularly skin rash and itching), skin reactions (e.g., hives, rash, skin redness, itching), angioedema (swelling of the lips), decreased blood pressure, and difficulty in breathing (usually in patients who suffer with asthma or allergy).
There have been very rare reports of anaphylactic (severe, allergic) reactions and anaphylactic shock including death.
If you experience any of these effects and they persist or become troublesome, consult your doctor.
Should you suffer from a painful red eye with loss of vision, seek urgent medical advice.
If you experience any other effects not mentioned above, consult your doctor or pharmacist.
This is not a complete list of side effects. For any unexpected effects while taking BUSCOPAN, contact your doctor or pharmacist.
How to store it
BUSCOPAN tablets and ampoules should be protected from light and heat.
BUSCOPAN ampoules should be protected from freezing.
Products should be stored at room temperature (15 - 30°C) and are stable up to the expiration date indicated on the label.
Keep out of reach of children.
Reporting suspected side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Postal Locator 0701E
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE:Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
This document plus the Prescribing Information, prepared for health professionals can be found at:
or by contacting the sponsor, Boehringer Ingelheim (Canada)
1-800-263-5103 ext. 84633
This leaflet was prepared by Boehringer Ingelheim (Canada) Ltd.
Last revised: October 7, 2014