READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PATIENT MEDICATION INFORMATION. Buscopan Hyoscine Butylbromide Injection

Transcription

1 READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PATIENT MEDICATION INFORMATION Buscopan Hyoscine Butylbromide Injection 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 Ampoules used for? A spasm is the tightening of muscles in the stomach, intestines, bladder or uterus. This drug is used to relax the muscle before medical tests, when muscle spasms may be a problem. How do BUSCOPAN Ampoules work? Cramps are caused by sudden, strong tightening of muscles in the stomach and intestines. This drug relaxes the tight muscles and relieves the cramps. What are the ingredients in BUSCOPAN Ampoules? Medicinal ingredient: Hyoscine butylbromide. Non-medicinal ingredients: Sodium chloride and water for injection. BUSCOPAN comes in the following dosage forms: Ampoules, 20 mg/ml hyoscine butylbromide. Tablets, 10 mg hyoscine butylbromide. Do not use BUSCOPAN Ampoules if you: are allergic to: hyoscine butylbromide. atropinics. any of the ingredients in the product (see list in What are the ingredients in BUSCOPAN Ampoules). are taking this drug by injection into the muscle and you are taking blood thinners (anticoagulants). Taking the drugs at the same time may cause bleeding in the muscle. have any of the below conditions: muscle wasting disease (myasthenia gravis). untreated high pressure inside of your eye (closed-angle glaucoma). problems with urination due to prostate issues. narrowing parts of the gastrointestinal tract (stenosis). fast heartbeat (tachycardia). heart failure. chest pain and short breath (angina). enlarged bowel (megacolon). 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 pregnant or plan to become pregnant, breastfeeding or plan to breastfeed. you should not use this drug if you are pregnant or breastfeeding. are a man and have prostate problems. have stomach acid backing up in your throat (reflux-esophagitis). have inflamed bowels (e.g. ulcerative colitis). were treated in the past for a severe sweating problem. Buscopan Prescribing Information Page 14 of 19

2 contact your doctor immediately if you suffer the following: sudden or severe stomach pain with other symptoms such as: fever. nausea. vomiting. blood in the stool. low blood pressure (e.g. light-headedness). Do not drive or operate machinery if you suffer: dizziness. blurred vision. 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: Amantadine Anticholinergics (e.g. ipratropium, atropine) Antihistamines (e.g. diphenhydramine, hydroxyzine) Beta-adrenergic agents (e.g. salbutamol) Dopamine antagonists (e.g. metoclopramide) Heart medications (e.g. disopyramide, quinidine) MAO inhibitors (e.g. isocarboxazid) Tricyclic antidepressants (e.g. amitriptyline, doxepin) If you are taking antacids or adsorbent anti-diarrheals, your healthcare professional may tell you to take them at least 1 hour before taking this drug. How to take BUSCOPAN Ampoules: Usual dose (Adults): Administer one-half (10 mg/0.5 ml) to 1 ampoule (20 mg/ml) at an injection rate of 1 ml/min by one of the following routes: intramuscular. subcutaneous. intravenous. No dilution of ampoule is needed. The maximum dose should not exceed 100 mg/day (5 ampoules). What are the possible side effects from using BUSCOPAN Ampoules? This drug may sometimes cause: dry mouth. feeling hot and dried. increased heart rate. not being able to pass urine. increase inside pressure of the eyes. other rare side effects may occur such as: dizziness. flushing. allergic reactions (skin rash, itching). skin reactions (e.g. hives, rash, skin redness, itching). rapid swelling of the skin and skin tissue (angio-edema). decreased blood pressure. 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 including death. Should you have a painful, red eye with loss of vision, seek urgent medical advice. If you experience any of these effects which persist or become troublesome or any side effects not listed here, talk to your healthcare professional. Buscopan Prescribing Information Page 15 of 19

3 Reporting Side Effects You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report: Online at MedEffect ( By calling (toll-free); By completing a Consumer Side Effect Reporting Form and sending it by: - Fax to: (toll-free) or - Mail to: Canada Vigilance Program Health Canada, Postal Locator 0701E Ottawa, Ontario K1A 0K9 NOTE: Contact your healthcare professional if you need more information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. Storage: Protect from light and heat. Store at room temperature (15-30 C). 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 ( or by contacting the sponsor, Boehringer Ingelheim (Canada) Ltd., by visiting or by calling ext (Medical Information). This leaflet was prepared by Boehringer Ingelheim (Canada) Ltd. Last revised: July 27, 2016 Buscopan Prescribing Information Page 16 of 19

4 READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PATIENT MEDICATION INFORMATION Buscopan 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? A spasm is the tightening of muscles in the stomach, intestines, bladder or uterus. This drug is used to relax these muscles and relieve the cramps. How do BUSCOPAN Tablets work? Cramps are caused by sudden, strong tightening of muscles in the stomach and intestines. This drug relaxes the tight muscles and relieves the cramps. What are the ingredients in BUSCOPAN Tablets? Medicinal Ingredient: Hyoscine butylbromide. Non-medicinal Ingredients: Acacia, carnauba wax, castor oil, lactose, magnesium stearate, maize starch, sucrose, polyethylene glycol, shellac, talc, tartaric acid, titanium dioxide and white wax. BUSCOPAN comes in the following dosage forms: Tablets, 10 mg hyoscine butylbromide. Ampoules, 20 mg/ml hyoscine butylbromide. Do not use BUSCOPAN Tablets if you: are allergic to: hyoscine butylbromide. atropinics. 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). problems with urination due to prostate issues. enlarged bowel (megacolon). 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 pregnant or plan to become pregnant, breastfeeding or plan to breastfeed. you should not use this drug if you are pregnant or breastfeeding. are a man and have prostate problems. have stomach acid backing up in your throat (reflux-esophagitis). have inflamed bowels (e.g. ulcerative colitis). were treated in the past for a severe sweating problem. have a fructose (a sugar) or lactose intolerance you should not take this medication. contact your doctor immediately if you suffer the following: sudden or severe stomach pain with other symptoms such as: fever. nausea. vomiting. blood in the stool. low blood pressure (e.g. light-headedness). Buscopan Prescribing Information Page 17 of 19

5 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: Amantadine Anticholinergics (e.g. ipratropium, atropine) Antihistamines (e.g. diphenhydramine, hydroxyzine) Beta-adrenergic agents (e.g. salbutamol) Dopamine antagonists (e.g. metoclopramide) Heart medications (e.g. disopyramide, quinidine) MAO inhibitors (e.g. isocarboxazid) Tricyclic antidepressants (e.g. amitriptyline, doxepin) If you are taking antacids or adsorbent anti-diarrheals, your healthcare professional may tell you to take them at least 1 hour before taking this drug. 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, the 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. Missed Dose: 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 dried. increased heart rate. not being able to pass urine. 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 (angio-edema). 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 help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report: Online at MedEffect ( By calling (toll-free); By completing a Consumer Side Effect Reporting Form and sending it by: - Fax to: (toll-free) or - Mail to: Canada Vigilance Program Health Canada, Postal Locator 0701E Ottawa, Ontario K1A 0K9 Buscopan Prescribing Information Page 18 of 19

6 NOTE: Contact your healthcare professional if you need more information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. Storage: Protect from light and heat. Store at room temperature (15-30 o C). 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 ( or by contacting the sponsor, Boehringer Ingelheim (Canada) Ltd., by visiting or by calling ext (Medical Information). This leaflet was prepared by Boehringer Ingelheim (Canada) Ltd. Last revised: July 27, 2016 Buscopan Prescribing Information Page 19 of 19