Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
hyoscine butylbromide, Quantity: 20 mg/mL
Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare
Hyoscine butylbromide
Injection, solution
Excipient Ingredients: sodium chloride; water for injections
Intravenous, Intramuscular
5 x 1mL
Medicine Registered
(S4) Prescription Only Medicine
Spasm of the gastrointestinal tract, biliary spasm, renal spasm, diagnostic aid in radiology.
Visual Identification: Colourless clear solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1991-09-26
BUSCOPAN ® AMPOULES B u s c o p a n ® A m p o u l e s 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. For more information, see Section 1. Why am I given Buscopan? in the full CMI. 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. For more information, see Section 2. What should I know before I receive Buscopan? in the full CMI. 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. For more information see Section 3. What if I am taking or using other medicines? in the full CMI. 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. More instructions can be found in Section 4. How do I receive Buscopan? in the full CMI. 5. WHAT SHOULD I KNOW AFTER BEING GIVEN BUSCOPAN? THINGS YOU SHOULD DO • Call your doctor straight away if the pain is severe or does not improve withi Read the complete document
bus-ccdsv1-piv2-22sep20 Page 1 of 10 AUSTRALIAN PRODUCT INFORMATION– BUSCOPAN ® AND BUSCOPAN ® FORTE (HYOSCINE BUTYLBROMIDE) 1 NAME OF THE MEDICINE HYOSCINE BUTYLBROMIDE 2 QUALITATIVE AND QUANTITATIVE COMPOSITION BUSCOPAN ® tablets contain 10 mg hyoscine butylbromide per tablet. Excipients of known effect: sucrose. BUSCOPAN ® FORTE tablets contain 20 mg hyoscine butylbromide per tablet. Excipients of known effect: lactose monohydrate. BUSCOPAN ® ampoules contain 20 mg/1 mL hyoscine butylbromide per ampoule. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM BUSCOPAN ® tablets: Round, white, biconvex sugar coated tablet. BUSCOPAN ® FORTE tablets: White round biconvex film-coated tablets. One side is marked "20", other side is marked "B". BUSCOPAN ® ampoules: Colourless clear solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BUSCOPAN ® AND BUSCOPAN ® FORTE TABLETS Spasm of the gastrointestinal tract. BUSCOPAN ® AMPOULES Spasm of the gastrointestinal tract, biliary spasm, renal spasm, diagnostic aid in radiology. bus-ccdsv1-piv2-22sep20 Page 2 of 10 4.2 DOSE AND METHOD OF ADMINISTRATION TABLETS Adults and children over 6 years: 2 BUSCOPAN ® tablets (2 x 10mg) four times daily. OR 1 BUSCOPAN ® FORTE tablet (1 x 20 mg) four times daily. BUSCOPAN ® tablets are not recommended for children under 6 years of age. AMPOULES 1 or 2 ampoules (20 or 40mg) by intramuscular or slow intravenous injection. A maximum daily dose of 100mg should not be exceeded. BUSCOPAN ® tablets and ampoules should not be taken on a continuous daily basis or for extended periods without investigating the cause of abdominal pain. 4.3 CONTRAINDICATIONS BUSCOPAN ® are contraindicated in patients with: • known hypersensitivity to hyoscine butylbromide or to any of the excipients of the product (excipients are listed under Section 6.1 List of excipients) • mechanical stenosis in the gastrointestinal tract • achalasia • paralytic or obstructive ileus • intestinal atony • pro Read the complete document