BUSCOPAN hyoscine butylbromide 10mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
28-12-2020
Summary of Product characteristics
(SPC)
28-12-2020
Public Assessment Report
(PAR)
01-12-2017
Active ingredient:
hyoscine butylbromide, Quantity: 10 mg
Available from:
Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare
INN (International Name):
Hyoscine butylbromide
Pharmaceutical form:
Tablet, sugar coated
Composition:
Excipient Ingredients: colloidal anhydrous silica; Acacia; white beeswax; calcium hydrogen phosphate dihydrate; stearic acid; maize starch; macrogol 6000; tartaric acid; purified talc; sucrose; povidone; Carnauba Wax; titanium dioxide; soluble maize starch
Administration route:
Oral
Units in package:
10, 100, 20
Prescription type:
(S2) Pharmacy Medicine, (S4) Prescription Only Medicine
Therapeutic indications:
Spasm of the gastrointestinal tract
Product summary:
Visual Identification: Round, white, biconvex sugar coated tablet.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Registered
Authorization date:
1994-08-03
Patient Information leaflet
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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?
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.
For more information, see Section 1. Why am I taking Buscopan? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE 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 take
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.
For more information see Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE BUSCOPAN?
The recommended dose for adults and children over 6 years of age is
two tablets 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.
More instructions can be found in Section 4. How do I take Buscopan?
in the full CMI.
5.
WHAT SHOULD I KNOW AFTER TAKING BUSCOPAN?
THINGS YOU
SHOULD DO
•
Call your doctor straight away if the pain is severe or does not
improve within 48 hours of taking
Buscopan.
•
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.
THINGS YOU
SHOULD NOT DO
•
Do not drink alcohol after taking
Read the complete document
Summary of Product characteristics
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
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