HYOSCINE BUTYLBROMIDE

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hyoscine butylbromide, Quantity: 20 mg

Available from:

AFT Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: hydrochloric acid; water for injections; sodium chloride

Administration route:

Intramuscular, Intravenous

Units in package:

5 ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Spasm of the gastrointestinal tract, biliary spasm, renal spasm, diagnostic aid in radiology.

Product summary:

Visual Identification: A clear and colorless solution; Container Type: Ampoule; Container Material: Glass; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-11-17

Patient Information leaflet

HYOSCINE BUTYLBROMIDE - AFT
1
HYOSCINE BUTYLBROMIDE - AFT AMPOULES
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 HYOSCINE BUTYLBROMIDE - AFT?
HYOSCINE BUTYLBROMIDE - AFT contains the active ingredient hyoscine
butylbromide. Hyoscine butylbromide is an
anticholinergic medicine. HYOSCINE BUTYLBROMIDE - AFT 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 using HYOSCINE
BUTYLBROMIDE - AFT? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE HYOSCINE BUTYLBROMIDE - AFT?
Do not use if you have ever had an allergic reaction to HYOSCINE
BUTYLBROMIDE - AFT 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 use
HYOSCINE BUTYLBROMIDE - AFT? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with HYOSCINE BUTYLBROMIDE - AFT and
affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I RECEIVE HYOSCINE BUTYLBROMIDE - AFT?
•
Your doctor will decide what dose you will receive and the duration of
treatment.
•
HYOSCINE BUTYLBROMIDE - AFT 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 use HYOSCINE
BUTYLBROMIDE - AFT? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING HYOSCINE BUTYLBROMIDE - AFT?
THINGS YOU
SHOULD DO
•
Call your doctor straight away if the pain is severe or does not
improve within 48

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
HYOSCINE BUTYLBROMIDE – AFT
(HYOSCINE BUTYLBROMIDE)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Hyoscine butylbromide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
HYOSCINE BUTYLBROMIDE – AFT hyoscine butylbromide 20 mg/1mL contains
20 mg
hyoscine butylbromide per 1 mL ampoule.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
HYOSCINE BUTYLBROMIDE – AFT hyoscine butylbromide 20 mg/1mL is a
clear and
colourless solution for injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Spasm
of
the
gastrointestinal
tract,
biliary
spasm,
renal
spasm,
diagnostic
aid
in
radiology.
4.2
DOSE AND METHOD OF ADMINISTRATION
1 or 2 ampoules (20 or 40 mg) by intramuscular or slow intravenous
injection. A
maximum daily dose of 100 mg should not be exceeded.
HYOSCINE BUTYLBROMIDE – AFT injection should not be administered on
a continuous
daily basis or for extended periods without investigating the cause of
abdominal pain.
Product is for single use in one patient only. Discard any residue.
4.3
CONTRAINDICATIONS
HYOSCINE BUTYLBROMIDE – AFT is 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
•
prostatic hypertrophy with urinary retention
e006139 Hyoscine butylbromide - AFT
Product information - clean
1.3.1.1 Pg. 1
2
•
myasthenia gravis
•
glaucoma
•
pathological tachyarrhythmias
•
megacolon
Hyoscine butylbromide should not be given to patients with porphyria
as, according to a
single report, it has been said to exacerbate the disease.
By
intramuscular
injection,
HYOSCINE
BUTYLBROMIDE
–
AFT
injections
are
contraindicated in patients being treated with anticoagulant drugs as
intramuscular
haematoma may occur. In these patients, intravenous routes may be
used.
4.4
SPECIAL WARNING