HYOSCINE BUTYLBROMIDE SXP hyoscine butylbromide 20 mg/1 mL solution for injection ampoules

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hyoscine butylbromide, Quantity: 20 mg

Available from:

Southern XP IP Pty Ltd

INN (International Name):

Hyoscine butylbromide

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous, Intramuscular

Units in package:

10, 5

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: Clear, colourless or almost colourless solution filled in Type I clear glass ampoules.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-07-12

Patient Information leaflet

HYOSCINE BUTYLBROMIDE SXP
Hyoscine Butylbromide SXP
1
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
1. WHY AM I GIVEN HYOSCINE BUTYLBROMIDE SXP?
2. WHAT SHOULD I KNOW BEFORE I RECEIVE HYOSCINE BUTYLBROMIDE SXP?
3. WHAT IF I AM TAKING OTHER MEDICINES?
4. HOW DO I RECEIVE HYOSCINE BUTYLBROMIDE SXP?
5. WHAT SHOULD I KNOW AFTER BEING GIVEN HYOSCINE BUTYLBROMIDE SXP?
6. ARE THERE ANY SIDE EFFECTS?
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
HYOSCINE BUTYLBROMIDE SXP CONTAINS THE ACTIVE INGREDIENT HYOSCINE
BUTYLBROMIDE. Hyoscine butylbromide is an
anticholinergic medicine. HYOSCINE BUTYLBROMIDE SXP 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 Hyoscine
Butylbromide SXP? in the full CMI.
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 Hyoscine Butylbromide SXP? in the full CMI.
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. Hyoscine
Butylbromide SXP 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.
•
Your doctor will decide what dose you will receive and the duration of
treatment.
•
Hyoscine Butylbromide SXP 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

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – HYOSCINE BUTYLBROMIDE
SXP (HYOSCINE BUTYLBROMIDE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Hyoscine butylbromide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ampoule containing hyoscine butylbromide 20 mg in 1 mL.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Clear, colourless or almost colourless solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Spasm of the gastrointestinal tract, biliary spasm, renal spasm,
diagnostic aid in radiology.
4.2
D
OSE 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 ampoules 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
C
ONTRAINDICATIONS
Hyoscine butylbromide is contraindicated in patients with:
•
known hypersensitivity to hyoscine butylbromide or to any excipients
of the product
(excipients are listed under section 6.1 List of excipients)
•
mechanical stenoses of the gastrointestinal tract
•
achalasia
•
paralytic or obstructive ileus
•
intestinal atony
•
prostatic hypertrophy with urinary retention
•
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.
2
By intramuscular injection, hyoscine butylbromide ampoules are
contraindicated in patients being
treated with anticoagulant drugs as intramuscular haematoma may occur.
In these patients,
intravenous routes may be used.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
In case severe, unexplained abdominal pain persists or worsens, or
occurs together with symptoms
like fever, nausea, vomiting, changes in bowel movements, abdominal
tenderness, decreased blood
pressure, fain