Buscopan

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Hyoscine butylbromide 20 mg/mL

Tersedia dari:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Nama Internasional):

Hyoscine butylbromide 20 mg/mL

Dosis:

20 mg/mL

Bentuk farmasi:

Solution for injection

Komposisi:

Active: Hyoscine butylbromide 20 mg/mL Excipient: Sodium chloride Water for injection

Unit dalam paket:

Ampoule, 1ml, 5 dose units

Kelas:

Prescription

Jenis Resep:

Prescription

Diproduksi oleh:

Boehringer Ingelheim Pharma GmbH & Co KG

Ringkasan produk:

Package - Contents - Shelf Life: Ampoule, 1ml - 5 dose units - 36 months from date of manufacture stored at or below 30°C

Tanggal Otorisasi:

1969-12-31

Selebaran informasi

1
BUSCOPAN
 TABLETS
_Hyoscine butylbromide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Buscopan tablets.
It does not contain all available
information. It does not take the
place of talking to your doctor or
pharmacist.
This leaflet was last updated on the
date at the end of this leaflet. More
recent information may be
available. The latest Consumer
Medicine Information is available
from your pharmacist, doctor, or
from www.medicines.org.au and
www.medsafe.govt.nz/Consumers/c
mi/CMIForm.asp (New Zealand)
and may contain important
information about the medicine and
its use of which you should be
aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Buscopan
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS INFORMATION WITH THE
MEDICINE.
You may need to read it again.
WHAT BUSCOPAN IS
USED FOR
Buscopan is known as an
anticholinergic medicine. It relieves
the pain of stomach and bowel
cramps by helping your digestive
system to relax.
Buscopan blister packs of 20 tablets
are available only at a pharmacy.
Buscopan blister packs of 100
tablets are available only with a
doctor's prescription.
ALWAYS CONSULT YOUR DOCTOR OR
PHARMACIST IF THE PAIN DOES NOT
IMPROVE WITHIN 48 HOURS OR IF
PAIN WORSENS AFTER TREATMENT.
BEFORE YOU TAKE
BUSCOPAN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE BUSCOPAN IF YOU ARE
ALLERGIC TO HYOSCINE BUTYLBROMIDE
OR TO ANY OF THE OTHER INGREDIENTS
LISTED AT THE END OF THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the
skin.
DO NOT TAKE THIS MEDICINE IF YOU
HAVE FRUCTOSE INTOLERANCE.
Buscopan contains sucrose as an
ingredient.
DO NOT TAKE BUSCOPAN IF YOU
HAVE:
•
myasthenia gravis - a condition
in which the muscles become
wea

Karakteristik produk

buscopan-ccdsv1-dsv7-d1-14nov22
Page 1
DATA SHEET
1
BUSCOPAN AND BUSCOPAN FORTE
BUSCOPAN® 10 mg tablet and 20 mg/ml injection
BUSCOPAN® FORTE 20 mg film coated tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hyoscine-N-butylbromide 10 mg tablet, 20 mg film coated tablet and 20
mg/ml injection
Excipient with known effect: Lactose*
*Only applicable for the product BUSCOPAN® FORTE 20 mg film coated
tablet.
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Tablet 10 mg: white, unmarked, biconvex, sugar-coated.
Tablet 20 mg: white, round, biconvex, film coated tablets embossed
with the letter ‘B’ on one side
and the number ‘20’ on the other side.
Injection 20 mg/ml: clear, colourless solution in glass ampoules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Muscle spasm of the gastrointestinal tract.
4.2
DOSE AND METHOD OF ADMINISTRATION
ORAL:
Adults and children over 6 years:
2 BUSCOPAN 10 mg tablets (20 mg) four times a day
or
1 BUSCOPAN FORTE 20 mg tablet four times a day.
buscopan-ccdsv1-dsv7-d1-14nov22
Page 2
The tablets should be swallowed whole with adequate fluid.
PARENTERAL:
Adults and adolescents over 12 years 1 or 2 ampoules (20 – 40 mg)
may be administered by slow
intravenous, intramuscular or subcutaneous injection several
times a day. A maximum daily dose of 100mg should not be
exceeded.
Infants and young children:
In severe cases, 0.3 - 0.6 mg/kg bodyweight, to be
administered by slow intravenous, intramuscular or
subcutaneous injection several times a day.The maximum
daily dose of 1.2 mg/kg should not be exceeded.
BUSCOPAN and BUSCOPAN FORTE should not be taken on a continuous daily
basis or for
extended periods without investigating the cause of abdominal pain.
4.3
CONTRAINDICATIONS
BUSCOPAN and BUSCOPAN FORTE are contraindicated in myasthenia gravis,
mechanical
stenosis in the gastrointestinal tract, paralytical or obstructive
ileus, megacolon and in patients who
have demonstrated prior hypersensitivity to hyoscine butylbromide or
any other component of the
pr