Buscopan Forte

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Hyoscine butylbromide 20mg

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Hyoscine butylbromide 20 mg

Dosage:

20 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Hyoscine butylbromide 20mg Excipient: Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry white 85G18490 Povidone Purified water

Prescription type:

Restricted

Manufactured by:

Boehringer Ingelheim Pharma GmbH & Co KG

Therapeutic indications:

For the treatment of muscle spasm of the gastrointestinal tract Relief of acute stomach ache and pain due to cramps and spasms (as stated on label)

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Al - 10 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2015-02-26

Patient Information leaflet

1
BUSCOPAN

FORTE
TABLETS
_Hyoscine butylbromide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common
questions about
Buscopan Forte
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
(Australia)
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
Forte 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 FORTE
IS USED FOR
Buscopan Forte is known as an
anticholinergic medicine. It
relieves
the pain of stomach and
bowel
cramps by helping your
digestive
system to relax.
Buscopan Forte in packs of 10
tablets
can be bought from a
pharmacy
without a doctor’s
prescription.
Buscopan Forte tablets are
intended
for the treatment of
temporary
complaints.
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 FORTE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE BUSCOPAN FORTE 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 BUSCOPAN FORTE IF
YOU
HAVE ANY CONDITIONS OF
GALACTOSE
INTOLERANCE (FOR
EXAMPLE,
GALACTOSAEMIA, THE
LAPP LACTASE
DEF

Summary of Product characteristics

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