Buscopan Tablet 10mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

HYOSCINE BUTYLBROMIDE

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

HYOSCINE BUTYLBROMIDE

Unit dalam pakej:

20 Tablet Tablets; 100 Tablet Tablets

Dikeluarkan oleh:

Delpharm Reims

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
BUSCOPAN
_® _
TABLET
Hyoscine butylbromide (10 mg)
WHAT IS IN THIS LEAFLET
1.
What Buscopan
®
is used for
2.
How Buscopan
®
works
3.
Before you use Buscopan
®
4.
How to use Buscopan
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Buscopan
®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT BUSCOPAN
®
IS USED FOR
Buscopan
®
are used to relieve cramps
in the muscles of your:
•
Stomach
•
Gut (intestine)
•
Bladder and the tubes that lead to the
outside of your body (urinary system)
HOW BUSCOPAN
®
WORKS
Buscopan
®
contain a medicine called
“Hyoscine-N-butylbromide”. This
belongs to a group of medicines called
“antispasmodics”.
Hyoscine works by relaxing the muscle
found in the walls of the stomach, and
bowel. This type of muscle is called
smooth muscle or involuntary muscle.
It normally contracts and relaxes
without our conscious control and we
are not normally aware of it. However,
if the muscles go into spasm, this can
cause pain.
Hyoscine stops the spasms in the
smooth muscle, allowing it to relax.
This reduces the painful spasms and
cramps.
BEFORE YOU USE BUSCOPAN
®
_-When you must not use it _
Do not take Buscopan
®
if:
•
You are allergic (hypersensitive) to
hyoscine butylbromide or any of the
other ingredients (listed in Product
Description)
•
You have something called
‘myasthenia gravis’ (a very rare muscle
weakness problem).
•
You have a very enlarged bowel
(megacolon).
If you are not sure, talk to your doctor
or pharmacist before taking this
medicine.
_-Before you start to use it _
Take special care with Buscopan
®
Check with your doctor or pharmacist
before taking your medicine if:
•
You have a very fast heart rate or
other heart problems
•
You have glaucoma (an eye problem)
•
You have difficulty or pain passing
water (urine) such as men with prostate
problems
•
You have a suspected or confirmed
blockage of the bowel (symptoms
include severe a

Ciri produk

0057-07 20180129
B uscopan ®
Composition
1 sugar- coated tablet contains 10 mg hyoscine -N -b utylbromide
Description
Round, white, biconvex, sugar -coated tablets
Properties
Buscopan
® exerts a spasmolytic action on the smooth muscle of the gastro- intestinal, biliary and genito-urinary tracts. As a
quaternary ammonium derivative, hyoscine- N-butylbromide does not enter the central nervous system. Therefore,
anticholinergic side effects at the central nervous system do not occur. Peripheral anticholinergic action results f rom a ganglion-
blocking action within the visceral wall as well as from an anti -muscarinic activity.
Pharmacokinetics
Absorption As a quaternary ammonium compound, hyoscine- N-butylbromide is highly polar and hence only partially absorbed following
oral (8%) or rectal (3%) administration
. After oral administration of single doses of hyoscine butylbromide in the range of 20 to
400 mg, mean peak plasma concentrations between 0.11 ng/mL and 2.04 ng/mL were found at approximately 2 hours . In the
same dose range, the observed mean AUC
0 -tz-values varied from 0.37 to 10.7 ng h/mL . The median absolute bioavailabilities of
different dosage forms, i.e. coated tablets, suppositoires and oral solution, containing 100 mg of hyoscine butylbromide each
were found to be l ess than 1%.
Distribution Because of its high affinity for muscarinic recept ors and nicotinic receptors, hyoscine butylbromide is mainly distributed on
muscle cells of the abdominal and pelvic area as well as in the intramural ganglia of the abdominal organs . Protein binding in
the human plasma occurs at 8- 13% and in a 4.4% human serum albumin solution at 3- 11%. Animal studies demonstrate that
hyoscine butylbromide does not pass the blood- brain barrier, but no clinical data to this eff ect is available. Hyoscine
butylbromide (1 mM) has been observed to interact with the choline transport (1.4 nM) in epithelial cells of human placenta in
vitro .
Metabolism and elimination Following oral administration of single doses in the rang