SW HYOSCINE BUTYLBROMIDE TABLET 10MG

Country: Malaysia

Language: English

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

Active ingredient:

HYOSCINE BUTYLBROMIDE

Available from:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (International Name):

HYOSCINE BUTYLBROMIDE

Units in package:

500 Tablet Tablets; 1000 Tablet Tablets; 100 Tablet Tablets; 1000 Tablets

Manufactured by:

SUNWARD PHARMACEUTICAL SDN. BHD.

Patient Information leaflet

SW HYOSCINE BUTYLBROMIDE TABLET
Hyoscine Butylbromide (10mg)
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1. What SW Hyoscine Butylbromide Tablet
is used for
2. How SW Hyoscine Butylbromide Tablet
works
3. Before you use SW Hyoscine Butylbromide
Tablet
4. How to use SW Hyoscine Butylbromide
Tablet
5. While you are using it
6. Side effects
7. Storage and disposal of SW Hyoscine
Butylbromide Tablet
8. Product description
9. Manufacturer and Product Registration
Holder
10.Date of revision
WHAT SW HYOSCINE BUTYLBROMIDE TABLET
IS USED FOR
It
is
used
for
relief
spasm
and
increased
movement
of
gastrointestinal,
gall
bladder
and urinary tract. It also used to relaxes the
lower part of the uterus and relieve painful
menstruation.
HOW SW HYOSCINE BUTYLBROMIDE TABLET
WORKS
The
active
ingredient
in
the
medicine
is
hyoscine butylbromide. It helps reduces the
movement
and
tone
of
the
gastrointestinal
tract and may even reduce the volume of its
various secretions.
BEFORE YOU USE SW HYOSCINE BUTYLBROMIDE
TABLET
_- When you must not use it _
Do not take this medicine if you:-

are allergic to hyoscine butylbromide or any
other ingredients of this medicine (listed in
Product Description).

have
increased
pressure
in
the
eye,
esophagus (food tube) movement disorder,
prostate enlargement or obstruction of the
bladder neck.

have muscle weakness.
_- Before you start to use it _
You should check with your doctor if you :-

have gastric outlet obstruction.

are elderly person.

have metabolic, kidney or liver problem.

are pregnant, planning for pregnancy or
breast-feeding before using any medicine.
_ _
_ _
_ _
_ _
_ _
_- Taking other medicines _
There are few medicines which may interact
with SW Hyoscine Butylbromide Tablet. Tell
your
doctor
if
you
are
taking
any
other
medicines, including any that you buy without
a prescription from a pharmacy, supermarket
or health food shop.
You should talk to your doctor or pharmacist
if you are taking on the following medicines:-

Tricyclic

Summary of Product characteristics

HYOSCINE BUTYLBROMIDE TABLET 10MG
Each tablet contains:
Hyoscine N-Butylbromide 10mg
PHARMACOLOGY:
The effect of Hyoscine on the heart is to alter rate. With small
doses, the heart rate decreases
temporarily
and
increases
with
larger
doses.
It
also
reduces
the
motility
and
tone
of
the
gastrointestinal tract and may even reduce the volume of its various
secretions.
The
drug
will
produce
mydriasis
and
paralysis
of
accommodation
(cyclopegia).
Hyoscine
butylbromide is poorly absorbed from the gastrointestinal tract. In 10
experiments in 3 volunteers,
hyoscine butylbromide in single doses of up to 600mg taken as tablet,
appeared to be inactive by mouth,
either it remained unabsorbed or it was absorbed more slowly than it
was inactivated in the body. After
50 to 100mg of hyoscine butylbromide was given to 6 male volunteers,
by mouth or by intra-intestinal
infusion, very little hyoscine butylbromide was absorbed from the
upper small intestine and none
appeared in the plasma. About 2% and 90% of the dose appeared in the
urine and faeces respectively.
After intravenous administration of 8mg to 1 volunteer, 42% was
eliminated in the urine and 37% in
faeces.
INDICATIONS:
It is indicated for gastrointestinal spasm hypermotility, biliary
dyskinesia and spasm of the urinary
tract, delayed relaxation of the lower uterine segment and
dysmenorrhea.
DOSAGE:
Route of administration : Oral
Adults : One to two tablets, three to four times daily.
Children (6-12 years) : One tablet three times daily.
CONTRAINDICATIONS:
Because of the anti-cholinergic effect of hyoscine, it should be not
used in patients with glaucoma,
achalasia, prostactic hypertrophy, or obstruction of the bladder neck.
It is also contraindicated in
patients with myasthenia gravis and in patients known to be
hypersensitive to hyoscine.
PRECAUTIONS:
Potentially alarming idiosyncratic reactions may occur with ordinary
therapeutic doses of hyoscine
butylbromide. Hyoscine should be used with caution in patients with
pyloric obstruction, or urinary
bladder neck obstruction