BEAMOTIL TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULPHATE

Boleh didapati daripada:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

INN (Nama Antarabangsa):

DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULPHATE

Unit dalam pakej:

1000 Tablets; 100 Tablets

Dikeluarkan oleh:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
BEAMOTIL TABLET
Diphenoxylate Hydrochloride / Atropine Sulfate (2.5mg / 0.025mg)
WHAT IS IN THE LEAFLET
1.
What Beamotil is used for
2.
How Beamotil works
3.
Before you use Beamotil
4.
How to use Beamotil
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Beamotil
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT BEAMOTIL IS USED FOR
This
medicine
is
used
as
adjunctive
therapy
to
treat
symptoms of diarrhoea.
Beamotil may also be used to
reduce
the
frequency
and
fluidity of the stools in people
with colostomies or ileostomies
(part of your bowel removed
causing you to use an external
bag).
HOW BEAMOTIL WORKS
Beamotil
contains
diphenoxylate
hydrochloride
and atropine sulfate along with
other
ingredients.
The
diphenoxylate
reduces
diarrhoea by slowing down the
movements
of
the
intestines.
Because diphenoxylate may be
abused by taking it in doses that
are larger than prescribed, this
causes unpleasant effects. So, a
small
amount
of
atropine
sulfate is included in Beamotil
to discourage abuse.
BEFORE YOU USE BEAMOTIL
-
_When you must not take it _
Do not take this medicine if you:
•
are
allergic
to
diphenoxylate or atropine
or
any
of
the
tablet
ingredients listed at the end
of this leaflet.
•
have
an
allergic
reaction
(you may get a skin rash,
difficulty in breathing, hay
fever or faintness)
•
have
jaundice
(yellowing
of skin and whites of eye)
•
have
diarrhea
caused
by
pseudomembranous colitis
(a
potentially
serious
infection of the gut) which
may occur during or up to
several
weeks
following
antibiotic treatment
•
have inflammatory bowel
disease such as colitis.
•
are breastfeeding
You should use an alternative
form
of
infant
feeding
while
taking Beamotil.
Beamotil
passes
into
breast
milk, so if you take Beamotil
while breastfeeding, your baby
may have some effects from it.
Studies
in
animals
have
not
shown
diphenoxylate
and
atropine
to
be
teratogenic
(disturb
the
development
of
foetus).

Ciri produk

185mm
335mm
WARNING:
Not recommended for chilren under 6 years of age.
BEAMOTIL TABLET
Black 100%
DESCRIPTION
A 5.5 mm diameter, round, convex, white tablet.
_Each tablet contains Diphenoxylate HCI 2.5 mg, Atropine Sulphate 25
mcg._
INDICATIONS
Diphenoxylate and atropine combination is indicated in adults, as an
adjunct to
fluid and electrolyte therapy, in the symptomatic treatment of acute
and chronic
diarrhoea. Beamotil may also be used to reduce the frequency and
fluidity of the
stools in patients with colostomies or ileostomies.
PHARMACODYNAMICS
Diphenoxylate HCI is a synthetic derivative of pethidine with little
or no analgesic
activity. It probably acts both locally and centrally to reduce
intestinal motility.
Atropine is a tertiary amine antimuscarinic alkaloid with both central
and peripher-
al actions. It reduces smooth muscle tone and diminishes gastric and
intestinal
motility but has little effect on gastric secretion. However, in this
preparation,
atropine
is
included
in
doses
below
the
therapeutic
level
in
an
attempt
to prevent abuse by deliberate overdosage.
PHARMACOKINETICS
Diphenoxylate HCI is well absorbed from the gastrointestinal tract. It
is rapidly
and extensively metabolized in the liver principally to diphenoxylic
acid (difenox-
in)
which
has
antidiarrhoeal
activity;
other
metabolites
include
hydroxydiphenoxylic
acid.
It
is
excreted
mainly
as
metabolites
and
their
conjugates in the faeces; less than 10% is excreted in urine. The
half-life of
diphenoxylate is about 2.5 hours while that of diphenoxylic acid is
about 4.5 hours.
It may also be excreted in breast milk.
Atropine is also well absorbed from the gastrointestinal tract. It is
rapidly cleared
from the blood and is distributed throughout the body and crosses the
blood-brain
barrier. It is incompletely metabolised in the liver and about 35%-50%
of a dose is
excreted in the urine as unchanged drug and metabolites. A half-life
of about 2.5
hours has been reported. Atropine crosses the placenta and traces
appear in milk.
The onset of actio