IMODIUM CAPSULE 2MG

Land: Malaysia

Språk: engelsk

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

Aktiv ingrediens:

LOPERAMIDE HYDROCHLORIDE

Tilgjengelig fra:

JOHNSON & JOHNSON SDN BHD

INN (International Name):

LOPERAMIDE HYDROCHLORIDE

Enheter i pakken:

240Capsule Capsules

Produsert av:

JNTL CONSUMER HEALTH (FRANCE) SAS

Informasjon til brukeren

IMODIUM CAPSULE
®
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
Loperamide Hydrochloride (2mg)
WHAT IS IN THIS LEAFLET
1.
What IMODIUM
®
is used for
2.
How IMODIUM
®
works
3.
Before you use IMODIUM
®
4.
How to use IMODIUM
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of IMODIUM
®
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
WHAT IMODIUM
® IS USED FOR
IMODIUM
®
is used for diarrhoea. You
may also be given IMODIUM
®
to reduce
the number and volume of stools when
you have part of your intestines removed,
as this often causes diarrhoea.
HOW IMODIUM
® WORKS
IMODIUM
®
makes the stools more solid
and less frequent by reducing the intestinal
muscles movement and increase the time
for food to remain in the gastro-intestinal
tract.
BEFORE YOU USE IMODIUM
®
-
_When you must not use it _
•
If there is blood in the stools or you have
a high body temperature.
•
If you have an inflammation of the small
and/or large intestine.
•
If your doctor has told you that you have
a
condition
where
slowing
of
the
intestine movement should be avoided,
for example, if you are constipated or
your abdomen is swollen.
•
If
you
know
you
are
hypersensitive
(allergic) to loperamide hydrochloride or
one of the other ingredients.
•
Not recommended for children under 6
years of age.
_Pregnancy and lactation _
If you are, or think you may be pregnant,
you should inform your doctor, who will
decide if you can take IMODIUM
®
.
-
_Before you start use it _
•
Tell your doctor if you have allergies to
any
other
medicines,
foods,
preservatives, or dyes.
•
Appropriate fluid and electrolyte therapy
should be taken to protect against
dehydration
in
all
cases
of diarrhoea
especially children.
•
If
no improvement within 48 hours for
an acute diarrhea or if you suffer from
liver impairment, do not take any more
capsules and consult your doctor.
-
_Taking other medicines _
In
particular,
tell
your
doctor
or
pharmacist if you are taking any of the
following:
•

Preparatomtale

IMODIUM hard capsules, 13 June 2016 January 2023,
Based on CCDS Version 10 dated 13 June 2016 CCDS V13;23 Aug 2021CCDS
V13; 23 Aug 2021, UK SmPC rev 19
April 2022
1
DESCRIPTION
Imodium
®
contains the synthetic antidiarrhoeal for oral use, Loperamide HCl.
Imodium
®
is available in capsules. Each capsule contains 2mg Loperamide HCl.
PHARMACEUTICAL FORM
White powder filled in capsules with green cap and dark grey body
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: A07 DA03
Antipropulsives
Loperamide binds to the opiate receptor in the gut wall. Consequently,
it inhibits the
release of acetylcholine and prostaglandins, thereby reducing
propulsive peristalsis, and
increasing intestinal transit time. Loperamide increases the tone of
the anal sphincter,
thereby reducing incontinence and urgency.
PHARMACOKINETIC PROPERTIES
Absorption: Most ingested loperamide is absorbed from the gut, but as
a result of
significant first pass metabolism, systemic bioavailability is only
approximately 0.3%.
Loperamide
HCl
formulations (hard
and
soft
capsule,
coated
and
uncoated
tablet,
chewable and orodispersable tablet, oral solution) are bioequivalent
in terms of rate and
extent of loperamide absorption.
Distribution: Studies on distribution in rats show a high affinity for
the gut wall with a
preference for binding to receptors of the longitudinal muscle layer.
The plasma protein
binding of loperamide is 95%, mainly to albumin. Non-clinical data
have shown that
loperamide is a P-glycoprotein substrate.
Metabolism:
Loperamide
is
almost
completely
extracted
by
the
liver,
where
it
is
predominantly
metabolized,
conjugated
and
excreted
via
the
bile.
Oxidative
N-demethylation is the main metabolic pathway for loperamide, and is
mediated mainly
through
CYP3A4
and
CYP2C8.
Due
to
this
very
high
first
pass
effect,
plasma
concentrations of unchanged drug remain extremely low.
Excretion: The half-life of loperamide in man is about 11 hours with a
range of
9-14 hours. Excretion of the unchanged loperamide and the metabolites
mainly occurs