LOMIDE CAPSULE 2MG

Land: Malaysia

Språk: engelsk

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

Aktiv ingrediens:

LOPERAMIDE HYDROCHLORIDE

Tilgjengelig fra:

SPG PHARMA (MALAYSIA) SDN BHD

INN (International Name):

LOPERAMIDE HYDROCHLORIDE

Enheter i pakken:

10 blister packs x 10 Capsules

Produsert av:

SIAM BHEASACH CO LTD

Informasjon til brukeren

_ _
_ _
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_ Consumer Medication Information Leaflet (RiMUP)_
LOMIDE CAPSULE
Loperamide Hydrochloride (2mg)
1
WHAT IS IN THIS LEAFLET
1.
What LOMIDE is used for
2.
How LOMIDE works
3.
Before you use LOMIDE
4.
How to use LOMIDE
5.
While you are using LOMIDE
6.
Side effects
7.
Storage and Disposal of
LOMIDE
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT LOMIDE IS USED FOR
LOMIDE is used for diarrhoea.
You may also be given LOMIDE to
reduce the number and volume of
stools when you have part of your
intestines removed, as this often
causes diarrhoea.
HOW LOMIDE WORKS
LOMIDE makes the stools more
solid and less frequent by reducing
the intestinal muscles movement
and increase the time for food to
remain in the gastrointestinal tract.
BEFORE YOU USE LOMIDE
_When you must not use it _
Do not use LOMIDE if you:
▪
are allergic to loperamide
hydrochloride, or any other
ingredients listed in this leaflet
▪
have a high body temperature or
there is blood in the stools
▪
have an inflammation of the
small and/or large intestine
▪
have a condition where slowing
of the intestine movement should
be avoided, for example, if you
are constipated or your abdomen
is swollen
_Pregnancy and Lactation _
If you are, or think you may be
pregnant, inform your doctor, who
will decide if you can take
LOMIDE.
_Before you start to use it _
▪
Tell your doctor if you have
allergies to any medicines, foods,
preservatives or dyes
▪
Appropriate fluid and electrolyte
should be taken to protect against
dehydration in all cases of
diarrhoea especially children
▪
If no improvement within 48
hours for an acute diarrhoea or if
you suffer from liver impairment,
do not take any more capsules
and consult your doctor
_Taking other medicines _
Tell your doctor or pharmacist if
you are taking any medicine,
including traditional products
bought without a prescription, or if
you are taking any of the following:
▪
Ritonavir (to treat human
immunodeficiency virus (HIV))
▪
Quinidin

Preparatomtale

PRODUCT NAME
Lomide Capsule 2 mg
NAME AND STRENGTH OF ACTIVE SUBSTANCE
Each capsule contains 2 mg Loperamide HCl
PRODUCT DESCRIPTION
White granule in light green-dark green capsule shell No.4 with
“
” on both of capsule shell
PHARMACODYNAMICS
Pharmacotherapeutic group: 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.
PHARMACOKINETICS
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
capsules, coated and uncoated tablets, chewable and orodispersible
table, oral solution) are bioequivalent in terms of rate and extent of
loperamide absorption.
Distribution
The plasma protein binding of loperamide is 95%, mainly to albumin.
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 through CYP3A4 and CYP2C8. Due
to this remarkably high first pass effect, plasma concentrations of
unchanged drug remain extremely low.
Excretion
The half-life of loperamide is about 11 hours with a range of 9-14
hours. Excretion of the unchanged loperamide and the metabolites
mainly occurs through the faeces.
Pediatric population
No pharmacokinetic studies were performed in pediatric population.
It is expected that pharmacokinetic behavior of loperamide will be
similar to those in adults.
INDICATION
Use for the control and symptomatic relief of acute and chronic
diarrhea. In patients with an ileostomy it can be used to reduce the
number and volume of stools and to harden their consistency.
DOSAGE AND ADMINISTRATION
Adults and Paediatr