COLODIUM CAPSULE 2MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LOPERAMIDE HYDROCHLORIDE

Boleh didapati daripada:

HOVID BERHAD

INN (Nama Antarabangsa):

LOPERAMIDE HYDROCHLORIDE

Unit dalam pakej:

100Capsule Capsules; 500 Capsules

Dikeluarkan oleh:

HOVID BERHAD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
COLODIUM 2MG CAPSULE
LOPERAMIDE HCL (2 MG)
1
WHAT IS IN THIS LEAFLET
1.
What Colodium is used for
2.
How Colodium works
3.
Before you use Colodium
4.
How to use Colodium
5.
While you are using Colodium
6.
Side effects
7.
Storage and Disposal of Colodium
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
WHAT COLODIUM IS USED FOR
Colodium is used to treat sudden (acute)
diarrhoea
or
long-lasting
(chronic)
diarrhoea.
Colodium is also used in patients who
have
had
part
of
their
intestines
removed
by
surgery
(intestinal
resection).
HOW COLODIUM WORKS
This medicine belongs to a group of
medicines called ’antidiarrhoeals’ which
are used to treat diarrhea.
BEFORE YOU USE COLODIUM
_- When you must not use it _
_ _
Do not take this medicine if:

you
are
hypersensitive
to
loperamide
or
any
of
the
other
ingredients of this product .

you
have
severe
diarrhoea
with
blood in the stools or fever

you have inflammation of the lower
bowels

you
are
constipated,
or
have
to
avoid becoming constipated

you are breast-feeding
Do not give Colodium to children under
the age of 12 years.
_- Before you start to use it_
_ _
Tell your doctor if:

you
are
allergic
to
any
other
medicines,
foods,
dyes
or
preservatives.

have or have ever had liver disease

have kidney disease

have
AIDS
(Acquired
Immune
Deficiency Syndrome)

have
glaucoma
(high
pressure
in
the eye)

have bladder problems

you are pregnant or plan to become
pregnant

you are breastfeeding or
wish
to
breastfeed

you plan to have surgery

regularly drink a lot of alcohol.
_- Taking other medicines _
_ _
Talk to your doctor or pharmacist if you
are taking any other medicines in any
form
including
any
that
you
buy
or
obtained without a prescription.
Some
medicines
interfere
with
Colodium.
They include:

sleeping
tablets
or
medicines
to
treat anxiety and nervousness

medicines to treat depression

medicines
that
slow
down
the
action

Ciri produk

COLODIUM
VICOL14-var (MY)
DESCRIPTION
Green opaque and grey opaque capsule with “HD” printed
on one end and “CD 2” on the other end of the capsule.
COMPOSITION
Loperamide Hydrochloride 2 mg per capsule.
PHARMACODYNAMICS
Loperamide is a synthetic derivative of pethidine that inhibits
gut motility and may also reduce gastrointestinal secretions.
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
viscosity, increases bulk density, reduces daily fecal volume,
and diminishes loss of fluids and electrolytes. Loperamide
increases the tone of the anal sphincter, thereby reducing
incontinence and urgency. Additionally, loperamide will prolong
mouth-to-cecum transit time without affecting gastric emptying.
Loperamide has an antidiarrhoeal effect. It slows gastro-
intestinal motility by effects on the circular and longitudinal
muscles of the intestine. It binds to opioid receptors in brain
homogenates and intestinal strips. Its constipating action is
probably due, at least in part, to actions at these receptors.
PHARMACOKINETICS
ABSORPTION
Loperamide is not well absorbed from the gastrointestinal
tract. Most ingested loperamide is absorbed from the gut, but
as
result
of
significant
first
pass
metabolism,
systemic
bioavailability is only approximately 0.3%.
BLOOD CONCENTRATION
Concentrations of loperamide in plasma peak about 4 hours
after ingestion of large doses.
HALF-LIFE
The elimination half-life of loperamide is about 10 hours.
DISTRIBUTION
Loperamide does not penetrate well into the brain. Little
intact drug reaches the systemic circulation Gastrointestinal
Tract: 85%, Liver: 5%, Tissues: 0.04 to 0.2%. The plasma
protein binding of loperamide is 95%, mainly to albumin.
PROTEIN BINDING
About 97% is bound to plasma protein.
METABOLISM
Loperamide undergoes first-pass metabolism in the liver.
Loperamide undergoes significant first pass