DIATROL TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LOPERAMIDE HYDROCHLORIDE

Boleh didapati daripada:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

LOPERAMIDE HYDROCHLORIDE

Unit dalam pakej:

500Tablet Tablets; 1000Tablet Tablets; 100 Tablet Tablets; 50 Tablet Tablets; 80 Tablet Tablets; 500 Tablets; 1000 Tablets

Dikeluarkan oleh:

SUNWARD PHARMACEUTICAL SDN. BHD.

Risalah maklumat

1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DIATROL TABLET
Loperamide Hydrochloride
(
2mg)
WHAT IS IN THIS LEAFLET
1.What Diatrol Tablet is used for
2. How Diatrol Tablet works
3. Before you use Diatrol Tablet
4. How to use Diatrol Tablet
5. While you are using Diatrol Tablet
6. Side Effects
7. Storage and Disposal of Diatrol Tablet
8. Product Description
9. Manufacturer and Product Registration
Holder
10.Date of Revision
WHAT DIATROL TABLET IS USED FOR
Diatrol
Tablet
is
used
for
control
and
symptomatic
relief
of
acute,
non
specific
diarrhea and chronic diarrhea associated with
inflamantory bowel disease. In people
with
ileostomy(surgical procedure in which small
intestine is diverted through an opening in the
abdomen to move waste out of the body), it
can be used to reduce the number and volume
and harden the stools.
HOW DIATROL TABLET WORKS
The active ingredient in the medicine
is loperamide prolongs the transit time of
the intestinal contents. It reduces the daily
faecal volume, increases the viscosity and bulk
density, and diminishes the loss of fluid and
electrolytes by both increasing the intestinal
absorption
and
decreasing
intestinal
secretions.
BEFORE YOU USE DIATROL TABLET
_- When you must not use it _
Do not take Diatrol Tablet:

If
you
have
known
hypersensitivity
to
Loperamide
or
other
ingredients
of
this
product.

If you have colon constipation.

If you have acute inflammation of the
colon which can be associated with broad
spectrum antibiotics.

If
you
have
acute
dysentery
which
is
characterized by blood in stools and high
fever.

If children under 6 years of age.

If you are breastfeeding
_- Before you start to use it _
You should check with your doctor:-

If you are or think you may be pregnant

If you are planning to become pregnant

If you have diabetes

If you are having acute diarrhea associat-
ed with bacteria

If you are depleting water and salts

If you have liver failure

If you are having acute diarrhea and your
condition does not improve af

Ciri produk

DIATROL TABLET
Each tablet contains:
Loperamide HCl 2 mg
PHARMACOLOGY:
In man, loperamide prolongs the transit time of the intestinal
contents. It reduces the daily faecal volume,
increases the viscosity and bulk density, and diminishes the loss of
fluid and electrolytes by both
increasing the intestinal absorption and decreasing intestinal
secretions. Tolerance to the anti-diarrhoeal
effects has not been observed.
Clinical studies have indicated that the apparent elimination half
life of loperamide in man is 10.8 hours
with a range of 9.1 to 14.4 hours. Plasma levels of unchanged drug
remain below 2 nanograms per ml after
the intake of 2mg of Loperamide Hydrochloride. Plasma levels are
highest approximately five hours after
administration of the capsule dosage form. Of the total excreted in
urine and faeces, most of the
administered drug was excreted in faeces.
INDICATIONS:
Loperamide HCI is indicated for the control and symptomatic relief of
acute, nonspecific diarrhoea and of
chronic diarrhoea associated with inflammatory bowel disease. In
patients with ileostomy it can be used to
reduce the number and volume of stools and to harden their
consistency.
SIDE EFFECTS/ADVERSE REACTIONS:
Adverse experiences recorded during clinical studies with Loperamide
HCI were generally of a minor and
self-limiting nature. They were more commonly observed during the
treatment of chronic diarrhoea. The
following complaints have been reported : abdominal pain,
constipation, drowsiness or dizziness, dry
mouth, nausea and vomiting, tiredness, hypersensitivity reactions
(including skin rash).
Post-marketing Experience:
Cardiac Disorders: QTIQTc interval prolongation, Torsades de Pointes,
other ventricular arrhythmias, cardiac arrest,
syncope, and death (see Warnings and Precautions).
PRECAUTIONS/WARNINGS:
Antiperistaltic agents should not be used in acute diarrhoea
associated with organisms that penetrate the
intestinal mucosa eg. enteroinvasive E. Coli, Salmonella, Shigella.
Fluid and electrolytes depletion may occur in patients wh