GLIMICRON 80MG TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

GLICLAZIDE

Boleh didapati daripada:

HOVID BERHAD

INN (Nama Antarabangsa):

GLICLAZIDE

Unit dalam pakej:

100 Tablet Tablets

Dikeluarkan oleh:

HOVID BERHAD

Risalah maklumat

GLIMICRON 80MG TABLET
Gliclazide 80mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Glimicron Tablet is used for
2.
How Glimicron Tablet works
3.
Before you use Glimicron
4.
How to use Glimicron Tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Glimicron
Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT GLIMICRON TABLET IS USED FOR
Glimicron tablet is used for Non-Insulin
Dependent Diabetes Mellitus (NIDDM).
HOW GLIMICRON TABLET WORKS
Glimicron tablet belongs to a group of
medicines called sulfonylureas.
These medicines lower blood glucose by
promoting the release of insulin
from
pancreas.
If
your
blood
glucose
is
not
properly
controlled,
you
may
experience
or
hypoglycaemia
(low
blood
glucose)
or
hyperglycaemia (high blood glucose).
BEFORE YOU USE GLIMICRON TABLET
-
_When you must not use it _
Do not take Glimicron if you are allergic
to:
•
medicines containing gliclazide
•
sulfonamide ("sulfa") antibiotics or
"sulfa" medicines including
sulfamethoxazole
and
acetazolamide
•
any of the ingredients of this
medicine
Some of the symptoms of an allergic
reaction may include skin rash, itching or
hives; swelling of the face, lips or tongue
which may cause difficulty in swallowing
or breathing; wheezing and shortness of
breath.
Do not take Glimcron if you have any of
the following medical conditions:
•
Type
1
diabetes
mellitus,
also
known
as
insulin
dependent
diabetes or juvenile onset diabetes
•
unstable diabetes that is not well
controlled
•
diabetic ketoacidosis, or a history of
repeated
episodes
of
ketoacidosis
(this
a
symptom
of
uncontrolled
diabetes, in which substances called
ketone bodies build up in the blood)
•
diabetic coma or pre-coma, which
may
follow
on
from
diabetic
ketoacidosis mentioned above
•
severe kidney disease
•
severe liver disease
•
acidosis
•
burns
•
diabetic coma
•
infection
•
ketosis
•
surgery and trauma.
Risk-benefit should be considered when
the

Ciri produk

DESCRIPTION
Round, 8.0 mm in diameter, white to off-white uncoated tablet,
flat faces, bevel-edged, cross score embossed on one face.
COMPOSITION
Gliclazide 80 mg / tablet
ACTION & PHARMACOLOGY
Gliclazide, a sulphonylurea, acts by promoting release of
insulin from the beta cells of pancreatic islet tissue by an
unknown
process.
Insulin
production
is
not
increased.
Hepatic glycogenolysis and gluconeogenesis are decreased.
Insulin sensitivity is increased at peripheral target sites.
Therefore, sulfonylureas are effective only in patients whose
pancreas are capable of producing insulin.
PHARMACOKINETICS
•
ABSORPTION
It is readily absorbed from the gastro-intestinal tract.
•
PROTEIN BINDING
Gliclazide is very extensively bound to plasma proteins.
•
METABOLIC REACTIONS
It is extensively metabolized in the liver to metabolites
without significant hypoglycaemic activity.
•
HALF-LIFE
Plasma half-life is about 10 to 12 hours.
•
EXCRETION
Both unchanged drug and metabolites are excreted in the
urine.
INDICATIONS
Gliclazide is indicated in non-insulin dependent diabetes
mellitus.
CONTRAINDICATIONS
•
Except under special circumstances, this medication
should not be used when the following medical problems
exist:
Acidosis,
burns,
diabetic
coma,
infection,
ketoacidosis, ketosis, surgery and trauma.
•
Risk-benefit should be considered when the following
medical problems exist: Adrenal insufficiency, pituitary
insufficiency, fever, nausea, vomiting, thyroid function
impairment,
debilitated
physical
condition,
hepatic
function
impairment,
malnourishment,
renal
function
impairment, sensitivity to oral antidiabetic agents and
patients with acute porphyria.
PRECAUTIONS/WARNINGS
•
Patients sensitive to one of the oral antidiabetic agents
may be sensitive to the others also.
•
Oral
antidiabetic
agents
must
not
be
used
during
pregnancy. Abnormal blood glucose levels have been
associated
with
a
higher
incidence
of
congenital
abnormalities during early pregnancy, and with increased
perinatal morbidity and mortality late