NICRON 80mg Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

GLICLAZIDE

Boleh didapati daripada:

Noripharma Sdn. Bhd.

INN (Nama Antarabangsa):

GLICLAZIDE

Unit dalam pakej:

60 Tablets; 100 Tablets; 120 Tablets; 500 Tablets; 1000 Tablets

Dikeluarkan oleh:

Noripharma Sdn. Bhd.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP)_
_ _
NICRON 80MG TABLET
Gliclazide 80mg
1 | P a g e
WHAT IS IN THIS LEAFLET?
1.
What NICRON 80mg used for
2.
How NICRON 80mg works
3.
Before you use NICRON 80mg
4.
How to use NICRON 80mg
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
NICRON 80mg
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision.
WHAT NICRON 80MG USED FOR
NICRON is used in a certain form
of
diabetes
(type
2
diabetes
mellitus)
in
adults,
when
diet,
exercise and weight loss alone do
not
have
an
adequate
effect
on
keeping blood sugar at the correct
level
HOW NICRON 80MG WORKS
NICRON is a medicine that reduces
blood sugar levels (oral antidiabetic
medicine
belonging
to
the
sulfonylurea group).
BEFORE YOU USE NICRON 80MG
-_WHEN YOU MUST NOT USE IT_
Do not take NICRON :
-
if you are allergic to Gliclazide, to
other
sulfonylureas
or
sulfonamides
or
to
one
of
excipients included, - if you have
diabetes requiring treatment with
insulin,
-
in case of diabetes complicated by
ketoacidosis, diabetic precoma,
-
if you suffer from severe liver or
kidney disease,
-
if
you
are
presently
taking
a
treatment with miconazole (Refer
to “Taking other medicines”),
-
if you are breast-feeding.
Pregnancy and breastfeeding
If you are pregnant, your diabetes
should
be
treated
with
insulin.
If
you discover that you are pregnant
while
taking
this
medication,
you
should discontinue your treatment.
Tell your doctor, who will adjust
your hypoglycemic treatment. This
medication is contraindicated when
breast-feeding.
Ask your doctor or your pharmacist
for
advice
before
taking
any
medicine.
_- BEFORE YOU START TO USE IT _
WARNINGS
Hypoglycaemia: (decrease in blood
sugar levels)
You may suffer from hypoglycemia
in the course of your treatment. If
this happens, it may be necessary to
hospitalize you to restore your sugar
levels.
After
a
hypoglycemic
episode, your doctor will
monitor
you closely for at least 24 hours.
The
following
information
is
necessary
to
avoid
epis

Ciri produk

NICRON 80MG TABLET
COMPOSITION
Gliclazide
80mg/tablet
PRODUCT DESCRIPTION
A white to off white round shaped tablet with double score line on one
side and plain on other side.
PHARMACODYNAMICS
Gliclazide is a second generation sulphonylurea oral hypoglycaemic
agent. Gliclazide reduces blood
glucose
levels
by
stimulating
the
insulin
secretion
βcells
in
the
islets
of
Langerhans.
Unstimulated
and
stimulated
insulin
secretion
from
pancreatic
β-cells
are
increased
following
administration of Gliclazide. This occurs via the binding of
Gliclazide to specific receptor on pancreatic β-
cells which results in a decrease in potassium efflux and causes
depolarisation of the cell. Subsequently,
calcium channels open, leading to an increase in intracellular calcium
and induction of insulin release. In
addition, Gliclazide increases the sensitivity of β-cells to glucose.
A significant increase in insulin
response is seen in response to stimulation induced by a meal or
glucose.
_Haemovascular properties:_ Gliclazide decreases microthrombosis by
two mechanisms which may be
involved in the complications of diabetes: A partial inhibition of
platelet aggregation and adhesion with
a
decrease
in
the
markers
of
platelet
activation
(beta-thromboglobulin,
thromboxane
B2),
an action on the vascular endothelium fibrinolytic activity with an
increase in tPA activity.
PHARMACOKINETICS
_Absorption:_ Gliclazide is rapidly absorbed from the gastrointestinal
tract and maximum blood
concentrations are attained between the 11th and the 14th hour.
_Distribution: _In humans, binding to proteins is 94.2%. Metabolism is
extensive and all the metabolites
are devoid of hypoglycaemic activity.
_Elimination: _As the apparent terminal elimination half-life for
Gliclazide is 20 hours in humans, the drug
can be administered in two daily doses.
Elimination is mainly in the urine: less than 1% of the dose ingested
is found unchanged in the urine.
INDICATION
Non-insulin dependent diabetes, in association with an adapted diet,
in cases where dietary measures