GLIBETA TABLETS (5mg + 500mg)

البلد: ماليزيا

اللغة: الإنجليزية

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

العنصر النشط:

GLIBENCLAMIDE; METFORMIN HYDROCHLORIDE

متاح من:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (الاسم الدولي):

GLIBENCLAMIDE; METFORMIN HYDROCHLORIDE

الوحدات في الحزمة:

10tablet Tablets; 100tablet Tablets; 100tablet Tablets; 120tablet Tablets

المصنعة من قبل:

TORRENT PHARMACEUTICALS LTD

نشرة المعلومات

GLIBETA TABLETS
(5MG + 500MG)
_ _
Glibenclamide and Metformin Hydrochloride (5mg + 500mg)
_ _
_ _
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is GLIBETA used for
2.
How GLIBETA works
3.
Before you use GLIBETA
4.
How to use GLIBETA
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of GLIBETA
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT GLIBETA IS USED FOR
Your doctor has prescribed GLIBETA
to treat your type 2 diabetes. This is
also
known
as
non-insulin-dependent
diabetes mellitus.
HOW GLIBETA WORKS
GLIBETA
combines
2
glucose
lowering
drugs,
glibenclamide
and
metformin.
These 2 drugs work together to improve
the different metabolic defects found in
type 2 diabetes. Glibenclamide lowers
blood sugar primarily by causing more
of
the
body’s
own
insulin
to
be
released, and metformin lowers blood
sugar, in part, by helping your body use
your own insulin more effectively.
Together, they are efficient in helping
you to achieve better glucose control.
BEFORE YOU USE GLIBETA
-
_When you must not use it _
Do not take GLIBETA if you:
•
Are
allergic
(hypersensitive)
to
glibenclamide,
metformin
other
sulphonylureas or any of the other
ingredients in Tablets.
•
Suffer from early onset or type I
diabetes (requiring insulin).
•
Suffer from severe kidney disease.
•
Suffer from liver problems.
•
Are suffering from any condition
likely
to
make
controlling
your
blood sugar difficult.
•
Are due to undergo surgery.
•
Are pregnant.
•
Have
reduced
consciousness
or
coma resulting from your diabetes.
•
Are elderly (over 70 years of age).
•
Have reduced kidney function.
•
Have
lactic
acidosis
[too
much
lactic acid in the blood (see “Risk
of
lactic
acidosis”
below)]
or
ketoacidosis.
Ketoacidosis
is
a
condition
in
which
substances
called ‘ketone bodies’ accumulate
in the blood and which can lead to
diabetic
pre-coma.
Symptoms
of
acidosis may include stomach pain,
abnormal breathing and drowsiness
(if seve

خصائص المنتج

1
For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory
GLIBETA TABLETS (5 MG + 500 MG)
(GLIBENCLAMIDE AND METFORMIN HYDROCHLORIDE TABLETS USP)
BRAND OR PRODUCT NAME
GLIBETA TABLETS (5 mg + 500 mg)
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
GLIBETA TABLETS (5 mg + 500 mg)
Each film coated tablet contains:
Glibenclamide USP…………………5 mg
Metformin Hydrochloride USP…….500 mg
Colours: Yellow oxide of Iron & Titanium Dioxide
PRODUCT DESCRIPTION
Yellow colored, capsule shaped, biconvex, film coated tablets debossed
with “5” on one side
and plain on other side.
DOSAGE FORM
Film coated tablet
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Glibeta tablet combines Glibenclamide and metformin hydrochloride, 2
antihyperglycemic
agents with complementary mechanisms of action, to improve glycemic
control in patients with
type 2 diabetes.
Glibenclamide appears to lower blood glucose acutely by stimulating
the release of insulin
from the pancreas, an effect dependent upon functioning beta cells in
the pancreatic islets. The
mechanism by which Glibenclamide lowers blood glucose during long-term
administration has
not been clearly established. With chronic administration in patients
with type 2 diabetes, the
blood glucose-lowering effect persists despite a gradual decline in
the insulin secretory
response to the drug. Extra pancreatic effects may be involved in the
mechanism of action of
oral sulfonylurea hypoglycemic drugs.
Metformin hydrochloride is an antihyperglycemic agent that improves
glucose tolerance in
patients with type 2 diabetes, lowering both basal and postprandial
plasma glucose. Metformin
hydrochloride decreases hepatic glucose production, decreases
intestinal absorption of glucose,
and improves insulin sensitivity by increasing peripheral glucose
uptake and utilization.
PHARMACOKINETICS
Absorption and Bioavailability
_FDC METFORMIN AND GLIBENCLAMIDE _
Following administration of a single FDC Metformin and Glibenclamide 5
mg/500 mg tablets
with either a 20% glucose solution or a 2