Glumil 850mg Tablet

Država: Malezija

Jezik: angleščina

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

Aktivna sestavina:

METFORMIN HYDROCHLORIDE

Dostopno od:

MILRIN PHARMACEUTICAL CO. (M) SDN BHD

INN (mednarodno ime):

METFORMIN HYDROCHLORIDE

Enote v paketu:

10 blister x 10tablet Tablets

Izdeluje:

The United Drug (1996) Co.,Ltd.

Navodilo za uporabo

GLUMIL 850MG TABLET
Metformin Hydrochloride 850mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Glumil is used for
2.
How Glumil works
3.
Before you use Glumil
4.
How to use Glumil
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Glumil
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT GLUMIL IS USED FOR
Glumil is used for the treatment of type 2
diabetes.
HOW GLUMIL WORKS
Glumil
decrease
hepatic
glucose
production,
decreasing
intestinal
absorption
of
glucose
and
improves
insulin
sensitivity
(increases
peripheral
glucose uptake and utilization).
BEFORE YOU USE GLUMIL
-
_When you must not use it _
Glumil should not be used by anyone
who is allergic to any of the ingredients
of the medication.
Do not take Glumil :

If you have severely reduced kidney
function.

If
you
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 severe).
-
_Before you start use it _
_ _
Inform your physician of any medical
conditions or allergies you may have,
any
medications
you
are
taking,
whether you are pregnant or breast-
feeding, and any other significant facts
about your health. These factors may
affect
how
you
should
use
this
medication.
Risk of lactic acidosis
Glumil may cause a very rare, but very
serious
side
effect
called
lactic
acidosis, particularly if your kidneys
are not working properly. The risk of
developing
lactic
acidosis
is
also
increased with uncontrolled diabetes,
serious infections, prolonged fasting or
alcohol
intake,
dehydration,
liver
problems and any medical conditions
in
which
a
part
of
the
body
has
a
reduced supply of oxygen ( such as
acute severe heart disease) If any of
the above apply to you, talk to your
doctor for

Lastnosti izdelka

GLUMIL
850mg Tablet
Metformin HCl 850mg
PRODUCT NAME :
Glumil 850 mg Tablet
NAME AND STRENGTH OF ACTIVE SUBSTANCE :
Each tablet contains : Metformin Hydrochloride 850 mg
PRODUCT DESCRIPTION :
Round, biconvex, white film-coated tablet, engraved “850” on one
side, and scored on another side.
PHARMACODYNAMICS :
Metformin hydrochloride is a biguanide oral antihyperglycemic drug
used in the management of type 2 diabetes mellitus. It
decreased hepatic glucose production, decreasing intestinal absorption
of glucose and improves insulin sensitivity
(increases peripheral glucose uptake and utilization).
PHARMACOKINETICS :
The absolute bioavailability of Metformin is approximately 50% to 60%.
The apparent volume of distribution (V/F) following
single oral doses of Metformin hydrochloride 850 mg averaged 654±358
L. Metformin is negligibly bound to plasma proteins, in
contrast to sulfonylureas, which are more than 90% protein bound. At
usual clinical doses and dosing schedules, steady-
state plasma concentrations of Metformin are reached within 24 to 48
hours and are generally less than 1 µg/mL. Metformin
is excreted unchanged in the urine. Following oral administration,
approximately 90% of the absorbed drug is eliminated
in the unchanged form via the renal route within the first 24 hours,
with a plasma elimination half-life of approximately 6.2
hours.
INDICATIONS :
Glumil 850 mg Tablet is an oral antidiabetic agent (biguanide)
intended for the treatment of type 2 diabetes.
Glumil 850 mg Tablet may be given alone or with oral antidiabetic
agents, or with insulin. A reduction of diabetic
complications has been shown in overweight type 2 diabetic adult
patients treated with metformin as first-line therapy after diet
therapy.
RECOMMENDED DOSAGE :
The dosage of Glumil 850 mg Tablet is determined by your doctor on an
individual basis according to the results of laboratory
blood glucose measurement. The initial dosage may be increased as
necessary to be one tablet 2 or 3 times daily in adults.
The maximum recommended dose i