Glucomin 500mg Tablet

Country: Malasía

Tungumál: enska

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

Kauptu það núna

Vara einkenni Vara einkenni (SPC)
21-08-2019

Virkt innihaldsefni:

METFORMIN HYDROCHLORIDE

Fáanlegur frá:

Noripharma Sdn. Bhd.

INN (Alþjóðlegt nafn):

METFORMIN HYDROCHLORIDE

Einingar í pakka:

60 Tablets; 100 Tablets; 500 Tablets

Framleitt af:

Noripharma Sdn. Bhd.

Upplýsingar fylgiseðill

                                GLUCOMIN 500MG TABLET
Metformin Hydrochloride 500mg
Page | 1
_Consumer Medication Information Leaflet (RiMUP) _
WHAT IS IN THIS LEAFLET
1.
What GLUCOMIN 500 is used
for?
2.
How GLUCOMIN 500 works
3.
Before
you
use
GLUCOMIN
500
4.
How to take GLUCOMIN 500
5.
While
you
are
using
GLUCOMIN 500
6.
Side effects
7.
Storage
and
disposal
of
GLUCOMIN 500
8.
Product description
9.
Manufacturer
and
product
registration Holder
10.
Date of revision
WHAT
GLUCOMIN
500
IS
USED
FOR?
Metformin is used for the sort of
diabetes called Type 2 diabetes or
non-insulin-dependent
diabetes
mellitus.
GLUCOMIN
500
is
used
to
treat
patients with type 2 diabetes (also
called
'non-insulin
dependent
diabetes')
when
diet
and
exercise
alone
have
not
been
enough
to
control your blood glucose levels. It
is
used
particularly
in
overweight
patients.
Adults can take GLUCOMIN 500 on
its
own
or
together
with
other
medicines
to
treat
diabetes
(medicines
taken
by
mouth
or
insulin).
Children
10
years
and
over
and
adolescents can take GLUCOMIN
500
on
its
own
or
together
with
insulin
HOW GLUCOMIN 500 WORKS
• In type 2 diabetes, there is too
much sugar (glucose) in your blood.
This is because your body does not
make enough insulin
or
because
it
makes
insulin
that
does not work properly.
• Insulin is a hormone that allows
your
body
tissue
to
take
glucose
from the blood and use it for energy
or for storage for future use.
•
Metformin
works
by
improving
the
sensitivity
of
your
body
to
insulin. It helps your body to use
glucose in the normal way again
BEFORE YOU USE GLUCOMIN 500
_When you must not take it _
Do not take Glucomin 500 :_ _

_ _
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).

_ _
you
are
a
                                
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Vara einkenni

                                GLUCOMIN 500MG TABLET
DESCRIPTION:
A white to off white round shaped film coated tablet with breaking
line on one side.
COMPOSITION: Each film coated tablet contains Metformin hydrochloride
500mg.
PHARMACODYNAMIC:
Metformin is a biguanide derivative of guanidine, used for treating
type II diabetes mellitus.
It has antihyperglycaemic effects, which lowers both basal and
postprandial plasma glucose.
It does not increase insulin secretion and hence, does not cause
hypoglycaemia.
Metformin acts via 3 mechanisms:

reduction in hepatic glucose production,

reduction in intestinal glucose absorption, and

Increased insulin sensitivity (improved peripheral glucose uptake and
utilization).
Metformin stimulates intracellular glycogen synthesis by acting on
glycogen synthase. Metformin
increases the transport capacity of all types of membrane glucose
transporters (GLUTs).In humans,
independently of its action on glycaemia, metformin has favourable
effects on lipid metabolism.
PHARMACOKINETICS
Absorption
Absolute bioavailability of a 500 mg metformin hydrochloride tablet is
approximately 50-
60% in healthy subjects. After an oral dose, the non-absorbed fraction
recovered in faeces
was 20-30%.
After oral administration, metformin absorption is saturable and
incomplete. It is assumed
that the pharmacokinetics of metformin absorption is non-linear.
At
the
recommended
metformin
doses
and
dosing
schedules,
steady
state
plasma
concentrations are reached within 24 to 48 hours and are generally
less than 1 microgram/ml.
Food decreases the extent and slightly delays the absorption of
metformin.
Distribution
Plasma protein binding is negligible. Metformin partitions into
erythrocytes. The blood peak
is lower than the plasma peak and appears at approximately the same
time. The red blood
cells most likely represent a secondary compartment of distribution.
The mean volume of
distribution (Vd) ranged between 63-276 l.
Metabolism
Metformin is excreted unchanged in the urine. No metabolites have been
identified in
humans.
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