Diabetmin XR 750 mg Tablets

Country: Малезија

Језик: Енглески

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

Активни састојак:

METFORMIN HYDROCHLORIDE

Доступно од:

HOVID BERHAD

INN (Међународно име):

METFORMIN HYDROCHLORIDE

Јединице у пакету:

60 Tablets; 100 Tablets; 30 Tablets

Произведен од:

HOVID BERHAD

Информативни летак

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DIABETMIN XR TABLETS
METFORMIN HYDROCHLORIDE 750MG & 1000MG
1
WHAT IS IN THIS LEAFLET
1.
What Diabetmin XR Tablets is
used for
2.
How Diabetmin XR Tablets works
3.
Before you take Diabetmin XR
Tablets
4.
How to take Diabetmin XR Tablets
5.
While you are taking Diabetmin
XR Tablets
6.
Side effects
7.
Storage and Disposal of Diabetmin
XR Tablets
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DIABETMIN XR TABLETS IS USED
FOR
Diabetmin XR tablets contain the active
ingredient metformin hydrochloride
and belong to a group of medicines
called biguanides, used in the treatment
of diabetes.
Diabetmin XR is used to delay the
onset and treat Type 2 (non-insulin
dependent) diabetes mellitus in adults,
when diet and exercise changes alone
have not been enough to control blood
glucose (sugar). Diabetmin XR may be
used as monotherapy or in combination
with other oral antidiabetic agents or
with insulin.
HOW DIABETMIN XR TABLETS WORKS
Insulin is a hormone produced by the
pancreas that makes your body take in
glucose (sugar) from the blood. Your
body uses glucose to produce energy or
stores it for future use.
If
you
have
diabetes,
your
pancreas
does not make enough insulin or your
body is not able to use properly the
insulin it produces. This leads to a high
level
of
glucose
in
your
blood.
Diabetmin XR Tablets makes the body
more
sensitive
to
insulin
and
helps
return to normal the
way your body
uses glucose. Diabetmin XR Tablets is
associated
with
either
a
stable
body
weight or modest weight loss.
Diabetmin
XR
Tablets
are
specially
made to release the drug slowly in your
body.
BEFORE YOU TAKE DIABETMIN XR
TABLETS
_- When you must not use it _
Do not take this medicine if:
•
you are allergic to metformin or to
any of the other ingredients which
are listed later on in the leaflet.
•
If
you
have
severely
reduced
kidney function.
•
If
you
have
lactic
acidosis
[too
much lactic acid in the blood (see
“Risk of lactic acidosis”

Карактеристике производа

xxx
DIABETMIN XR TABLETS
VIDIAxx-09 (MY HK)
DESCRIPTION
DIABETMIN XR 750MG TABLETS: 21x9mm, Oblong, white to off-white
uncoated tablet with deep convex faces and “HOVID” embossed on
one face.
DIABETMIN
XR
1000MG
TABLETS:
23x11mm,
Oblong,
white
to
off-white uncoated tablet, biconvex faces and “HOVID” embossed on
one face.
COMPOSITION
DIABETMIN XR 750MG TABLETS: Metformin hydrochloride 750mg
equivalent to 585mg of metformin base (Extended Release).
DIABETMIN XR 1000MG TABLETS: Metformin hydrochloride 1000mg
equivalent to 780mg of metformin base (Extended Release).
ACTIONS AND PHARMACOLOGY
Metformin is a biguanide with antihyperglycaemic effects, lowering
both basal and postprandial plasma glucose. It does not stimulate
insulin secretion and therefore does not produce hypoglycaemia.
Metformin may act via 3 mechanisms:
•
Reduction
of
hepatic
glucose
production
by
inhibiting
gluconeogenesis and glycogenolysis
•
In muscle, by increasing insulin sensitivity, improving peripheral
glucose uptake and utilisation
•
And, delay of intestinal glucose absorption Metformin stimulates
intracellular glycogen synthesis by acting on glycogen synthase.
Metformin
increases
the
transport
capacity
of
all
types
of
membrane glucose transporters (GLUT).
PHARMACOKINETICS
ABSORPTION
After
an
oral
dose
of
the
prolonged
release
tablet,
metformin
absorption is significantly delayed compared to the immediate release
tablet with a Tmax at 7 hours (Tmax for the immediate release tablet
is
2.5
hours). At
steady
state,
similar
to
the
immediate
release
formulation, C
max
and AUC are not proportionally increased to the
administered dose. The AUC after a single oral administration of 2000
mg of metformin prolonged release tablets is similar to that observed
after administration of 1000 mg of metformin immediate release tablets
b.i.d. Intrasubject variability of C
max
and AUC of metformin prolonged
release is comparable to that observed with metformin immediate
release tablets. When the prolonged release tablet is administered in
fasting c