Metformin STELLA 850 mg Film-coated tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

METFORMIN HYDROCHLORIDE

Boleh didapati daripada:

STADPHARM SDN. BHD.

INN (Nama Antarabangsa):

METFORMIN HYDROCHLORIDE

Unit dalam pakej:

60'stablet Tablets

Dikeluarkan oleh:

STELLAPHARM J.V. Co., LTD. - BRANCH 1

Risalah maklumat

_ Consumer Medication Information Leaflet (RiMUP) _
METFORMIN STELLA 850 MG FILM- COATED TABLET
Active ingredient: Metformin hydrochloride 850 mg
1
WHAT IS IN THIS LEAFLET
1. What Metformin STELLA 850 mg is
used for
2. How Metformin STELLA 850 mg
works
3. Before you take Metformin STELLA
850 mg
4.How to take Metformin STELLA 850
mg
5. While you are using Metformin
STELLA 850 mg
6. Side effects
7. Storage and Disposal of Metformin
STELLA 850 mg
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT METFORMIN STELLA 850 MG IS
USED FOR
Metformin is used for the management of
type 2 diabetes mellitus (also called Non-
insulin-
dependent),
when
dietary
management and exercise alone does not
result in adequate glycaemic (the presence
of glucose in the blood) control.
Metformin may be used as alone or in
combination with other anti-diabetic agents
or with insulin in adults.
Children
from
10
years
of
age
and
adolescents can use metformin as alone or
in combination with insulin.
In type 1diabetes (also called insulin –
dependent), Metformin may be used as an
adjuvant
(pharmacological
agent
that
modifies
the
effect
of
other
drugs)
to
patients
whose
diabetic
are
poorly
controlled.
HOW METFORMIN STELLA 850 MG WORKS
Insulin is made naturally in the pancreas. It
maintains the correct amount of sugar in the
blood. People with type 2 diabetes are not
able to made enough insulin or respond
normally to the insulin their bodies make.
When this happens, sugar (glucose) builds up
in the blood, and this condition called
diabetes mellitus.
Metformin helps control your blood sugar in a
number of ways. These include helping your
body respond better to the insulin it makes
naturally,
decreasing
the
liver
glucose
production
and
intestinal
absorption
of
glucose,
increasing
the
peripheral
glucose
uptake and utilization. As metformin does not
cause your body to make more insulin, they
rarely cause hypoglycemia (low blood sugar)
when taken alone.
In
type
1
diabetes,
the
combination
of
metformin HCl a

Ciri produk

ADMINISTRATION
C
OMPOSITION
Metformin hydrochloride is slowly and incompletely absorbed from the
gastrointestinal tract; the absolute bioavailability of a single
500 mg dose is reported to be about 50 to 60%, although this is
reduced somewhat if taken with food. Once absorbed, protein binding
in plasma is negligible; the drug is excreted unchanged in the urine.
The plasma elimination half-life is reported to range from about 2
to 6 hours after oral doses. Metformin crosses the placenta and is
distributed into breast milk in small amounts.
One Metformin STELLA 850 mg film-coated tablet contains 850 mg
metformin hydrochloride.
INDICATIONS
-
In adults, metformin film-coated tablets may be used as monotherapy or
in combination with other oral anti-diabetic agents or with
insulin.
-
Treatment of type 2 diabetes mellitus, particularly in overweight
patients, when dietary management and exercise alone does not
result in adequate glycaemic control. In type 1 diabetes, it may be
given as an adjuvant to patients whose diabetic are poorly controlled.
-
In children from 10 years of age and adolescents, metformin
film-coated tablets may be used as monotherapy or in combination with
insulin.
Metformin hydrochloride is an anti-hyperglycemic agent which improves
glucose tolerance in patients with type-2 diabetes, lowering
both basal and postprandial plasma glucose. Metformin decreases
hepatic glucose production, decreases intestinal absorption of
glucose, and increases peripheral glucose uptake and utilization.
Unlike sulfonylureas, metformin does not produce hypoglycemia in
either patients with type-2 diabetes or normal subjects and does not
cause hyper-insulinemia. With metformin therapy, insulin
secretion remains unchanged while fasting insulin levels and day-long
plasma insulin response may actually decreases.
DOSAGE & ADMINISTRATION
DOSAGE
_ADULTS_
-
Monotherapy and combination with other oral anti-diabetic agents: The
usual starting dose is one tablet 2 or 3 times daily. After 10 to
15 days the dose should be adjusted on t