GLIMET 2mg1000mg SUSTAINED RELEASE TABLETS

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

GLIMEPIRIDE; METFORMIN HYDROCHLORIDE

Boleh didapati daripada:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

GLIMEPIRIDE; METFORMIN HYDROCHLORIDE

Unit dalam pakej:

10Tablet Tablets

Dikeluarkan oleh:

TORRENT PHARMACEUTICALS LTD.

Risalah maklumat

GLIMET TABLETS
_ _
Glimepiride / Metformin Hydrochloride (1mg / 500mg , 2mg / 1000mg)
_ _
_ _
1
_ _
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is GLIMET used for
2.
How GLIMET works
3.
Before you use GLIMET
4.
How to use GLIMET
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of GLIMET
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT GLIMET IS USED FOR
GLIMET is used as an adjunct to diet
and exercise in non-insulin dependent
diabetes
mellitus
(NIDDM)
(Type
2)
patients
who
are
unable
to
achieve
sufficient
sugar
control
with
monotherapy
of
Metformin
or
Glimepiride alone or who are already
treated
with
the
combination
of
Metformin and Glimepiride as separate
tablets.
HOW GLIMET WORKS
GLIMET
contains
medicines
called
Glimepiride
and
Metformin
hydrochloride.
Glimepiride is an oral glucose-lowering
drug of the sulphonylureas class, which
acts by increasing the release of insulin
from
the
pancreatic
beta
cells.
This
results in opening of calcium channels
&
increase
in
intracellular
calcium.
Thus insulin level in increased.
Metformin, a biguanides class, reduces
the output of glucose from the liver and
thus reduces the requirement of insulin
at the level of liver.
Thus,
sulphonylureas
and
biguanides
have
additive
action.
Moreover,
Metformin and Glimepiride are often co
prescribed in clinical practice, and have
proven to be efficacious in achieving
the target glycemic control and also in
preventing
the
multiple
metabolic
defects,
which
are
often
present
in
diabetic subjects.
BEFORE YOU USE GLIMET
-
_When you must not use it _
Do not take GLIMET if:
•
You
are
allergic
(hypersensitive)
to:
-
Glimepiride.
-
Other
sulfonylureas
(medicines used to lower your
blood
sugar
such
as
glibenclamide).
-
Sulfonamides
(medicines
for
bacterial
infections
such
as
sulfamethoxazole).
-
Metformin.
-
Any of the other ingredients.
•
An allergic reaction can include a
rash, itching or shortness of breath.
•
You
have
insulin
dependent

Ciri produk

mortality. So the blood glucose level must be closely monitored during
pregnancy in order to avoid the teratogenic risk. The use of insulin
is required
under such circumstances. Patients who consider pregnancy should
inform
their physician.
There are no adequate data from the use of glimepiride in pregnant
women.
Animal studies have shown reproductive toxicity which likely was
related to the
pharmacologic action (hypoglycaemia) of glimepiride.
The excretion in human milk is unknown; however, Glimepiride is
excreted in
rat milk. As other sulfonylureas are excreted in human milk and
because there
is a risk of hypoglycaemia in nursing infants, it is advised to
discontinue
breastfeeding during treatment with Glimet.
PEDIATRIC USE
There are no adequate studies for safety and effectiveness of
Glimepiride in
pediatric population.
_METFORMIN:_
LACTIC ACIDOSIS:
Metformin is not generally recommended for patients with IDDM. But if
this
drug is planned to be given, it is always as an adjunct to insulin
therapy in
patients
who
are
not
at
risk
of
ketoacidosis.
Impaired
renal
function
predisposes to lactic acidosis. A normal creatinine clearance is
essential for
treatment with Metformin. Serum creatinine should be monitored
regularly
during Metformin therapy.
Lactic acidosis, which may be caused by Metformin, is of the Type B
and is not
associated with reduced tissue perfusion and hypoxia. Theoretically,
diabetics
may be predisposed to Type B lactic acidosis since insulin deficiency
is
associated with low levels of pyruvate dehydrogenase in the muscle,
which
may increase lactate production. Diabetics also tend to overproduce
lactate
during exercise. In spite of this predisposition Type B lactic
acidosis is rare with
Metformin until renal impairment is present.
Even though Metformin is not associated with Type A lactic acidosis it
should
be given with caution to patients with risk factors for hypoxia such
as sepsis,
dehydration, congestive heart failure, seizures or alcoholism.
Lactic acidosis in patients with malignancy is tho