METTA SR Tablet 500mg

Valsts: Malaizija

Valoda: angļu

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

Aktīvā sastāvdaļa:

METFORMIN HYDROCHLORIDE

Pieejams no:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

SNN (starptautisko nepatentēto nosaukumu):

METFORMIN HYDROCHLORIDE

Vienības iepakojumā:

30Tablet Tablets; 60 Tablet Tablets; 10 Tablet Tablets; 100 Tablet Tablets

Ražojis:

TORRENT PHARMACEUTICALS LTD.

Lietošanas instrukcija

METTA SR TABLET
_ _
Metformin Hydrochloride (500 mg, 750 mg)
_ _
_ _
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is Metta SR used for
2.
How Metta SR works
3.
Before you use Metta SR
4.
How to use Metta SR
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Metta SR
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT METTA SR IS USED FOR
Metformin is used for the treatment of
Type
2
(non-insulin
dependent)
diabetes
mellitus
when
diet
and
exercise changes alone have not been
enough
to
control
blood
glucose
(sugar).
HOW METTA SR WORKS
Metformin
is
an
antihyperglycemic
agent (lowering glucose levels in the
blood). People with Type 2 diabetes do
not
make
enough
insulin
in
their
pancreas or their body does not respond
properly to the insulin it does make.
This causes a build-up of glucose in the
blood
which
can
cause
a
number
of
serious long-term problems. Metformin
SR makes the body more sensitive to
insulin and helps return to normal the
way your body uses glucose.
BEFORE YOU USE METTA SR
-
_When you must not use it _
Do not take Metta SR if you:
•
Have
long-term
kidney
or
liver
problems.
•
Have
been
treated
for
heart
problems or have recently had a
heart
attack
or
have
severe
circulatory problems or breathing
difficulties.
•
Are allergic to metformin or to any
of the other ingredients.
•
Have ketosis (this is a symptom of
uncontrolled
diabetes
in
which
substances called ‘ketone bodies’
accumulate in the blood – you may
notice
that
your
breath
has
an
unusual, fruity odour).
•
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).
_Pregnancy and lactation _
_ _
_ _
Do
not
take
Metta
SR
if
you
are
pregnant, tryi

Produkta apraksts

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COMPOSITION
METTA SR TABLETS 750 MG
Each extended release tablet contains
Metformin Hydrochloride USP….750mg.
Colour: Red oxide of iron
METTA SR TABLETS 500 MG
Each extended release tablet contains
Metformin Hydrochloride USP….500mg.
PRODUCT DESCRIPTION:
METTA SR TABLETS 500 MG:
White to off-white coloured, capsule shaped, biconvex tablets with
‘Torrent logo’ debossed on one side and ‘500’ on the other
side.
METTA SR TABLETS 750 MG:
Pale red colored, capsule shaped, biconvex tablets with ‘Torrent
logo’ debossed on one side and ‘750’ on the other side.
CLINICAL PHARMACOLOGY
_PHARMACODYNAMICS_
Metformin is an antihyperglycemic agent, which improves glucose
tolerance in patients with, type II diabetes, lowering both basal and
postprandial
plasma glucose. Its pharmacologic mechanisms of action are different
from other classes of oral antihyperglycemic agents. Metformin
decreases
hepatic glucose production, decreases intestinal absorption of
glucose, and improves insulin sensitivity by increasing the peripheral
glucose
uptake and utilization. Unlike sulfonylureas, Metformin does not cause
hypoglycemia in either with patients with type II diabetes or normal
individuals.
_PHARMACOKINETICS_
ABSORPTION
Metformin is absorbed incompletely after oral administration, about
30% of an oral dose recovered from the faeces. Oral bioavailability is
about
50-60%. The drug may undergo some minor degree of first pass
metabolism. It also gets concentrated in the walls of oesophagus,
stomach and
duodenum. Bioavailability is not improved when Metformin is given as
an aqueous solution or rapidly dissolving tablets. Extended release
formulations give lower bioavailability, as also do higher doses. Mean
study state plasma levels of 505mcg/L were reached in 13 patients with
doses of 1240 ± 560mg/day. Concominant food intake may slightly
impair absorption.
Following a single oral dose of Metformin Hydrochloride Cmax is
achieved with a median value of 7 hours and a range of 4 to 8 hours.
Food did
not have any