Royce Metformin Film-Coated Tablet 500mg

Country: মাল্যাশিয়া

ভাষা: ইংরেজি

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

সক্রিয় উপাদান:

METFORMIN HYDROCHLORIDE

থেকে পাওয়া:

ROYCE PHARMA MANUFACTURING SDN. BHD.

INN (International Name):

METFORMIN HYDROCHLORIDE

প্যাকেজ ইউনিট:

100 Tablets; 1000 Tablets; 500 Tablets

Manufactured by:

ROYCE PHARMA MANUFACTURING SDN. BHD.

তথ্য লিফলেট

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
ROYCE METFORMIN FILM-COATED TABLET
500MG
_ _
Metformin Hydrochloride (500mg)_ _
_ _
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Royce Metformin Film-Coated
Tablet 500mg is used for
2.
How Royce Metformin Film-Coated
Tablet 500mg works
3.
Before
you
use
Royce
Metformin
Film-Coated Tablet 500mg
4.
How to use Royce Metformin Film-
Coated Tablet 500mg
5.
While
you
are
using
Royce
Metformin
Film-Coated
Tablet
500mg
6.
Side effects
7.
Storage
and
disposal
of
Royce
Metformin
Film-Coated
Tablet
500mg
8.
Product description
9.
Manufacturer
and
Product
registration holder
10.
Date of revision
WHAT
ROYCE
METFORMIN
FILM-COATED
TABLET 500MG IS USED FOR
Royce
Metformin
Film-Coated
Tablet
500mg
is
indicated
for
a
condition
of
diabetes mellitus when dietary measures,
physical exercise and weight loss alone
are not sufficient to control blood glucose
levels.
HOW
ROYCE
METFORMIN
FILM-COATED
TABLET 500MG WORKS
Metformin
hydrochloride
is
an
antihyperglycaemic with lowering plasma
glucose
concentrations
after
eating
and
fasting.
It
does
not
stimulate
insulin
secretion and therefore does not produce
hypoglycaemia (low blood glucose).
BEFORE YOU USE ROYCE METFORMIN FILM-
COATED TABLET 500MG_ _
_-When you must not use it _
Do
not
take
Royce
Metformin
Film-
Coated Tablet 500mg:

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). _ _
_ _
Ask
your
doctor
or
pharmacist
for
advice before taking any medicine.
_-Before you start to use it: _
Risk of lactic acidosis
Royce Metformin Film-Coated Tablet
500mg may cause a very rare, but very
serious
side
effect
called
lactic
acidosis, particularly if your kidneys
are not working properly. The risk of

পণ্য বৈশিষ্ট্য

8
9
10
11
12
Revision date: 061119
METFORMIN FILM-COATED TABLET 500MG
(Metformin Hydrochloride-Oral Hypoglycaemic)
PRESENTATION:
White
to
off-white
colour,
round,
shallow
biconvex
with
single
break line on one side and plain on the other side.
CONTENT:
Each film-coated tablet contains:
Metformin Hydrochloride 500mg.
PHARMACOLOGICAL INFORMATION:
M e t f o r m i n
i s
a
b i g u a n i d e
w i t h
a n t i h y p e r g l y c a e m i c
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:
(1)
reduction
of
hepatic
glucose
production
by
inhibiting
gluconeogenesis and glycogenolysis.
(2)
in
muscle,
by
increasing
insulin
sensitivity,
improving
peripheral
glucose
uptake
and
utilization.
(3) 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 (GLUTs)
known to date.
Absorption:
After an oral dose of metformin hydrochloride tablet, maximum
plasma concentration (Cmax) is reached in approximately 2.5
hours (tmax). Absolute bioavailability of a 500mg 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.
• Inhibitors of OCT2 (such as cimetidine, dolutegravir, ranolazine,
trimethoprime,
vandetanib,
isavuconazole)
may
decrease
the
renal elimination of metformin and thus lead to an increase in
metformin plasma concentration.
• Inhibitors of both OCT1 and OCT2 (such as crizotinib, olaparib)
may alter efficacy and renal eli