Metabet SR 500mg tablets prolonged-release

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

metformin (metformin hydrochloride)

Available from:

Morningside Pharmaceuticals Ltd

ATC code:

A10BA02

INN (International Name):

metformin (metformin hydrochloride)

Dosage:

500mg

Pharmaceutical form:

tablets prolonged-release

Units in package:

(28/2x14/) blisters

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-10-22

Patient Information leaflet

PACKAGE
LEAFLET:
INFORMATION
FOR
THE
USER
Metabet
SR
500
mg
Prolonged
Release
Tablets
Metformin
hydrochloride
This
medicine
is
intended
for
ADULT
patients
only.
READ
ALL
OF
THIS
LEAFLET
CAREFULLY
BEFORE
YOU
START
TAKING
THIS
MEDICINE
BECAUSE
IT
CONTAINS
IMPORTANT
INFORMATION
FOR
YOU.
Keep
this
leaflet.
You
may
need
to
read
it
again.
If
you
have
any
further
questions,
ask
your
doctor
or
pharmacist.
This
medicine
has
been
prescribed
for
you
only
.
Do
not
pass
it
on
to
others.
It
may
harm
them,
even
if
their
signs
of
illness
are
the
same
as
yours.
If
you
get
any
side
effects,
talk
to
your
doctor
or
pharmacist.
This
includes
any
possible
side
effects
not
listed
in
this
leaflet.
See
section
4.
WHAT
IS
IN
THIS
LEAFLET:
1.
What
Metabet
SR
is
and
what
it
is
used
for
2.
What
you
need
to
know
before
you
take
Metabet
SR
3.
How
to
take
Metabet
SR
4.
Possible
side
effects
5.
How
to
store
Metabet
SR
6.
Contents
of
the
pack
and
other
information
Metabet
SR
500mg
prolonged
release
tablets
contain
the
active
ingredient
metformin
hydrochloride
and
belong
to
a
group
of
medicines
called
biguanides,
used
in
the
treatment
of
T
ype
2
(non-insulin
dependent)
diabetes
mellitus.
Metabet
SR
is
used
together
with
diet
and
exercise
to
lower
the
risk
of
developing
Type
2
diabetes
in
overweight
adults,
when
diet
and
exercise
alone
for
3
to
6
months
have
not
been
enough
to
control
blood
glucose
(sugar).
Yo
u
are
at
high
risk
of
developing
Type
2
diabetes
if
you
have
additional
conditions
like
high
blood
pressure,
age
above
40
years,
an
abnormal
amount
of
lipids
(fat)
in
the
blood
or
a
history
of
diabetes
during
pregnancy.
The
medicine
is
particularly
effective
if
you
are
aged
below
45
years,
are
very
overweight,
have
high
blood
glucose
levels
after
a
meal
or
developed
diabetes
during
pregnancy.
Metabet
SR
is
used
for
the
treatment
of
Type
2
diabetes
when
diet
and
exercise
changes
alone
have
not
been
enough
to
control
blood
glucose
(sugar).
Insulin
is
a
hormone
that
enables
body
tissues
to
take
glucose
from
the
blood
and
use
it
for
energy
or
for

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Metabet SR 500mg prolonged release tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release tablet contains:
Metformin hydrochloride 500 mg corresponding to 390 mg metformin base.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged release tablet .
Off-white coloured, oval, biconvex film-coated tablets plain on both
sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

Reduction in the risk or delay of the onset of type 2 diabetes
mellitus in adult,
overweight patients with IGT* and/or IFG*, and/or increased HbA1C who
are:
-
at high risk for developing overt type 2 diabetes mellitus (see
section 5.1) and
-
still progressing towards type 2 diabetes mellitus despite
implementation of
intensive lifestyle change for 3 to 6 months.
Treatment with Metabet SR/Metformin prolonged release tablets must be
based on a
risk score incorporating appropriate measures of glycaemic control and
including
evidence of high cardiovascular risk (see section 5.1).
Lifestyle modifications should be continued when metformin is
initiated, unless the
patient is unable to do so because of medical reasons.
*IGT: Impaired Glucose Tolerance; IFG: Impaired Fasting Glucose

Treatment of type 2 diabetes mellitus in adults, particularly in
overweight
patients,
when
dietary
management
and
exercise
alone
does
not
result
in
adequate glycaemic control. Metabet SR/Metformin prolonged release
tablets
may be used as monotherapy or in combination with other oral
antidiabetic
agents, or with insulin.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS WITH NORMAL RENAL FUNCTION (GFR ≥ 90 ML/MIN):
_Reduction in the risk or delay of the onset of type 2 diabetes _

Metformin should only be considered where intensive lifestyle
modifications for
3 to 6 months have not resulted in adequate glycaemic control.

The therapy should be initiated with one tablet Metabet SR/Metformin
prolonged
release tablets 500 mg once daily with t