Metabet SR tablets prolonged-release

Land: Armenien

Språk: engelska

Källa: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiva substanser:

metformin (metformin hydrochloride)

Tillgänglig från:

Morningside Pharmaceuticals Ltd

ATC-kod:

A10BA02

INN (International namn):

metformin (metformin hydrochloride)

Dos:

500mg

Läkemedelsform:

tablets prolonged-release

Enheter i paketet:

(28/2x14/) in blister

Receptbelagda typ:

Prescription

Bemyndigande status:

Registered

Tillstånd datum:

2019-12-03

Bipacksedel

: CTDV1 RM
1.3.1 - 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
METABET SR 500MG 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
1. WHAT METABET SR IS AND WHAT IT IS USED FOR
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 Type 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). You 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 enough to control blood glucose (sugar). Insulin is a
hormone that enable

Produktens egenskaper

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