Metabet SR 1000mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Metformin hydrochloride

זמין מ:

Actavis UK Ltd

קוד ATC:

A10BA02

INN (שם בינלאומי):

Metformin hydrochloride

כמות:

1gram

טופס פרצבטיות:

Modified-release tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 06010202; GTIN: 5012617022035 5012617022042

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
Metformin
1000 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 Metformin is and what it is used for
2.
What you need to know before you take Metformin
3.
How to take Metformin
4.
Possible side effects
5.
How to store Metformin
6.
Contents of the pack and other information
1. WHAT METFORMIN IS AND WHAT IT IS USED FOR
Metformin 1000mg prolonged release tablets called Metformin for short
throughout
the
leaflet,
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.
Metformin 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.
Metformin 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

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Metabet SR 1000 mg prolonged release tablets
Bolamyn SR 1000 mg prolonged release tablets
Metformin 1000 mg prolonged release tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release tablet contains:
Metformin hydrochloride 1000 mg corresponding to 780 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 with score
line on one side and plain on
other side.
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
/
Bolamyn
SR
/
Metformin
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 / Bolamyn SR / Metformin 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 shoul