Metabet SR 500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Metformin hydrochloride

Available from:

Morningside Healthcare Ltd

ATC code:

A10BA02

INN (International Name):

Metformin hydrochloride

Dosage:

500mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06010202; GTIN: 5055132711190 5055132711206

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Metformin 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 Metformin 500mg Prolonged-Release Tablets are and what
they are used for
2.
What you need to know before you take Metformin 500mg
Prolonged-Release Tablets
3.
How to take Metformin 500mg Prolonged-Release Tablets
4.
Possible side effects
5.
How to store Metformin 500mg Prolonged-Release Tablets
6.
Contents of the pack and other information
1. WHAT METFORMIN 500MG PROLONGED-RELEASE TABLETS ARE AND
WHAT THEY ARE USED FOR
Metformin 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.
Metformin 500mg Prolonged-Release Tablets are 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 5

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Metabet SR 500mg prolonged release tablets
Metformin 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
prolonge