Glucophage SR 1000mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Metformin hydrochloride

Disponibil de la:

Merck Serono Ltd

Codul ATC:

A10BA02

INN (nume internaţional):

Metformin hydrochloride

Dozare:

1gram

Forma farmaceutică:

Modified-release tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 06010202; GTIN: 5013837321847 5013837321854

Prospect

PAGE 1
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WHAT IS IN THIS LEAFLET:
1.
What Glucophage SR is and what it is used for
2.
What you need to know before you take Glucophage SR
3.
How to take Glucophage SR
4.
Possible side effects
5.
How to store Glucophage SR
6.
Content of the pack and other information
1. WHAT GLUCOPHAGE SR IS AND WHAT IT IS USED FOR
Glucophage SR 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.
Glucophage 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.
Glucophage
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 to use it for energy or for storage for future
use. People with Type 2 diabetes do not make enough
insulin in their pancreas or their body does not respond
properly to the insulin it does make. This causes a build-
up of glucose in the blood which can cause a number of
serious long-term problems so it is important that you
continue to take your medicine, even though you may not
have any obvious symptoms. Glucophage SR makes the
body more sensitive to insulin and helps return to normal
the way your body uses glucose.
Glucophage SR is associated with either a stable body
weight or modest weight loss.
Glucophage SR Prolonged Release Tablets a

Caracteristicilor produsului

OBJECT 1
GLUCOPHAGE SR 500MG, 750MG AND 1000MG
PROLONGED RELEASE TABLETS
Summary of Product Characteristics Updated 23-May-2017 | Merck
1. Name of the medicinal product
Glucophage SR 500 mg prolonged release tablets
Glucophage SR 750 mg prolonged release tablets
Glucophage SR 1000 mg prolonged release tablets
2. Qualitative and quantitative composition
500 mg: One prolonged release tablet contains 500mg metformin
hydrochloride corresponding to 390 mg
metformin base.
750 mg: One prolonged release tablet contains 750 mg metformin
hydrochloride corresponding to 585 mg
metformin base.
1000 mg: One prolonged release tablet contains 1000 mg metformin
hydrochloride corresponding to 780
mg metformin base.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged release tablet.
500 mg: White to off-white, round, biconvex tablet, debossed on one
side with '500'.
750 mg: White capsule-shaped, biconvex tablet, debossed on one side
with '750' and on the other side
with 'Merck'.
1000 mg: White to off-white capsule-shaped, biconvex tablet, debossed
on one side with '1000' and on the
other side with 'MERCK'.
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 Glucophage SR 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
m