Glucophage 1000 mg film-coated tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Metformin Hydrochloride

Tilgængelig fra:

Merck Serono (Ireland) Limited

ATC-kode:

A10BA; A10BA02

INN (International Name):

Metformin Hydrochloride

Dosering:

1000 milligram(s)

Lægemiddelform:

Film-coated tablet

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Biguanides; metformin

Autorisation status:

Marketed

Autorisation dato:

2001-11-16

Indlægsseddel

23
PACKAGE LEAFLET: INFORMATION FOR THE USER
GLUCOPHAGE 1000 MG FILM-COATED TABLETS
metformin hydrochloride
-
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. Do not pass it on to
others. It may harm them, even
if their symptoms 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 Glucophage is and what it is used for
2.
What you need to know before you take Glucophage
3.
How to take Glucophage
4.
Possible side effects
5.
How to store Glucophage
6.
Contents of the pack and other information
1.
WHAT GLUCOPHAGE IS AND WHAT IT IS USED FOR
Glucophage
contains metformin
,
a medicine to treat diabetes. It belongs to a group of medicines
called
biguanides.
Insulin is a hormone produced by the pancreasthat makes your body take
in glucose (sugar) from the
blood. Your body uses glucose to produce energy or stores it for
future use.
If you have diabetes, your pancreas does not make enough insulin or
your body is not able to use
properly the insulin it produces. This leads to a high level of
glucose in your blood. Glucophage helps
to lower your blood glucose to as normal a level as possible.
If you are an overweight adult, taking Glucophage over a long period
of time also helps to lower the
risk of complications associated with diabetes. Glucophage is
associated with either a stable body
weight or modest weight loss.
Glucophage is used to treat patients with type 2 diabetes (also called
'non-insulin dependent diabetes')
when diet and exercise alone have not been enough to control your
blood glucose levels. It is used
particularly in overweight patients.
Adults can take Glucophage on its own or together with other medicines
to treat diabetes (me

Produktets egenskaber

Health Products Regulatory Authority
26 September 2022
CRN00CVJ9
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glucophage 1000 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated 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
Film-coated tablet.
White, oval, biconvex film-coated tablets of dimensions 19 mm x 10.5
mm and 6.4 mm high with a score line on both side with
« 1000 » engraved on one side. The tablet can be divided into equal
halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of type 2 diabetes mellitus, particularly in overweight
patients, when dietary management and exercise alone does
not result in adequate glycaemic control.

In adults, Glucophage may be used as monotherapy or in combination
with other oral antidiabetic agents or with
insulin.

In children from 10 years of age and adolescents, Glucophage may be
used as monotherapy or in combination
with insulin.
A reduction of diabetic complications has been shown in overweight
type 2 diabetic adult patients treated with metformin as
first-line therapy after diet failure (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults with normal renal function (GFR≥ 90 mL/min)_
MONOTHERAPY AND COMBINATION WITH OTHER ORAL ANTIDIABETIC AGENTS:
The usual starting dose is 500 mg or 850 mg metformin hydrochloride 2
or 3 times daily given during or after meals.
After 10 to 15 days the dose should be adjusted on the basis of blood
glucose measurements. A slow increase of dose may
improve gastrointestinal tolerability.
In patients receiving a high metformin hydrochloride dose (2 to 3
grams per day), it is possible to replace two Glucophage
500 mg film-coated tablets with one Glucophage 1000 mg film-coated
tablet.
The maximum recommended dose of metformin hydrochloride is 3 g daily,
taken as 3 divided doses.
If transfer from another oral antidiab