Glucophage 850 mg film-coated tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Metformin Hydrochloride

Boleh didapati daripada:

Merck Serono (Ireland) Limited

Kod ATC:

A10BA; A10BA02

INN (Nama Antarabangsa):

Metformin Hydrochloride

Dos:

850 milligram(s)

Borang farmaseutikal:

Film-coated tablet

Jenis preskripsi:

Product subject to prescription which may be renewed (B)

Kawasan terapeutik:

Biguanides; metformin

Status kebenaran:

Marketed

Tarikh kebenaran:

1983-05-16

Risalah maklumat

23
PACKAGE LEAFLET: INFORMATION FOR THE USER
GLUCOPHAGE 850 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 pancreas that 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

Ciri produk

Health Products Regulatory Authority
26 September 2022
CRN00CVJ9
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glucophage 850 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 850 mg metformin hydrochloride
corresponding to 662.9 mg metformin base.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, circular, convex film-coated tablets, 13.5 mm in diameter and
6.6 mm high, engraved with GL850.
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. The maximum recommended dose of
metformin hydrochloride is 3 g daily, taken as 3 divided
doses.
If transfer from another oral antidiabetic agent is intended:
discontinue the other agent and initiate metformin at the dose
indicated above.
_Combination with insulin_
Metformin and insulin may be used in combination therapy to achieve
better blood glucose control. Metformin hydrochloride
is given at the usual starting dose of 500 mg