GLUCOPHAGE 1000 Milligram Film Coated Tablet

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

METFORMIN HYDROCHLORIDE

Mevcut itibaren:

Merck Serono Limited

ATC kodu:

A10BA02

INN (International Adı):

METFORMIN HYDROCHLORIDE

Doz:

1000 Milligram

Farmasötik formu:

Film Coated Tablet

Reçete türü:

Product subject to prescription which may be renewed (B)

Terapötik alanı:

Biguanides

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2010-06-04

Bilgilendirme broşürü

MC-2079-2016
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
(medicines taken by mouth or insulin).
PACKAGE LEAFLET: INFORMATION FOR THE USER
Childr

Ürün özellikleri

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 antidiabetic agent is intended:
discontinue the other agent and initiate metformin at the
dos