GLUCOPHAGE 500mg powder for oral solution in sachets

Country: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ingredjent attiv:

METFORMIN HYDROCHLORIDE

Disponibbli minn:

Merck Sante S.A.S. 37 Rue Saint Romain, 69008 Lyon, France

Kodiċi ATC:

A10BA02

INN (Isem Internazzjonali):

METFORMIN HYDROCHLORIDE 500 mg

Għamla farmaċewtika:

POWDER FOR ORAL SOLUTION

Kompożizzjoni:

METFORMIN HYDROCHLORIDE 500 mg

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

DRUGS USED IN DIABETES

L-istatus ta 'awtorizzazzjoni:

Withdrawn

Data ta 'l-awtorizzazzjoni:

2013-05-14

Fuljett ta 'informazzjoni

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PACKAGE LEAFLET: INFORMATION FOR THE USER
GLUCOPHAGE 500 MG POWDER FOR ORAL SOLUTION IN SACHETS
metformin hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
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 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.
Content 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 b

Karatteristiċi tal-prodott

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
GLUCOPHAGE 500 mg powder for oral solution in sachets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 500 mg metformin hydrochloride corresponding to
390 mg metformin base.
Excipient with known effect: aspartame.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral solution.
White, odourless powder.
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 _
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.
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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
or 850 mg 2 or 3 times daily,
while insulin dosage is adjusted on the basis of blood glucose
measurements.
_Elderly _