GLUCOPHAGE 1000 Milligram Powder for Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

METFORMIN HYDROCHLORIDE

Available from:

Merck Serono Limited

INN (International Name):

METFORMIN HYDROCHLORIDE

Dosage:

1000 Milligram

Pharmaceutical form:

Powder for Oral Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

16 

PACKAGE LEAFLET 

17 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

GLUCOPHAGE 1000 MG POWDER FOR ORAL SOLUTION IN SACHETS 
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 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. 

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  

WHAT GLUCOPHAGE IS 
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. 

WHAT GLUCOPHAGE IS USED FOR 
Glucophage is used to treat patie

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glucophage 1000 mg powder for oral solution in sachets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 1000 mg metformin hydrochloride corresponding to 780 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 anti-diabetic 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. In patients receiving a high metformin hydrochloride dose (2 to 3 grams per
day), it is possible to replace two Glucophage 500 mg doses with one Glucophage 1000 mg dose.
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