GLUCOPHAGE 500MG TABLETS

Active substance: METFORMIN HYDROCHLORIDE

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Glucophage 500mg tablets UK and IRE PIL
Prepared February 2011Merck Serono Ltd
Bedfont Cross
UK

PACKAGE LEAFLET: INFORMATION FOR THE USER

IDENTIFICATION DE L’ARTICLE
Code :

532317

Type :

NOTICE

Produit :

GLUCOPHAGE

UK

DONNEES TECHNIQUES
Site de production :
SEMOY
Dimensions :
140 x 240 mm
Réf. Plans/Fiches techniques :
140x240-RV-A-01 a
Code MDA :
COULEUR(S) : 1
Référence PMS :
Black + tramé 20%, 50%, 90%
Plan technique

POLICES
Corps minimum : 7 pt
Référence(s) :
ATRotisSansSerif
Historique
Vx :

Date :

Auteur :

V1a

28/10/2009

Danièle DENIAU

V1b

03/11/2009

Vincent BROSSERON

LOGICIEL UTILISÉ :
ADOBE INDESIGN CS2
CODE(S) A BARRES
Type :

Libellé :

Code 128c

532317

UAC
(Name, job title, company, country, date & signature)

if TAKE GLUCOPHAGE
3. HOW TOyou start to feel these symptoms.
Always take Glucophage exactly as your doctor has told you. Check
with your 3. HOW TO TAKE GLUCOPHAGE
doctor or pharmacist if you are not sure.
Always take replace the benefits of doctor has lifestyle.
Glucophage cannot Glucophage exactly as youra healthy told you.
Continue Check with your doctor or pharmacist if you arehas given
to follow any advice about diet that your doctor not sure.
Glucophage cannot replace the benefits of a healthy
you and get some regular exercise.
your doctor has given you and get some regular exercise.
Usual dose
Usual dose
Children 10 years and over and adolescents usually start with 500 mg
or 850 mg Glucophage once a and The maximum daily dose is 2000
Children 10 years day. over and adolescents usually
mg taken start or 3 divided doses. Treatment of children betweenThe
as 2 with 500mg or 850mg Glucophage once a day. 10
and 12 years of age isdaily recommended on taken as 2 or from your
maximum only dose is 2000mg specific advice 3 divided
doctor, asdoses. Treatment age group isbetween 10 and 12 years of
experience in this of children limited.
Adults usually is only recommended on specific advice from three
age start with 500 mg or 850 mg Glucophage two or your
times a day. The maximum daily dose is 3000 mg is limited.3 divided
doctor, as experience in this age group taken as
doses. Adults usually start with 500mg or 850mg Glucophage
If you take insulin too,times a day.The maximum how to start
two or three your doctor will tell you daily dose is
Glucophage.
3000mg taken as 3 divided doses.

1. WHAT GLUCOPHAGE IS AND WHAT IT IS USED FOR
1. WHAT GLUCOPHAGE IS AND WHAT IT IS USED FOR
What Glucophage is
What Glucophage is
Glucophage contains metformin, medicine to treat diabetes.
Glucophage contains metformin, aa medicine to treat diabetes.
It belongs to a group of medicines called biguanides.
It belongs to a group of medicines called biguanides.
Insulin is a hormone produced by the pancreas that makes
Insulin is a hormone produced by the pancreas that makes
your body take in glucose (sugar) from the blood. Your body
your body take in glucose (sugar) from the blood. Your body
uses glucose to produce energy or stores it for future use.
uses glucose to produce energy or stores it for future use.
If you have diabetes, your pancreas does not make enough
If you have diabetes, your pancreas does not make enough
insulin or your body is not able to use properly the insulin
insulin or your body is not able to use properly the insulin it
produces. This leads to a a high level of glucose in blood.
it produces. This leads tohigh level of glucose in youryour
Glucophage helps helps to lower your blood glucose to as
blood. Glucophageto lower your blood glucose to as normal a
level as possible.
normal a level as possible.
If you are an overweight adult, taking Glucophage a long
If you are an overweight adult, taking Glucophage overover
period period also helps to helps to lower complications
a long of time of time also lower the risk of the risk of
associated with diabetes. with diabetes.
complications associatedGlucophage is associated with either
a stable body weight or modest
What Glucophage is used forweight loss.
What Glucophage used for
Glucophage is usedisto treat patients with type 2 diabetes
Glucophage is used to dependent diabetes’) when diet and
(also called ‘non-insulintreat patients with type 2 diabetes (also
called alone have dependent diabetes') when diet and
exercise 'non-insulin not been enough to control your blood
exercise alone is used particularly in overweight your blood
glucose levels. Ithave not been enough to controlpatients.
glucose levels. It Glucophage on its own or together with
Adults can take is used particularly in overweight patients.
Adults can take Glucophage on its own or together with by
other medicines to treat diabetes (medicines taken other
medicines to treat
mouth or insulin). diabetes (medicines taken by mouth or
insulin).
Children 10 years and over and adolescents can take
Children 10 years and
Glucophage on its own or over andwith insulin. can take
together adolescents
Glucophage on its own or together with insulin.

2. BEFORE YOU TAKE GLUCOPHAGE
2.
Do BEFORE YOU TAKE GLUCOPHAGE
not take Glucophage
Do
• if not take allergic (hypersensitive) to metformin or any
you are Glucophage
• if you are allergic (hypersensitive) to metformin or any of the
of the other ingredients of this medicine (see ‘What
other ingredients of this medicine (see 'What Glucophage
Glucophage contains’ in section 6)
contains' in section 6)
• if you have kidney or liver problems
• if
• if you have kidney or liver problems
you have uncontrolled diabetes, such as severe
• if you have uncontrolled diabetes, with e.g. severe
hyperglycaemia or ketoacidosis. Ketoacidosis is a
hyperglycaemia (high blood glucose), nausea, vomiting,
condition in which substances called ‘ketone bodies’
dehydration, rapid weight loss or ketoacidosis. Ketoacidosis is
accumulate in the blood. Symptoms include stomach
a condition in which substances called 'ketone bodies'
pain, fast and deep breathing, sleepiness or unusual
accumulate in the blood and which can lead to diabetic prefruity odour of the breath
coma. Symptoms include stomach pain, fast and deep
• if you lost too much water from your body (dehydration),
breathing, sleepiness or unusual fruity odour of the breath
such as due to long-lasting or severe diarrhoea, or if you
• if you lost too much water from your body (dehydration),
have vomited several times in a row. Dehydration may lead
such as due to long-lasting or severe diarrhoea, or if you have
to kidney problems, which can put you at risk for lactic
vomited several times in a row. Dehydration may lead to
acidosis (see ‘Take special care with Glucophage’ below).
kidney problems, which can put you at risk for lactic acidosis
• if you have a severe infection, such as an infection
(see 'Take special care with Glucophage' below).
affecting your lung or bronchial system or your kidney.
• if you have a severe infection, such as an infection affecting
Severe infections may lead to kidney problems, which
your lung or bronchial system or your kidney. Severe
can put you at risk for lactic acidosis (see ‘Take special
infections may lead to kidney problems, which can put you at
care with Glucophage’ below).
risk for lactic acidosis (see 'Take special care with Glucophage'
• if you are treated for heart failure or have recently had
below).
a heart attack, have severe problems with your circulation
• if you are treated for heart failure or have recently had a
or have breathing difficulties. This may lead to a lack in
heart attack, have severe problems with your circulation (such
oxygen supply to tissue which can put you at risk for lactic
as shock) or have breathing difficulties. This may lead to a lack
acidosis (see ‘Take special care with Glucophage’ below)
in oxygen supply to tissue which can put you at risk for lactic
• if you drink a lotspecial care with Glucophage' below)
of alcohol
acidosis (see 'Take
• if you drink a lot of alcohol
you are breast-feeding
• if
If any of the above applies to to you, talkyouryour doctor,
any of the above applies you, talk to to doctor, before
If
before you startthis medicine.
taking this medicine.
you start taking

Make sure you ask your doctor for advice, if
Make sure you ask your doctor for advice, if
• you need to have an examination such as as X-ray scan
have an examination such X-ray or or
• you
involving the injection of contrast medicines that contain
scan involving the injection of contrast medicines that
iodine into your bloodstream
contain iodine into your bloodstream

• you need to have major surgery
to have major surgery
You
You must stop taking Glucophage for a certain period of time
stop taking Glucophage for a certain period of
before and and the examination or the surgery. Your Your
time before after after the examination or the surgery. doctor
will decide whether you need need any other treatment
doctor will decide whether youany other treatment for this
time. It time. It is important that you follow your doctor’s
for this is important that you follow your doctor's instructions
precisely.
instructions precisely.
Take special care with Glucophage
Take special care with Glucophage
Please note may following particular seriouslactic acidosis.
Glucophage the followingvery rare, but risklactic acidosis.
Please note the cause a particular risk of of complication
Glucophage may cause a very rare,ifbut serious complication
Glucophage may cause a very rare, your kidneys are not
called lactic acidosis, particularly but serious complication
called lactic acidosis, particularly if your kidneys are not
called properly. Symptoms of lactic your kidneys are not
workinglactic acidosis, particularly if acidosis are vomiting,
working properly. The risk of lactic acidosis is also increased
working (abdominal risk with muscle cramps, general
bellyacheproperly. Thepain)of lactic acidosis is alsoaincreased
with uncontrolled diabetes, prolonged fasting or alcohol
with of not being diabetes, prolonged fasting difficulty
feelinguncontrolled well with severe tiredness, andor alcohol
intake. Symptoms of lactic acidosis are vomiting, bellyache
intake. Symptoms of lactic acidosis are vomiting, bellyache
in breathing.
(abdominal pain) with muscleyou may general feeling of not
(abdominal pain) to muscle cramps, need immediate
If this happens with you, cramps, a a general feeling of
beingbeingwith severe severe and difficulty breathing. If
not well well taking Glucophage immediately and
treatment. Stop with tiredness,tiredness, andin difficulty in
this your doctor straight away. need immediate hospital
breathing. If this happens to
tell happens to you, you may you, you may need
treatment, hospitalown does not cause hypoglycaemia
immediate lactic treatment, lead to coma. Stop taking
Glucophageason its acidosis mayas lactic acidosis may lead
Glucophage Stop takingand contact a doctor or the nearest
to coma. immediately is too low). However, if you and
(a blood glucose level whichGlucophage immediately take
hospital straight away.
contact a doctor or with other hospital to treat diabetes
Glucophage togetherthe nearestmedicinesstraight away.
that can cause hypoglycaemia (such as sulphonylureas,
Glucophage on its own does not cause hypoglycaemia (a
insulin, glinides), there is a risk of hypoglycaemia. If you
blood glucose level which is too low). However, if you take
experience symptoms with other medicines to as weakness,
of hypoglycaemia such treat diabetes
Glucophage together
dizziness, increased sweating, fast heart beating, vision
that can cause hypoglycaemia (such as sulphonylureas,
disorders or difficulty there is a risk of hypoglycaemia. If you
in concentration, it usually helps to
insulin, meglitinides),
eat or drink symptoms of hypoglycaemia such as weakness,
experience something containing sugar.
Taking other medicines
dizziness, increased sweating, fast heart beating, visions
If you need difficulty in concentration, it usually helps to eat
disorders or to have an injection of contrast medicines
that contain iodine into your bloodstream, for example
or drink something containing sugar.
for examinations such as X-ray or scan, you must stop
Taking other medicines
takingneed to have forinjection ofperiod ofmedicines that
If you Glucophage an a certain contrast time before
and after the examinationbloodstream, foryou ask your
contain iodine into your (see ‘Make sure example for
doctor for advice’ above). or scan, you must stop taking
examinations such as X-ray
Tell your doctor ifayou take period thetime before and after
Glucophage for certain any of of following medicines
and examination at(see 'Make sure you ask your doctor for
the same time. You may need more
the Glucophage
frequent blood glucose tests or your doctor may adjust
advice' above).
the dosage of Glucophage: any of the following medicines
Tell your doctor if you take
• angiotensin-convertingsame time. You may need treat
and Glucophage at the enzyme inhibitors (used to more
a variety of heart and blood your conditions, such the
frequent blood glucose tests or vesseldoctor may adjust as
high of Glucophage:
dosageblood pressure or heart failure)
• diuretics (used to remove water from the body by making
• diuretics (used to remove water from the body by making
more urine).
more urine).
• beta-2 agonists such as salbutamol or terbutaline (used to
• beta-2 agonists such as salbutamol or terbutaline (used
to asthma)
treattreat asthma)
• corticosteroids(used toto treat a variety of conditions,
• corticosteroids (used treat a variety of conditions, such as
such as severe inflammation of the skin or
severe inflammation of the skin or in asthma) in asthma)
Please tell your doctor or pharmacist if you are taking
• other medicines used to treat diabetes
Please tell your doctor or any other you are taking or have
or have recently taken pharmacist ifmedicines, including
recently taken any other medicines, including medicines
medicines obtained without a prescription.
obtained without a prescription.
Taking Glucophage with food and drink
Taking Glucophage when you take this
Do not drink alcohol with food and drinkmedicine. Alcohol
Do increase the risk of lactic take this medicine. Alcohol
maynot drink alcohol when you acidosis especially if you
may liver problems or if you acidosis especially you have
have increase the risk of lacticare undernourished.ifThis also
liver problems or if you are undernourished.
applies to medicines that contain alcohol. This also applies
to medicines that contain alcohol.
Pregnancy and breast-feeding
Pregnancy and breast-feeding
During pregnancy, you need insulin to treat your diabetes.
During pregnancy, you are, insulin to you might be or
Tell your doctor if you need you think treat your diabetes.
Tell your doctor if you pregnant, so you he or be may
are planning to becomeare, you think that might she or are
planning to treatment.
change yourbecome pregnant, so that he or she may change
your treatment. medicine if you are breast-feeding or if
Do not take this
This medicine is to recommended if baby.
you are planningnot breast-feed your you are breast-feeding
or if you are planning to breast-feed your baby.

lifestyle. Continue to follow any advice about diet that

âTA1ìëîä

84 cps

Pays

difficulty in concentration. Do not drive or use machines

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. Do not pass it on to others. It may harm them, even if their symptoms are
the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1. What Glucophage is and what it is used for
2. Before you take Glucophage
3. How to take Glucophage
4. Possible side effects
5. How to store Glucophage
6. Further information

500 mg

Présentat° :

TW232634

Metformin hydrochloride

âTA1ìëîä

Dosage :

Film-coated tablets

Driving and usingand using machines
Driving machines
Glucophage on its own doesown does not cause hypoglycaemia
Glucophage on its not cause hypoglycaemia (a blood
glucose level which is too low). This means that it will not affect your
(a blood glucose level which is too low). This means that it
ability to drivenotuse machines.
will or affect your ability to drive or use machines.
However, However, take special care if you take Glucophage together
take special care if you take Glucophage together with other
medicineswithtreat diabetes that to treat diabetes that can cause
to other medicines can cause hypoglycaemia (such as
sulphonylureas, insulin, meglitinides). Symptoms of hypoglycaemia
hypoglycaemia (such as sulphonylureas, insulin, glinides).
include weakness, dizziness, increased sweating, fast heart beat, vision
Symptoms of hypoglycaemia include weakness, dizziness,
disorders or difficulty in concentration. Do not drive or use machines if
increased sweating, fast heart beat, vision disorders or
you start to feel these symptoms.

If you take insulin too, your doctor will tell you how to

Monitoring
start Glucophage.
Your doctor will perform regular blood glucose tests and will adapt
Monitoring
your dose of Glucophage to your blood glucose levels. Make sure that
• Your doctor will adapt your dose of Glucophage to
you talk to your doctor regularly. This is particularly important for
your blood or if you are an Make sure that you talk to
children and adolescentsglucose levels. older person.
Your doctoryouralso check at least once is year how well your kidneys
will doctor regularly. This a particularly important for
children more frequent checks if you are an older person
work. You may need and adolescents or if you are an older person.
• Your are not working normally.at least once a year how
or if your kidneys doctor will also check

well your kidneys work. You may need more frequent

checks if you
How to take Glucophage are an older person or if your kidneys are
not working after a meal. This will avoid you having side
Take Glucophage with ornormally.
How your digestion.
effects affectingto take Glucophage
Take the tablets with or after a meal. This with a glass of
Do not crush or chew the tablets. Swallow each tablet will avoid you
water.
having side effects affecting your digestion.
• If you take one dose a day, take it in the morning (breakfast) tablet
Do not crush or chew the tablets. Swallow each
• If you take two divided doses a day, take them in the morning
with a glass of water.
(breakfast) andyou take(dinner)
• If evening one dose a day, take it in the morning
• If you take(breakfast) doses a day, take them in the morning
three divided
(breakfast), at noontake two divided evening (dinner) them in the
• If you (lunch) and in the doses a day, take
If, after some time, you think that the effect(dinner)
morning (breakfast) and evening of Glucophage is too
strong or too weak,take to your doctor or pharmacist.take them in the
• If you talk three divided doses a day,
morning (breakfast), at noon (lunch) and in the evening

If you take more Glucophage than you should
(dinner)
If you have taken more Glucophage that you should have, you may
If, after some time, you think that the effect of Glucophage
experience lactic acidosis. Symptoms of lactic acidosis are vomiting,
is too strong or too weak, talk to your doctor or pharmacist.
bellyache (abdominal pain) with muscle cramps, a general feeling of
If you take more Glucophage than you should
not being well with severe tiredness, and difficulty in breathing. If this
If you have taken more Glucophage than you should have,
happens to you, you may need immediate hospital treatment, as lactic
you may experience lactic acidosis. the nearest hospital
acidosis may lead to coma. Contact a doctor or Symptoms of lactic
acidosis are vomiting, bellyache (abdominal pain) with
straight away.
muscle cramps, a general
If you forget to take Glucophage feeling of not being well with
severe tiredness, and difficulty a breathing. Talk to the
Do not take a double dose to make up for inforgotten dose. Takeyour
next dosedoctorusual time.
at the or pharmacist straight away.
If you forget to take Glucophage
If you have any further questions on the use of this product, ask your
Do not take
doctor or pharmacist. a double dose to make up for a forgotten

dose. Take the next dose at the usual time.
If SIDE EFFECTS
4. POSSIBLEyou have any further questions on the use of this
Like all medicines, ask your doctor or pharmacist.
product, Glucophage can cause side effects, although not
everybody gets them. The following side effects may occur:
4. POSSIBLE SIDE EFFECTS
Very common all medicines, more than 1 in 10 cause side effects,
Like side effects (in Glucophage can people)
• Digestive problems, such as feeling them.(nausea), being side
although not everybody gets sick The following sick
(vomiting), diarrhoea, bellyache (abdominal pain) and loss of appetite.
effects may occur:
These side effects most often happenmore than 1 in 10 people)
Very common side effects (in at the beginning of the
treatment•with Glucophage. It helps ifas feeling sick (nausea), being
digestive problems, such you spread the doses over the
day and if sick (vomiting), diarrhoea, bellyache (abdominalapain) and
you take Glucophage with or straight after meal. If
symptoms continue, stop taking Glucophage and talk to your
loss of appetite.
doctor.

These side effects most often happen at the beginning
of the treatment with Glucophage. It helps if you spread
Common side effects (in less than 1 in 10 people)
the doses over the day and if you take the tablets with
• changes in taste.
or straight after a meal.
If symptoms continue, stop taking Glucophage and
talk to your doctor.

Very rare side effects (in less than 1 10,000 people)
Common side effects (in less than 1 in in 10 people)
• lactic acidosis. This is a very rare but serious complication
• changes in taste.
particularly if your kidneys less than 1 in properly.
Very rare side effects (in are not working 10,000 people)
Symptoms of lactic is a very rare but serious complication
• lactic acidosis. Thisacidosis are vomiting, bellyache (abdominal
pain) with muscle cramps, a general feeling of not being well
particularly if your kidneys are not working properly.
with severe tiredness, and difficulty in will need immediate
If you get this complication, you breathing. If this happens
to you, you may need immediate hospital treatment, as lactic
treatment. Symptoms of lactic acidosis are vomiting,
acidosis may lead to pain) with muscle cramps, a
bellyache (abdominal coma. Stop taking Glucophage
immediately and contact a doctor or severe tiredness,
general feeling of not being well with the nearest hospital
straight away.
and difficulty in breathing. If this happens to you, stop
• abnormalities in liver function tests or hepatitis (inflammation
taking Glucophage immediately and tell your doctor
of the liver; this may cause tiredness, loss of appetite, weight loss,
straight away.
with or without yellowing of the skin or whites of the eyes). If this
• skin reactions such as redness of the skin (erythema),
happens to you, stop taking Glucophage and talk to your
itching or an itchy rash (urticaria).
doctor.
in the blood.
• low vitamin B12 levels redness of the skin (erythema), itching or
• skin reactions such as
Theitchy rash (hives). the following side effects are not
frequencies of
an
known:
• low vitamin B12 levels in the blood.
• abnormalities in liver function tests or hepatitis
(inflammation of the liver;
Children and adolescents this may cause tiredness, loss
of appetite, weight loss, with or without yellowing of
Limited data in children and adolescents showed that adverse
the skin or whites of the eyes). severity to those reported
events were similar in nature and If this happens to you, in
stop
adults. taking this medicine.
Children and adolescents
Limitedofdata sidechildren gets serious, or if you noticethat side
If any
the in effects and adolescents showed any
adverse events werein this in nature and severity to those or
effects not listed similar leaflet, please tell your doctor
reported in adults.
pharmacist.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
5. HOW TO STORE GLUCOPHAGE
or pharmacist. reach and sight of children. If a child is treated
Keep out of the
with Glucophage, parents and caregivers are advised to oversee
how this TO STORE GLUCOPHAGE
5. HOW medicine is used.
This medicinal reach does not require any a child is
Keep out of the productand sight of children. If special storage
conditions.
treated with Glucophage, parents and caregivers are
Do not to oversee how after the expiry used.
advised use Glucophage this medicine is date which is stated on
the medicinal bottle the not after 'EXP'. The expiry
This carton or theproductordoesblister require any special date
refers to the last day
storage conditions. of that month.
Medicines Glucophage after the expiry via which is
Do not use should not be disposed of date wastewater or
household waste. or your pharmacist how to ‘EXP’.
stated on the cartonAsk the bottle or the blister afterdispose of
medicines no refers required. These measures will
The expiry date longer to the last day of that month. help to
protect theshould not be disposed of via wastewater or
Medicines environment.
household waste. Ask your pharmacist how to dispose of
6. FURTHER
medicines no INFORMATION These measures will help to
longer required.
What Glucophage contains
protect the environment.

The active substance is metformin hydrochloride. One filmcoated tablet of Glucophage 500 mg contains 500 mg metformin

6. FURTHER INFORMATION 390 mg metformin base.
hydrochloride corresponding to
What Glucophage contains
The other ingredients are povidone K 30, magnesium stearate,
• The active substance is metformin hydrochloride.
hypromellose.
One film-coated tablet of Glucophage 500mg contains
500mg metformin hydrochloride corresponding
What Glucophage looks like and contents of the pack to
390mg metformin film-coated tablets are white, circular and
Glucophage 500 mg base.
• The other ingredients are povidone K 30, magnesium
convex.
stearate, are supplied in
The tabletshypromellose. blister packs of 1 (x100), 9, 20, 21, 30,
What Glucophage looks like and contents 1000 tablets and in
40, 50, 56, 60, 84, 90, 100, 120, 200, 500, 600 or of the pack
Glucophage 500mg child-resistant caps of 21, 30, 40, 50, 60, 100,
plastic bottles with film-coated tablets are white, circular
and convex. 500, 600 or 1000 tablets.
120, 300, 400,
The tablets are supplied in blister packs of 1 (x100), 9, 20,
Not all pack sizes may be marketed.
21, 30, 40, 50, 56, 60, 84, 90, 100, 120, 200, 500, 600 or
1000 tablets and in plastic bottles ofManufacturer 60,
Marketing Authorisation Holder and 21, 30, 40, 50,
100, 120, 300, 400, 500, 600 or 1000 tablets.
Merck Serono Limited
Bedfont Cross, Stanwell Road
Not all pack sizes may be marketed.
Feltham, Middlesex
TW14 8NX
Marketing Authorisation Holder and Manufacturer
United Kingdom
Marketing Authorisation Holder
Merck Serono Limited
Manufacturer
Bedfont Cross, Stanwell Road
Merck Santé s.a.s.
Feltham, Middlesex
2 rue 8NX
TW14 du Pressoir Vert
45400 Kingdom
United Semoy
France

MANUFACTURER
This medicinal product is authorised in the Member States of the
Merck Santé s.a.s.
EEA
2 rueunder the following names:
du Pressoir Vert
45400 Semoy - France

Dianben: Spain
Glucophage: Austria, Belgium, Bulgaria, Cyprus, Czech Republic,

This medicinal product is authorised in Ireland, Italy, Latvia,
the Member
Finland, France, Germany, Greece, Iceland,
States of theMalta,under the following names:
EEA Norway, Poland, Portugal, Romania, Slovak
Luxembourg,
Glucophage: Austria, Belgium, Denmark, Finland, France,
Republic, Slovenia, Sweden, United Kingdom
Germany, Iceland, Ireland, Italy, Luxembourg, Netherlands,
Merckformin: Hungary
Norway, Portugal, Sweden, United Kingdom
This leaflet was last approved in 10/2010.

This leaflet was last approved in December 2009. 532317

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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