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GLUCOPHAGE 500MG TABLETS

Active substance(s): METFORMIN HYDROCHLORIDE

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Package leaflet: Information for the user
TW671901/617866/803460

Film-coated tablets

Metformin hydrochloride
Read all of this leaflet carefully before you start taking this medicine.

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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).
Children 10 years and over and adolescents can take Glucophage on
its own or together with insulin.
2. What you need to know before you take Glucophage
Do not take Glucophage
• f you are allergic (hypersensitive) to metformin or any of the other
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ingredients of this medicine (see ‘What Glucophage contains’ in
section 6)
• if you have liver problems or kidney problems (glomerular
filtration rate below 45 ml/min)
• f you have uncontrolled diabetes, with e.g. severe hyperglycaemia
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(high blood glucose), nausea, vomiting, dehydration, rapid weight
loss or ketoacidosis. Ketoacidosis is a condition in which substances
called ‘ketone bodies’ accumulate in the blood and which can lead to
diabetic pre-coma. Symptoms include stomach pain, fast and deep
breathing, sleepiness or unusual fruity odour of the breath.
• if you lost too much water from your body (dehydration), such as due
to long-lasting or severe diarrhoea, or if you have vomited several
times in a row. Dehydration may lead to kidney problems, which can
put you at risk for lactic acidosis (see 'Warnings and precautions').
• f you have a severe infection, such as an infection affecting your
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lung or bronchial system or your kidney. Severe infections may lead
to kidney problems, which can put you at risk for lactic acidosis (see
'Warnings and precautions').
• if you are treated for acute heart failure or have recently had a heart
attack, have severe problems with your circulation (such as shock) or
have breathing difficulties. This may lead to a lack in oxygen supply
to tissue which can put you at risk for lactic acidosis (see 'Warnings
and precautions').
• if you drink a lot of alcohol
If any of the above applies to you, talk to your doctor, before you start
taking this medicine.
Make sure you ask your doctor for advice, if:
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•  ou need to have an examination such as X-ray or scan involving
the injection of contrast medicines that contain iodine into your
bloodstream
• you need to have major surgery

You must stop taking Glucophage for a certain period of time before
and after the examination or the surgery. Your doctor will decide
whether you need any other treatment for this time. It is important
that you follow your doctor’s instructions precisely.
Warnings and precautions
Please note the following particular risk of lactic acidosis.
Glucophage may cause a very rare, but very serious complication
called lactic acidosis, particularly if your kidneys are not working
properly. The risk of developing lactic acidosis is also increased with
uncontrolled diabetes, prolonged fasting or alcohol intake, body
fluid deficit (dehydration) due to severe diarrhoea or vomiting,
liver problems and any medical conditions in which a region of
the body is deprived with a lack of oxygen supply (such as acute
severe heart diseases).
It is important to you to comply with your medication intake, dietary
instructions and regular exercise program because this can reduce
the risk of lactic acidosis.
The onset of lactic acidosis can be subtle and the symptoms can
be non-specific such as vomiting, bellyache (abdominal pain) with
muscle cramps, a general feeling of not being well with severe
tiredness, and difficulty in breathing. Further symptoms are reduced
body temperature and heart beat. If you experience some of these
symptoms, you should seek immediately medical attention,
as lactic acidosis may lead to coma. Stop taking Glucophage
immediately and contact a doctor or the nearest hospital
straight away.
Glucophage on its own does not cause hypoglycaemia (a blood glucose
level which is too low). However, if you take Glucophage together
with other medicines to treat diabetes that can cause hypoglycaemia
(such as sulphonylureas, insulin, meglitinides), there is a risk of
hypoglycaemia. If you experience symptoms of hypoglycaemia such
as weakness, dizziness, increased sweating, fast heart beating, visions
disorders or difficulty in concentration, it usually helps to eat or drink
something containing sugar.
Other medicines and Glucophage
If you need to have an injection of contrast medicines that contain
iodine into your bloodstream, for example for examinations such as
X-ray or scan, you must stop taking Glucophage for a certain period
of time before and after (at least 48h) the examination (see ‘Make
sure you ask your doctor for advice’ above).
Tell your doctor if you take any of the following medicines and
Glucophage at the same time. You may need more frequent blood
glucose tests or your doctor may adjust the dosage of Glucophage:
• diuretics (used to remove water from the body by making more urine).
•  eta-2 agonists such as salbutamol or terbutaline (used to treat
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asthma)
•  orticosteroids (used to treat a variety of conditions, such as severe
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inflammation of the skin or in asthma)
• other medicines used to treat diabetes
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Glucophage with food and drink
Do not drink alcohol when you take this medicine. Alcohol may increase
the risk of lactic acidosis especially if you have liver problems or if you
are undernourished. This also applies to medicines that contain alcohol.
Pregnancy and breast-feeding
During pregnancy, you need insulin to treat your diabetes. Tell your
doctor if you are, you think you might be or are planning to become
pregnant, so that he or she may change your treatment.
This medicine is not recommended if you are breast-feeding or if you
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are planning to breast-feed your baby.

Driving and using machines
Glucophage on its own does not cause hypoglycaemia (a blood glucose
level which is too low). This means that it will not affect your ability
to drive or use machines.
However, take special care if you take Glucophage together with other
medicines to treat diabetes that can cause hypoglycaemia (such as
sulphonylureas, insulin, meglitinides). Symptoms of hypoglycaemia
include weakness, dizziness, increased sweating, fast heart beat, vision
disorders or difficulty in concentration. Do not drive or use machines
if you start to feel these symptoms.
3. How to take Glucophage
Always take Glucophage exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
Glucophage cannot replace the benefits of a healthy lifestyle. Continue
to follow any advice about diet that your doctor has given you and
get some regular exercise.
Recommended dose
Children 10 years and over and adolescents usually start with 500 mg
or 850 mg Glucophage once a day. The maximum daily dose is 2000 mg
taken as 2 or 3 divided doses. Treatment of children between 10 and 12
years of age is only recommended on specific advice from your doctor,
as experience in this age group is limited.
Adults usually start with 500 mg or 850 mg Glucophage two or three
times a day. The maximum daily dose is 3000 mg taken as 3 divided
doses.
In renal impaired patients with a GFR between 45 and 60 ml/min,
the starting dose is 500 mg or 850 mg Glucophage, once daily. The
maximum dose is 1000 mg daily, given as 2 divided doses. The renal
function should be closely monitored (every 3 - 6 months).
If you take insulin too, your doctor will tell you how to start Glucophage.
Monitoring
•  our doctor will perform regular blood glucose tests and will adapt
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your dose of Glucophage to your blood glucose levels. Make sure
that you talk to your doctor regularly. This is particularly important
for children and adolescents or if you are an older person.
• Your doctor will also check at least once a year how well your kidneys
work. You may need more frequent checks if you are an older person
or if your kidneys are not working normally.
How to take Glucophage
Take Glucophage with or after a meal. This will avoid you having side
effects affecting your digestion.
Do not crush or chew the tablets. Swallow each tablet with a glass
of water.
• f you take one dose a day, take it in the morning (breakfast)
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• f you take two divided doses a day, take them in the morning
(breakfast) and evening (dinner)
• f you take three divided doses a day, take them in the morning
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(breakfast), at noon (lunch) and in the evening (dinner)
If, after some time, you think that the effect of Glucophage is too
strong or too weak, talk to your doctor or pharmacist.
If you take more Glucophage than you should
If you have taken more Glucophage that you should have, you may
experience lactic acidosis. Symptoms of lactic acidosis are non-specific
such as vomiting, bellyache (abdominal pain) with muscle cramps, a
general feeling of not being well with severe tiredness, and difficulty
in breathing. Further symptoms are reduced body temperature and
heart beat. If you experience some of these symptoms, you should
seek immediately medical attention, as lactic acidosis may lead to
coma. Stop taking Glucophage immediately and contact a doctor
or the nearest hospital straight away.
If you forget to take Glucophage
Do not take a double dose to make up for a forgotten dose. Take the
next dose at the usual time.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4. Possible side effects
Like all medicines, Glucophage can cause side effects, although not
everybody gets them. The following side effects may occur:
Very common side effects (in more than 1 in 10 people)
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•  igestive problems, such as feeling sick (nausea), being sick (vomiting),
diarrhoea, bellyache (abdominal pain) and loss of appetite. These side
effects most often happen at the beginning of the treatment with
Glucophage. It helps if you spread the doses over the day and if you
take Glucophage with or straight after a meal. If symptoms continue,
stop taking Glucophage and talk to your doctor.
Common side effects (in less than 1 in 10 people)
• changes in taste.
Very rare side effects (in less than 1 in 10,000 people)
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• actic acidosis. This is a very rare but serious complication particularly
if your kidneys are not working properly.

Symptoms of lactic acidosis are non-specific such as vomiting,
bellyache (abdominal pain) with muscle cramps, a general feeling
of not being well with severe tiredness, and difficulty in breathing.
Further symptoms are reduced body temperature and heart beat.
If you experience some of these symptoms, you should seek
immediately medical attention, as lactic acidosis may lead to
coma. Stop taking Glucophage immediately and contact a
doctor or the nearest hospital straight away.
• abnormalities in liver function tests or hepatitis (inflammation of the
liver; this may cause tiredness, loss of appetite, weight loss, with or
without yellowing of the skin or whites of the eyes). If this happens
to you, stop taking Glucophage and talk to your doctor.
•  kin reactions such as redness of the skin (erythema), itching or an
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itchy rash (hives).
• low vitamin B12 levels in the blood.
Children and adolescents
Limited data in children and adolescents showed that adverse events
were similar in nature and severity to those reported in adults.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie,
e-mail: medsafety@hpra.ie
United Kingdom
Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Glucophage
Keep out of the sight and reach of children. If a child is treated with
Glucophage, parents and caregivers are advised to oversee how this
medicine is used.
This medicinal product does not require any special storage conditions.
Do not use Glucophage after the expiry date which is stated on the
carton or the bottle or the blister after ‘EXP’. The expiry date refers to
the last day of that month.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Glucophage contains
• The active substance is metformin hydrochloride.

One film-coated tablet of Glucophage 500  mg contains 500  mg
metformin hydrochloride corresponding to 390 mg metformin base.
•  he other ingredients are povidone K 30, magnesium stearate,
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hypromellose.
What Glucophage looks like and contents of the pack
Glucophage 500 mg film-coated tablets are white, circular, 11 mm in
diameter and 5.7 mm high, convex, engraved with GL 500. The tablets
are supplied in blister packs of 1 (x100), 9, 20, 21, 30, 40, 50, 56, 60,
84, 90, 100, 120, 200, 500, 600 or 1000 tablets and in plastic bottles
with child-resistant caps of 21, 30, 40, 50, 60, 100, 120, 300, 400, 500,
600 or 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Merck Serono Limited
Bedfont Cross, Stanwell Road
Feltham, Middlesex
TW14 8NX
United Kingdom
Manufacturer
Merck S.L.
Poligono Merck
Mollet Del Vallès 08100 Barcelona
Spain
This medicinal product is authorised in the Member States of the
EEA under the following names:
Glucophage: Austria, Belgium, Bulgaria, Cyprus, Czech Republic,
Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia,
Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovakia,
Slovenia, Sweden, United Kingdom
Merckformin: Hungary
This leaflet was last approved in January 2015.

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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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