Skip to Content

UK Edition. Click here for US version.

GLUCOPHAGE 500MG TABLETS

Active substance(s): METFORMIN HYDROCHLORIDE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Package leaflet: Information for the user
TW1045876/1291552
Film-coated tablets
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. 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.

that you follow your doctor’s instructions precisely.
Warnings and precautions
Risk of lactic acidosis
Glucophage may cause a very rare, but very serious side effect called
lactic acidosis, particularly if your kidneys are not working properly. The
risk of developing lactic acidosis is also increased with uncontrolled
diabetes, serious infections, prolonged fasting or alcohol intake,
dehydration (see further information below), liver problems and any
medical conditions in which a part of the body has a reduced supply of
oxygen (such as acute severe heart disease).
If any of the above apply to you, talk to your doctor for further
instructions.
Stop taking Glucophage for a short time if you have a condition
that may be associated with dehydration (significant loss of body
fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if
you drink less fluid than normal. Talk to your doctor for further
instructions.
Stop taking Glucophage and contact a doctor or the nearest
hospital immediately if you experience some of the symptoms of
lactic acidosis, as this condition may lead to coma.
Symptoms of lactic acidosis include:
• vomiting
• stomach ache (abdominal pain)
• muscle cramps
• a general feeling of not being well with severe tiredness
• difficulty in breathing
• reduced body temperature and heartbeat

2. What you need to know before you take Glucophage
Do not take Glucophage
• if you are allergic (hypersensitive) to metformin or any of the other
ingredients of this medicine (see ‘What Glucophage contains’ in section 6)
• if you have liver problems
• if you have severely reduced kidney function
• if you have uncontrolled diabetes, with, for example, severe
hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea,
rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) 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 your breath developing an unusual fruity smell
• 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').
• if you have a severe infection, such as an infection affecting your
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:
• you 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

Lactic acidosis is a medical emergency and must be treated in a
hospital.
If you need to have major surgery you must stop taking Glucophage
during and for some time after the procedure. Your doctor will decide
when you must stop and when to restart your treatment with
Glucophage.
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, vision
disorders or difficulty in concentration, it usually helps to eat or drink
something containing sugar.
During treatment with Glucophage, your doctor will check your kidney
function at least once a year or more frequently if you are elderly and/
or if you have worsening kidney function.
Other medicines and Glucophage
If you need to have an injection of a contrast medium that contains
iodine into your bloodstream, for example in the context of an X-ray
or scan, you must stop taking Glucophage before or at the time of
injection. Your doctor will decide when you must stop and when to
restart your treatment with Glucophage.
Tell your doctor if you are taking, have recently taken or might take
any other medicines. You may need more frequent blood glucose and
kidney function tests, or your doctor may need to adjust the dosage
of Glucophage. It is especially important to mention the following:
• medicines which increase urine production (diuretics).
• medicines used to treat pain and inflammation (NSAID and COX-2inhibitors, such as ibuprofen and celecoxib).
• certain medicines for the treatment of high blood pressure (ACE
inhibitors and angiotensin II receptor antagonists).
• beta-2 agonists such as salbutamol or terbutaline (used to treat
asthma).
MC-2076-2016

• corticosteroids (used to treat a variety of conditions, such as severe
inflammation of the skin or in asthma).
• medicines that may change the amount of Glucophage in your blood,
especially if you have reduced kidney function (such as verapamil,
rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprime,
vandetanib, isavuconazole, crizotinib, olaparib).
• other medicines used to treat diabetes.
Glucophage with alcohol
Avoid excessive alcohol intake while taking Glucophage since this may
increase the risk of lactic acidosis (see section ‘Warnings and precautions’).
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
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 heartbeat, 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.
If you have reduced kidney function, your doctor may prescribe a lower dose.
If you take insulin too, your doctor will tell you how to start Glucophage.
Monitoring
• Your doctor will perform regular blood glucose tests and will adapt
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.
• If you take one dose a day, take it in the morning (breakfast)
• If you take two divided doses a day, take them in the morning
(breakfast) and evening (dinner)
• If you take three divided doses a day, take them in the morning
(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 than 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
heartbeat. 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:
Glucophage may cause a very rare (may affect up to 1 user in 10,000),
but very serious side effect called lactic acidosis (see section ‘Warnings
and precautions’). If this happens you must stop taking Glucophage
and contact a doctor or the nearest hospital immediately, as lactic
acidosis may lead to coma.

Very common side effects (in more than 1 in 10 people)
• digestive 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)
• lactic acidosis. This is a very rare but serious complication particularly
if your kidneys are not working properly.
Symptoms of lactic acidosis are non-specific (see section ‘Warning
and precautions’)
• 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.
• skin reactions such as redness of the skin (erythema), itching or an
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.
• The other ingredients are povidone K 30, magnesium stearate, 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 December 2016

MC-2076-2016

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide