Product Details

Glucophage 500mg Tablets Product Information

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 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
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-2-inhibitors,
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).
• 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’)