Product Details

Metformin 500mg Tablets Product Information

Do not take Metformin Tablets
– if you are allergic (hypersensitive) to metformin or any of the other
ingredients of this medicine (see ‘What Metformin Tablets 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 Metformin Tablets 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
Metformin Tablets 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 Metformin Tablets 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 Metformin Tablets 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 Metformin Tablets
during and for some time after the procedure. Your doctor will decide when
you must stop and when to restart your treatment with Metformin Tablets.
Metformin Tablets on its own does not cause hypoglycaemia (a blood
glucose level which is too low). However, if you take Metformin Tablets
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.
During treatment with Metformin Tablets, 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 Metformin Tablets
If you need to have an injection of a contrast medium that contain iodine
into your bloodstream, for example in the context of an X-ray or scan, you
must stop taking Metformin Tablets before or at the time of the injection.
Your doctor will decide when you must stop and when to restart your
treatment with Metformin Tablets.
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 Metformin
Tablets. 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 Metformin in your blood,
especially if you have reduced kidney function (such as verapamil,
rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprime,
vandetanib, isavuconazole, crizotinib, and olaparib).
– 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.
Metformin Tablets with alcohol
Avoid excessive alcohol intake while taking Metformin Tablets 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
Metformin Tablets 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.