Product Details

Gluconorm SR 1000mg Tablets Product Information

Do not take Gluconorm SR 1000mg Tablets if
• you are allergic to metformin or to any of the other ingredients of this medicine
listed in section 6). An allergic reaction may cause a rash, itching or shortness of
breath.
• you have liver problems
• you have severely reduced kidney function
• 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.
• you have lost too much water from your body (dehydration). Dehydration may
lead to kidney problems, which can put you at risk for lactic acidosis (see
‘Warnings and precautions’).
• 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’).
• you have been treated for acute heart problems or have recently had a heart attack
or have severe circulatory problems or 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’).
• you are a heavy drinker of alcohol.
• you are under 18 years of age.
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.
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.
If you are older than 75 years, treatment with Metformin tablets should not be started to
lower the risk of developing type 2 diabetes.
You should continue to follow any dietary advice that your doctor has given you and you
should make sure that you eat carbohydrates regularly throughout the day.
Do not stop taking this medicine without speaking to your doctor.
Other medicines and Metformin tablets
If you need to have an injection of a contrast medium that contains iodine into your
bloodstream, in the context of an X-ray or scan, you must stop taking Metformin tablets
before or at the time of 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 (water tablets) such as
furosemide).
• 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)
• Steroids such as prednisolone, mometasone, beclometasone.
• Sympathomimetic medicines including epinephrine and dopamine used to treat
heart attacks and low blood pressure. Epinephrine is also included in some dental
anaesthetics.
• 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, trimethoprim, vandetanib, isavuconazole, crizotinib,
olaparib).
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’).
Fertility, pregnancy and breast-feeding
Do not take Metformin tablets if you are pregnant or breast feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Metformin tablets taken on its own does not cause ‘hypos’ (symptoms of low blood sugar or hypoglycaemia, such as faintness, confusion and increased sweating) and therefore should not affect your ability to drive or use machinery.
You should be aware, however, that Metformin tablets taken with other antidiabetic
medicines can cause hypos, so in this case you should take extra care when driving or operating machinery.