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What you need to know before you take Metformin Tablets

Do not take Metformin Tablets • if you are allergic (hypersensitive) to metformin or any of the other ingredients of this medicine (listed in section 6). • if you have liver problems • 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 have severely reduced kidney function. • if you have uncontrolled diabetes, with, for example, severe hyperglycemia (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 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 Talk to your doctor or pharmacist before taking Metformin Tablets. 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 region of the body has a reduced supply of oxygen (such as acute severe heart diseases). If any of the above applies to you, talk to your doctor for further instructions. Lactic acidosis is a medical emergency and must be treated in a hospital. 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. 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 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. Other medicines and Metformin Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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 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. 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) 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 Tablets 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 • 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) Metformin Tablets with food, drink and alcohol Avoid excessive alcohol intake while taking Metformin Tablets since this may increase the risk of lactic acidosis (see section “Warnings and precautions”). Pregnancy, breast- feeding and fertility During pregnancy, you need insulin to treat your diabetes. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 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. However, take special care if you take Metformin Tablets 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.