Product Details

What you need to know before you take Synjardy

Do not take Synjardy • if you are allergic to empagliflozin, metformin or any of the other ingredients of this medicine (listed in section 6); • if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (very 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 have had a diabetic pre-coma; • if you have serious kidney problems. Your doctor may limit your daily dose or ask you to take a different medicine (see also section 3, ‘How to take Synjardy’). • 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 lost a lot of water from your body (dehydration), e.g. 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 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 section ‘Warnings and precautions’); • if you have problems with your liver; • if you drink large amounts of alcohol, either every day or only from time to time (see section “Synjardy with alcohol”). Warnings and precautions Risk of lactic acidosis Synjardy 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 diseases). If any of the above apply to you, talk to your doctor for further instructions. Stop taking Synjardy 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 Synjardy 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. Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment: • if you experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat, contact a doctor or the nearest hospital straight away. These symptoms could be a sign of “diabetic ketoacidosis” – a rare, but serious, sometimes life-threatening problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests. The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness; • if you have “type 1 diabetes” – this type usually starts when you are young and your body does not produce any insulin. Synjardy should not be used to treat patients with type 1 diabetes; • might be at risk of dehydration, for example: o if you are being sick, have diarrhoea or fever, or if you are not able to eat or drink o if you are taking medicines that increase urine production [diuretics] or lower blood pressure o if you are over 75 years old Possible signs are listed in section 4 under ‘dehydration’. Your doctor may ask you to stop taking Synjardy until you recover to prevent loss of too much body fluid. Ask about ways to prevent dehydration. • if you are 85 years old or older as you should not start taking Synjardy due to limited therapeutic experience; • if you have a serious infection of the kidney or the urinary tract with fever. Your doctor may ask you to stop taking Synjardy until you have recovered; • if you need to undergo an examination with iodination contrast agents (such as X-ray or scan). More information is given below in “Other medicines and Synjardy”. Talk to your doctor immediately if you develop a combination of symptoms of pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the anus with fever or feeling generally unwell. These symptoms could be a sign of a rare but serious or even life-threatening infection, called necrotising fasciitis of the perineum or Fournier’s gangrene which destroys the tissue under the skin. Fournier’s gangrene has to be treated immediately. Surgery If you need to have major surgery you must stop taking Synjardy during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Synjardy. Kidney function During treatment with Synjardy, 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. Foot care Like for all diabetic patients it is important to check your feet regularly and adhere to any other advice regarding foot care given by your health care professional. Urine glucose Because of how this medicine works, your urine will test positive for sugar while you are taking this medicine. Children and adolescents This medicine is not recommended for use in children and adolescents under 18 years, because it has not been studied in these patients. Other medicines and Synjardy 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 Synjardy before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with Synjardy. 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 Synjardy. It is especially important to mention the following: • medicines which increase urine production (diuretics), as Synjardy may increase the risk of losing too much fluid. Your doctor may ask you to stop taking Synjardy. Possible signs of losing too much fluid from your body are listed in section 4. • other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine. Your doctor may want to lower the dose of these other medicines, to prevent your blood sugar levels from getting too low (hypoglycaemia). • 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, olaparib). • bronchodilators (beta-2 agonists) which are used to treat asthma. • corticosteroids (given by mouth, as an injection, or inhaled), which are used to treat inflammation in diseases like asthma and arthritis. • 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). • medicines that contain alcohol (see section ‘Synjardy with alcohol’). • iodinated contrast agents (medicines used during an X-ray, see section ‘Warnings and precautions’. • if you are taking lithium because Synjardy can lower the amount of lithium in your blood. Synjardy with alcohol Avoid excessive alcohol intake while taking Synjardy since this may increase the risk of lactic acidosis (see section ‘Warnings and precautions’). Pregnancy and breast‑feeding 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. Do not take Synjardy if you are pregnant. It is unknown if this medicine is harmful to the unborn child. Metformin passes into human milk in small amounts. It is not known whether empagliflozin passes into human breast milk. Do not take Synjardy if you are breast-feeding. Driving and using machines Synjardy has minor influence on the ability to drive and use machines. Taking this medicine in combination with medicines called sulphonylureas or with insulin can cause blood sugar levels to drop too low (hypoglycaemia), which may cause symptoms such as shaking, sweating and change in vision, and may affect your ability to drive and use machines. Do not drive or use any tools or machines if you feel dizzy while taking Synjardy