Product Details

What you need to know before you take Jardiance

Do not take Jardiance • if you are allergic to empagliflozin or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Contact a doctor or the nearest hospital straight away: Ketoacidosis • 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 “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 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. Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment: • if you have “type 1 diabetes”. This type usually starts when you are young and your body does not produce any insulin. You should not take Jardiance to treat your type 1 diabetes. • if you have serious kidney problems – your doctor may limit your dose to 10 mg once a day or ask you to take a different medicine (see also section 3, ‘How to take Jardiance’). • if you have serious liver problems – your doctor may ask you to take a different medicine. • 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 75 years old or older. Possible signs are listed in section 4 under ‘dehydration’. Your doctor may ask you to stop taking Jardiance until you recover to prevent loss of too much body fluid. Ask about ways to prevent dehydration. • if you have a serious infection of the kidney or the urinary tract with fever. Your doctor may ask you to stop taking Jardiance until you have recovered. 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. J2/GB/PI/8 dated 13/06/22 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. Kidney function Your kidneys should be checked before you start taking and whilst you are on this medicine. Urine glucose Because of how this medicine works, your urine will test positive for sugar while you are taking this medicine. Children and adolescents Jardiance is not recommended for children and adolescents under 18 years, because it has not been studied in these patients. Other medicines and Jardiance Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is important to tell your doctor: • if you are taking medicines that increase urine production (diuretics). Your doctor may ask you to stop taking Jardiance. Possible signs of losing too much fluid from your body are listed in section 4. • if you are taking 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). • if you are taking lithium because Jardiance can lower the amount of lithium in your blood. 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 use Jardiance if you are pregnant. It is unknown if Jardiance is harmful to the unborn child. Do not use Jardiance if you are breast-feeding. It is not known if Jardiance passes into human breast milk. Driving and using machines Jardiance 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 Jardiance. Jardiance contains lactose Jardiance contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Jardiance contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.