Do not take EMPAGLIFLOZIN ZYDUS:
- • if you are allergic to empagliflozin or any of the other ingredients of EMPAGLIFLOZIN ZYDUS (listed in section 6)
- • if you have type I diabetes (high sugar levels in your blood)
- • If you have increased levels of ketone bodies in your urine of blood (see Take special care with EMPAGLIFLOZIN ZYDUS)
- • if you have severe kidney problems, or have kidney failure and are on kidney dialysis
- • if you are pregnant or are breastfeeding your baby.
Warnings and precautions
Take special care with EMPAGLIFLOZIN ZYDUS Talk to your doctor, pharmacist or nurse before taking EMPAGLIFLOZIN ZYDUS, and during treatment with EMPAGLIFLOZIN ZYDUS 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 your doctor or the nearest hospital immediately. 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, or if you have or have had problems with your pancreas including pancreatitis or surgery on your pancreas. Ketoacidosis is a serious problem which is life-threatening and needs to be treated in a hospital. It has been reported in people taking EMPAGLIFLOZIN ZYDUS, regardless of blood sugar level. Stop taking EMPAGLIFLOZIN ZYDUS and contact your doctor or the nearest hospital immediately.
- • are taking or using any other medicines to lower your blood sugar, including other diabetic medicine known as a sulphonylurea, or if you are injecting insulin. Your doctor may want to reduce the dose of the sulphonylurea or insulin when you take it in combination with EMPAGLIFLOZIN ZYDUS in order to avoid low blood sugar (hypoglycaemia). Please refer to possible signs of low blood sugar listed in section 4.
- • have serious kidney problems – your doctor may prescribe you a different medicine. Your kidney function should be assessed before you start taking EMPAGLIFLOZIN ZYDUS, at least 6 monthly during treatment, and if you are taking EMPAGLIFLOZIN ZYDUS together with metformin (another medicine used to control your blood sugar).
- • have liver problems.
- • are 75 years old or older, or have problems with low blood pressure or if you are taking medicine to treat high blood pressure and/or diuretics (medicine used to remove water from the body also known as “water tablets”) as increased passing of urine due to the medicine may affect the fluid balance in your body and increase your risk of dehydration.
- • are sick or if you have diarrhoea or fever or if you are not able to eat or drink. These can cause dehydration (excessive loss of body fluid). To prevent the excessive loss of body fluid, your doctor may ask you to stop taking EMPAGLIFLOZIN ZYDUS until you have recovered.
- • are 85 years old or older as you should not start taking EMPAGLIFLOZIN ZYDUS
- • have a history of urinary tract infections or have a serious infection of the kidneys or urine. Your doctor may ask you to stop taking EMPAGLIFLOZIN ZYDUS 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.
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 provider.
Urine glucose
Because of how EMPAGLIFLOZIN ZYDUS works, your urine will test positive for sugar while you are taking EMPAGLIFLOZIN ZYDUS.
Children and adolescents
EMPAGLIFLOZIN ZYDUS is not recommended for children and adolescents under 18 years of age, because it has not been studied in these patients.
Other medicines and EMPAGLIFLOZIN ZYDUS
Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines). The following medicine may cause an interaction when taking in combination with EMPAGLIFLOZIN ZYDUS:
- • medicines used to remove water from your body (diuretics, also called “water tablets”). Your doctor may ask you to stop taking EMPAGLIFLOZIN ZYDUS. Possible signs of losing too much fluid from your body are listed in section 4.
- • 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).
EMPAGLIFLOZIN ZYDUS with food and drink You can take EMPAGLIFLOZIN ZYDUS with or without food.
Pregnancy and breastfeeding
Do not take EMPAGLIFLOZIN ZYDUS if you are pregnant or breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or health care provider for advice before taking EMPAGLIFLOZIN ZYDUS. It is not known if empagliflozin passes into human breast milk.
Driving and using machines
EMPAGLIFLOZIN ZYDUS has minor influence on the ability to drive a vehicle and use machines. Taking EMPAGLIFLOZIN ZYDUS 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 perform any tasks requiring your attention if you feel dizzy while taking EMPAGLIFLOZIN ZYDUS.
