• Empagliflozin is used to treat type 2 diabetes in adult patients (aged 18 years and older) that cannot be controlled by diet and exercise alone.
• Empagliflozin can be used without other medicines in patients who cannot take metformin (another diabetes medicine).
• Empagliflozin can also be used with other medicines for the treatment of diabetes. These may be medicines taken by mouth or given by injection such as insulin. It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or nurse.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much to take

• The starting dose of Empagliflozin is one 10 mg tablet once a day. Your doctor will decide whether to increase your dose to 25 mg once a day.
• Your doctor may limit your dose to 10 mg once a day if you have a kidney problem.
• Your doctor will prescribe the strength that is right for you. Do not change your dose unless your doctor has told you to.

Taking this medicine

Swallow the tablet whole with water with or without food

You can take the tablet at any time of the day. However, try to take it at the same time each day. This will help you to remember to take it. Your doctor may prescribe Empagliflozin together with another diabetes medicine. Remember to take all medicines as directed by your doctor to achieve the best results for your health. Appropriate diet and exercise help your body use its blood sugar better. It is important to stay on the diet and exercise program recommended by your doctor while taking Empagliflozin.

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 Empagliflozin.
• 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 (hypoglycemia).

Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact a doctor or the nearest hospital straight away if you have any of the following side effects:

Severe allergic reaction, seen with unknown frequency (frequency cannot be estimated from the available data) Possible signs of severe allergic reaction may include:

• swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing

Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis

• increased levels of “ketone bodies” in your urine or blood
• 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.

This may occur regardless of blood glucose level. Your doctor may decide to temporarily or permanently stop your treatment with Empagliflozin.

Contact your doctor as soon as possible if you notice the following side effects:

Low blood sugar (hypoglycemia), seen very commonly (may affect more than 1 in 10 people) If you take Empagliflozin with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The signs of low blood sugar may include:

• shaking, sweating, feeling very anxious or confused, fast heart beat, excessive hunger, headache

Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs above. If you have symptoms of low blood sugar, eat glucose tablets, a high sugar snack or drink fruit juice. Measure your blood sugar if possible and rest.

Urinary tract infection, seen commonly (may affect up to 1 in 10 people) The signs of urinary tract infection are:

• burning sensation when passing urine, urine that appears cloudy, pain in the pelvis, or mid-back pain (when kidneys are infected)

An urge to pass urine or more frequent urination may be due to the way Empagliflozin works, but they can also be signs of urinary tract infection. If you note an increase in such symptoms, you should also contact your doctor.

Dehydration, seen uncommonly (may affect up to 1 in 100 people) The signs of dehydration are not specific, but may include:

• unusual thirst, lightheadedness or dizziness upon standing
• fainting or loss of consciousness

Other side effects while taking Empagliflozin:

Common

• genital yeast infection (thrush)
• passing more urine than usual or needing to pass urine more often
• itching
• rash or red skin – this may be itchy and include raised bumps, oozing fluid or blisters
• thirst
• blood tests may show an increase in blood fat (cholesterol) levels in your blood

Uncommon

• hives
• straining or pain when emptying the bladder
• blood tests may show a decrease in kidney function (creatinine or urea)
• blood tests may show increases in the amount of red blood cells in your blood (haematocrit)

Not known

• necrotising fasciitis of the perineum or Fournier’s gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus

Do not take Empagliflozin

• if you are allergic to empagliflozin

Warnings and precautions

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.
• 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 serious kidney or liver problems – your doctor may ask you to take a different medicine.
• might be at risk of dehydration, for example:
  • if you are being sick, have diarrhoea or fever, or if you are not able to eat or drink
  • if you are taking medicines that increase urine production [diuretics] or lower blood pressure
  • if you are over 75 years old.

Your doctor may ask you to stop taking Empagliflozin 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 Empagliflozin .
• if you have a serious infection of the kidney or the urinary tract with fever. Your doctor may ask you to stop taking Empagliflozin 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 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: Empagliflozin is not recommended for children and adolescents under 18 years, because it has not been studied in these patients.

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 Empagliflozin if you are pregnant. It is unknown if Empagliflozin is harmful to the unborn child. Do not use Empagliflozin if you are breast-feeding. It is not known if Empagliflozin passes into human breast milk.

Driving and using machines

Empagliflozin 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 Empagliflozin.