Each  tablet of EMPA®  10 contains:   

• Empagliflozin         10 mg

Each  tablet of EMPA®  25 contains:   

• Empagliflozin         25 mg

• EMPA® is used to treat type 2 diabetes in adult patients (aged 18 years and older) that cannot be controlled by diet and exercise alone.
• EMPA® can be used without other medicines in patients who cannot take metformin (another diabetes medicine).
• EMPA® 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.

Do not use EMPA®:

• if you are allergic to empagliflozin or any of the other ingredients of this medicine.
• if you are pregnant, or if you are breastfeeding.
• if you are on dialysis.

• Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
• if you are taking medicines that increase urine production (diuretics).
• 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 pregnant or breastfeeding, 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 EMPA® if you are pregnant. It is unknown if EMPA® is harmful to the unborn child.
• Do not use EMPA® if you are breastfeeding. It is not known if Empagliflozin passes into human breast milk.

¤ Stop using the product and seek immediate medical attention if you develop

• urticaria, rash, tightness of the chest, wheezing, hypotension.

Common side effects:

• Low blood sugar (hypoglycaemia).
• Urinary tract infection.
• 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 you blood 

Uncommon side effects

• 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).

¤ Always take EMPA® 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 EMPA® 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 

• You can take the tablet with or without food

• You can take the tablet at any time of the day. However, try to take it at thesame time each day. This will help you to remember to take it.

• Your doctor may prescribe EMPA® 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 EMPA®.

• If you take more EMPA® than you should, talk to a doctor immediately or goto a hospital immediately. Take the medicine pack with you.

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.

• if you are 85 years old or older as you should not start taking EMPA®.
•  if you have a serious infection of the kidney or the urinary tract with fever.  Your doctor may ask you to stop taking EMPA® 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.

Children and adolescents:

• EMPA® is not recommended for children and adolescents under 18 years, because it has not been studied in these patients.

• EMPA® 25: pack of 2 blisters, blister of 10 tablets.
• EMPA® 10: pack of 2 blisters, blister of 10 tablets.

• Store in a dry place at temperature not exceeding 25ºC.