• Do not use if you are allergic to empagliflozin, linagliptin, any other SGLT2 inhibitor , any other DPP‑4 inhibitor, or any of the other ingredients of this medicine .

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. In particular, you should tell your doctor if you are using the following medicines:
• other anti-diabetic medicines, such as insulin or a sulphonylurea. Your doctor may want to lower the  of these other medicines, to prevent your blood sugar levels from getting too low.
• medicines used to remove water from your body (diuretics). Your doctor may ask you to stop taking Empalipt®.
• medicines that might have an effect on the break down of empagliflozin or linagliptin in your body such as rifampicin (an antibiotic used to treat tuberculosis) or certain medicines used to treat seizures (such as carbamazepine, phenobarbital or phenytoin). The effect of Empalipt® may be reduced.
• lithium because Empalipt® can lower the amount of lithium in your blood.

 If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. It is not known whether Empalipt® is harmful to the unborn child. As a precautionary measure it is preferable to avoid the use of this medicine during pregnancy.
It is not known whether the active substances of Empalipt® pass into human breast milk.
 Do not use this medicine if you are breast-feeding.

 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:
Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1000 people).
These are the signs of diabetic ketoacidosis see also section (1) Warnings and precautions. This may occur regardless of blood glucose level. Your doctor may decide to temporarily
or permanently stop your treatment with this medicine.
Contact your doctor immediately if you notice any of the following side effects:
Allergic reactions, seen uncommonly (may affect up to 1 in 100 people)
This medicine may cause allergic reactions, which may be serious, including hives (urticaria) and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing (angioedema).
Inflammation of the pancreas (pancreatitis), seen uncommonly
This medicine may cause pancreatitis, which usually shows as persistent, severe abdominal (stomach) pain that might reach through to your back, often accompanied by feeling sick or being sick. Your doctor will need to change your treatment.
Low blood sugar (hypoglycaemia), seen commonly (may affect up to 1 in 10 people)
If you take Empalipt® with another medicine that can cause low blood sugar, such as a sulphonylurea or insulin, you are at risk of getting too low blood sugar (hypoglycaemia). The signs of too 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 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 this medicine works, but as they can also be signs of urinary tract infection, if you note an increase in such symptoms, you should also contact your doctor.
Loss of body fluid (dehydration), seen uncommonly
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 Empalipt®:
Seen commonly:genital yeast infection like thrush, inflamed nose or throat (nasopharyngitis),
cough, passing more urine than usual or needing to pass urine more often, itching, skin rash ,increased blood enzyme amylase, increased pancreas enzyme lipase, thirst, constipation 
Seen uncommonly:straining or pain when emptying the bladder, laboratory blood tests may show changes in blood fat levels, an increase in the amount of red blood cells (increase in haematocrit), and changes related to kidney function (decrease in filtration rate and increase in blood creatinine)
Seen rarely: sore in the mouth, 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.

Talk to your doctor, before taking this medicine, and during treatment:
• If you have “type 1 diabetes”.  You should not take Empalipt® if you have type 1 diabetes.
• 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 and stop taking this medicine until further advice from your doctor. 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 or sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness.
•If you are taking other anti-diabetic medicines known as sulphonylurea  and/or using insulin.
•If you have or have had a disease of the pancreas.
•If you have serious kidney problems. Your doctor may limit your daily dose.
•If you have serious liver problems. Your doctor may ask you to take a different medicine.
•If you 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 Empalipt® until you recover to prevent loss of too much body fluid. 
•If you have an increase in the proportion of red blood cells in your blood (haematocrit), seen in laboratory blood tests
Contact your doctor if you experience any of the following during treatment with Empalipt®:
•If you develop symptoms of acute pancreatitis, like persistent, severe stomach ache (abdominal pain). Your doctor may need to change your treatment.
•If you have a serious infection of the kidney or the urinary tract with fever. Your doctor may ask you to stop taking Empalipt® until you have recovered.
• if you encounter blistering of the skin it may be a sign for a condition called bullous pemphigoid. Your doctor may ask you to stop Empalipt®. 
Kidney function 
 During treatment with this medicine, 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. 

• Empalipt®         10/ 5           Tablets (Blister of 10 Tablets, Pack of three blisters).
• Empalipt®         25/ 5           Tablets (Blister of 10 Tablets, Pack of three blisters).

• Store in a dry place at a temperature  not exceeding 25 ºC. 
• Keep out of the reach of children.