Each film-coated tablet of Empa -M® contains: 

• Empagliflozin/Metformin        5 mg/850 mg
• Empagliflozin/Metformin        5 mg/1000 mg
• Empagliflozin/Metformin        12.5 mg/850 mg
• Empagliflozin/Metformin        12.5 mg/1000 mg

• Empa-M® is added to diet and exercise to treat type 2 diabetes in adult patients (aged 18 years and older) whose diabetes cannot be controlled by adding metformin alone or metformin with other medicines for diabetes. 
• Empa-M® can also be combined with other medicines for the treatment of diabetes.
• These may be medicines taken by mouth or given by injection such as insulin. 
• In addition, this medicine can be used as an alternative to taking both empagliflozin and metformin as single tablets.
• To avoid overdose, do not continue taking empagliflozin and metformin tablets separately, if you are taking this medicine. 
• It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or nurse

Do not use Empa -M®

• If you are allergic to empagliflozin, metformin or any of the other ingredients of this medicine 
• If you have uncontrolled diabetes, with, for example, severe hyperglycaemia (very high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis or ketoacidosis. Ketoacidosis is a condition in which substances called ‘ketone bodies’ accumulate in the blood and which can lead to diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell; 
• If you have had a diabetic pre-coma; 
• If you have severely reduced kidney function or problems with your liver. 
• If you have a severe infection such as an infection affecting your lung or bronchial system or your kidney. Severe infections may lead to kidney problems, which can put you at risk for lactic acidosis 
• If you have lost a lot of water from your body (dehydration), e.g. due to long-lasting or severe diarrhea, or if you have vomited several times in a row. Dehydration may lead to kidney problems, which can put you at risk for lactic acidosis 
• If you are treated for acute heart failure or have recently had a heart attack, have severe problems with your circulation (such as shock) or have breathing difficulties. This may lead to a lack in oxygen supply to tissue which can put you at risk for lactic acidosis 
• If you drink large amounts of alcohol, either every day or only from time to time

¤ If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X ray or scan, you must stop taking This medicine before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with this medicine. 

¤ Tell your doctor if you are taking, have recently taken or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of This medicine.

¤ It is especially important to mention the following: 

• medicines which increase urine production (diuretics), as This medicine may increase the risk of losing too much fluid. Your doctor may ask you to stop taking this medicine. 
• 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). 
• Medicines that may change the amount of metformin in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole, crizotinib, olaparib). 
• Bronchodilators (beta-2 agonists) which are used to treat asthma. 
• Corticosteroids (given by mouth, as an injection, or inhaled), which are used to treat inflammation in diseases like asthma and arthritis.
• Medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib)
• Certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
• Iodinated contrast agents (medicines used during an X-ray) excessive alcohol intake while taking this medicine since this may increase the risk of lactic acidosis.

• Do not take this medicine if you are pregnant. It is unknown if this medicine is harmful to the unborn child. 
• Metformin passes into human milk in small amounts. It is not known whether empagliflozin passes into human breast milk. Do not take this medicine if you are breastfeeding. 

Stop using the product and seek immediate medical attention if you:

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

Common side effects:

• genital yeast infection (thrush).
• thirst and 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.
• changes to the way things taste and thirst.
• blood tests may show an increase in blood fat (cholesterol) levels in your blood this include any possible side effects not listed in this leaflet. you can report side effect.

¤ The dose of this medicine varies depending on your condition and the doses of diabetes medicines you currently take.

¤ The recommended dose is one tablet twice a day. Your doctor will normally start this medicine treatment by prescribing the strength of tablet that supplies the same dose of metformin you are already taking (850 mg or 1,000 mg twice a day), and the lowest dose of empagliflozin (5 mg twice a day).  

¤ Taking this medicine:

• Swallow the tablet whole with water.
• Take the tablets with meals to lower your chance of an upset stomach.
• Take the tablet twice daily by mouth. 

¤ Your doctor may prescribe this medicine together with another diabetes medicine.

¤ Remember to take all medicines as directed by your doctor to achieve the best results for your health.

¤ This medicine is not recommended for use in children and adolescents under 18 years, because it has not been studied in these patients.

¤ Risk of lactic acidosis 
• Empa -M®  may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration, liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart diseases). 
«If any of the above apply to you, talk to your doctor for further instructions». 
• Symptoms of diabetic lactic acidosis include: 

• vomiting, stomach ache (abdominal pain), muscle cramps.
• a general feeling of not being well with severe tiredness.
• sweet smell to your breath or a sweet or metallic taste in your mouth.
• difficulty in breathing.
• reduced body temperature and heartbeat.

Lactic acidosis is a medical emergency and must be treated in a hospital. 

«Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment» : 

• If you experience symptoms of “diabetic ketoacidosis”. 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; 
• Might be at risk of dehydration. Your doctor may ask you to stop taking this medicine 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 this medicine due to limited therapeutic experience; 
• if you have a serious infection of the kidney or the urinary tract with fever. Your doctor may ask you to stop taking this medicine until you have recovered; 
• if you need to undergo an examination with iodination contrast agents (such as X-ray or scan). 
• Talk to your doctor immediately if you develop necrotizing fasciitis of the perineum or Fournier´s gangrene which destroys the tissue under the skin. Fournier’s gangrene has to be treated immediately. 

¤ Surgery:

• If you need to have major surgery you must stop taking this medicine during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with this medicine. 

¤ 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. 

• Empa -M® 5/ 850   Tablets (Blister of 5 Tablets, Pack of four blisters)
• Empa -M® 5/ 1000    Tablets (Blister of 5 Tablets, Pack of four blisters)
• Empa -M® 12.5/ 850   Tablets (Blister of 5 Tablets, Pack of four blisters)
• Empa -M® 12.5/ 1000 Tablets (Blister of 5 Tablets, Pack of four blisters)

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