Empagliflozin and metformin is a combination medicine used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Empagliflozin and metformin is also used to lower the risk of death from heart attack, stroke, or heart failure in adults with type 2 diabetes who also have heart disease.

This medicine is not for treating type 1 diabetes.

Empagliflozin and metformin may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to empagliflozin or metformin, or if you have:

• severe kidney disease (or if you are on dialysis); or
• metabolic acidosis or diabetic ketoacidosis (call your doctor for treatment).

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking this medicine. Be sure your caregivers know ahead of time that you are using empagliflozin and metformin.

Tell your doctor if you have ever had:

• liver or kidney disease;
• a bladder infection or urination problems;
• congestive heart failure, a heart attack or stroke;
• a genital infection (penis or vagina);
• problems with your pancreas, including surgery;
• if you are on a low salt diet; or
• if you are 65 or older.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Ask your doctor about your risk.

Follow your doctor's instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy.

You should not use empagliflozin and metformin during the second or third trimester of pregnancy.

Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

Do not breastfeed.

Not approved for use by anyone younger than 18 years old.

Use Synjardy XR (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; trouble swallowing, difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical attention right away if you have signs of a serious genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well. These symptoms may get worse quickly.

Stop taking this medicine and call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• dehydration--dizziness, confusion, feeling very thirsty, less urination;
• ketoacidosis (too much acid in the blood)--nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing;
• lactic acidosis--unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired; or
• signs of a bladder infection--pain or burning when you urinate, blood in your urine, pain in pelvis or back.

Some side effects may be more likely to occur in older adults.

Common side effects may include:

• low blood sugar;
• indigestion, stomach pain, gas, nausea, vomiting, diarrhea;
• a bladder infection;
• yeast infection in women (vaginal itching or discharge);
• headache, weakness; or
• runny or stuffy nose, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid drinking alcohol. It may increase your risk of lactic acidosis.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.