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

Empagliflozin 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.

Empagliflozin is also used to lower the risk of dying or needing to be in a hospital for heart failure when your heart cannot pump blood properly.

Empagliflozin is not for treating type 1 diabetes.

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

Stop taking this medicine and call your doctor at once if you have signs of a serious side effect, such as stomach pain, vomiting, tiredness, or trouble breathing.

Tell your doctor if you are sick with vomiting or diarrhea, or if you eat or drink less than usual.

Empagliflozin can cause serious infections around the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or if you don't feel well.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take empagliflozin with or without food.

Your blood sugar will need to be checked often, and you may also need to test the level of ketones in your urine. Empagliflozin can cause life-threatening ketoacidosis (too much acid in the blood). Even if your blood sugar is normal, contact your doctor if a urine test shows that you have high ketones in the urine.

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injection in case of severe hypoglycemia.

You may get dehydrated during prolonged illness. Call your doctor if you are sick with vomiting or diarrhea, or if you eat or drink less than usual.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using empagliflozin.

Your treatment may also include diet, exercise, weight control, and special medical care.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Diabetes Type 2:

10 mg orally once a day in the morning
-For additional glycemic control in patients tolerating this drug: May increase to 25 mg orally once a day

Uses:
-To reduce the risk of cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease
-As an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes mellitus

Usual Adult Dose for Cardiovascular Risk Reduction:

10 mg orally once a day in the morning
-For additional glycemic control in patients tolerating this drug: May increase to 25 mg orally once a day

Uses:
-To reduce the risk of cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease
-As an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes mellitus

Usual Adult Dose for Heart Failure:

10 mg orally once a day in the morning

Use: To reduce the risk of cardiovascular death and hospitalization for heart failure in patients with heart failure

You should not use empagliflozin if you are allergic to it, or if you have:

• severe kidney disease (or if you are on dialysis).

Tell your doctor if you have ever had:

• liver or kidney disease;

• a bladder infection or urination problems;

• a genital infection (penis or vagina);

• problems with your pancreas, including surgery;

• alcoholism, or if you currently drink large amounts of alcohol;

• if you are on a low salt diet; or

• if you are 65 or older.

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

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

Do not breastfeed.

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

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthful diet and exercise regularly. Follow your doctor's instructions about drinking enough fluids throughout the day while you are on this medication.

Avoid drinking alcohol.

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

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 empagliflozin 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; 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 of empagliflozin may include:

• a bladder infection; or

• yeast infection in women (vaginal itching or discharge).

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.

Other drugs may increase or decrease the effects of empagliflozin on lowering your blood sugar. Tell your doctor about all your current medicines and any you start or stop using, especially:

• insulin, or other oral diabetes medicine; or

• a diuretic or "water pill."

This list is not complete. Other drugs may affect empagliflozin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your blood sugar levels should be checked regularly to determine your response to empagliflozin. Your doctor will order other lab tests, including glycosylated hemoglobin (HbA1c), to check your response to empagliflozin. Your doctor will also tell you how to check your response to this medication by measuring your blood sugar levels at home. Follow these instructions carefully.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking empagliflozin. Because of the way this medication works, your urine may test positive for glucose.

You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.