Empagliflozin

Empagliflozin is used along with diet and exercise to lower blood sugar levels in adults and children who are at least 10 years old with type 2 diabetes.

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

Empagliflozin is also used in adults to reduce the risk of dying or needing to go to the hospital for heart failure when the heart cannot pump blood properly.

Empagliflozin is not for treating type 1 diabetes.

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

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.

Take empagliflozin once a day in the morning, 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.

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.

Tell your doctor if you have a planned surgery.

Store at room temperature away from moisture and heat.

Call your doctor immediately if you notice any serious side effects, like stomach pain, vomiting, tiredness, or trouble breathing.

Let your doctor know if you are sick with vomiting or diarrhea, or if you are eating or drinking less than you usually do.

Empagliflozin can lead to serious infections around the penis or vagina. Seek medical help right away if you experience burning, itching, odor, discharge, pain, tenderness, redness, or swelling in the genital or rectal area, fever, or if you feel unwell.

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 or have ever had:

• a bladder infection or problems urinating;
• a genital infection (in the penis or vagina);
• issues with your pancreas, including surgery;
• alcoholism, or if you currently drink large amounts of alcohol;
• if you are on a low salt diet, are eating less, or have changed your diet;
• if you are 65 or older; or
• liver or kidney disease.

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

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

Do not breastfeed.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty 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, or not feeling well. These symptoms may get worse quickly.

Empagliflozin may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• low blood sugar—headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery;
• dehydration—dizziness, confusion, feeling very thirsty, or 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, or pain in pelvis or back.

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.

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.

Avoid drinking alcohol.

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

Tell your doctor about all your other medicines, 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.