What is the most important information I should know about empagliflozin?
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.
What is empagliflozin?
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.
What should I discuss with my healthcare provider before taking empagliflozin?
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 this medicine 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.
Not approved for use by anyone younger than 18 years old.
How should I take empagliflozin?
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.
What happens if I miss a dose?
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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking empagliflozin?
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.
What are the possible side effects of empagliflozin?
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; 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:
- 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.
What other drugs will affect empagliflozin?
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.
Where can I get more information?
Your pharmacist can provide more information about empagliflozin.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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