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Jardiance (empagliflozin) is an oral diabetes medicine that helps control blood sugar levels. Empagliflozin works by helping the kidneys get rid of glucose from your bloodstream.

Jardiance is used together with diet and exercise to treat type 2 diabetes.

Jardiance is not for treating type 1 diabetes.

Important information

You should not use Jardiance if you have severe kidney disease, if you are on dialysis, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin). Jardiance is not for treating type 1 diabetes.

Before taking this medicine

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

  • kidney disease (or if you are on dialysis); or

  • if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure Jardiance is safe for you, tell your doctor if you have:

  • kidney disease;

  • low blood pressure;

  • high cholesterol levels;

  • urination problems;

  • a history of bladder infections;

  • if you are on a low salt diet; or

  • if you are 65 or older.

It is not known whether Jardiance will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether empagliflozin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Jardiance.

How should I take Jardiance?

Jardiance is usually taken once per day in the morning. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Jardiance with or without food, but take it the same way each time.

Your blood sugar will need to be checked often, and you may need other medical tests at your doctor"s office.

You may have very low blood pressure while taking this medication. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.

If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your Jardiance dose or dosing schedule without your doctor"s advice.

This medicine can cause positive results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Jardiance.

Jardiance is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor"s instructions very closely.

Store at room temperature away from moisture and heat.

Jardiance dosing information

Usual Adult Dose for Diabetes Type 2:

Initial dose: 10 mg orally once in the morning
Maximum dose: 25 mg orally once in the morning

Comments:
-Limitation of use: Should not be used in Type 1 diabetes mellitus or diabetic ketoacidosis
-Take with or without food

Use: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus

What other drugs will affect Jardiance?

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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 Jardiance?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Jardiance side effects

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

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;

  • frequent urge to urinate;

  • swelling, rapid weight gain, little or no urinating;

  • dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

  • ketoacidosis (too much acid in the blood) - nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing:

  • signs of a bladder infection--pain or burning when you urinate, urine that looks cloudy, pain in pelvis or back; or

  • signs of a genital infection (penis or vagina)--pain, burning, itching, rash, redness, odor, or discharge.

Older adults may be more likely to have side effects from this medicine.

Common Jardiance side effects may include:

  • bladder infection; or

  • genital infection.

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.

See also: Side effects (in more detail)

What other drugs will affect Jardiance?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Jardiance, especially:

  • blood pressure medicine;

  • a diuretic or "water pill"; or

  • insulin or other oral diabetes medications.

This list is not complete. Other drugs may interact with empagliflozin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.


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