What is Jardiance?
- Jardiance is a prescription medicine used:
- along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
- to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.
- Jardiance is not for people with type 1 diabetes.
- Jardiance is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).
- It is not known if Jardiance is safe and effective in children under 18 years of age.
What is the most important information I should know about Jardiance?
Jardiance can cause serious side effects, including:
- Dehydration. Jardiance can cause some people to have dehydration (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up (orthostatic hypotension).
You may be at higher risk of dehydration if you:
- have low blood pressure
- take medicines to lower your blood pressure, including diuretics (water pills)
- are on low sodium (salt) diet
- have kidney problems
- are 65 years of age or older
- Vaginal yeast infection. Women who take Jardiance may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:
- vaginal odor
- white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
- vaginal itching
- Yeast infection of the penis (balanitis or balanoposthitis). Men who take Jardiance may get a yeast infection of the skin around the penis. Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include:
- redness, itching, or swelling of the penis
- rash of the penis
- foul smelling discharge from the penis
- pain in the skin around penis
Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis. Your doctor may suggest you use an over-the-counter antifungal medicine. Talk to your doctor right away if you use an over-the-counter antifungal medication and your symptoms do not go away.
Who should not take Jardiance?
Do not take Jardiance if you:
- are allergic to empagliflozin or any of the ingredients in Jardiance. See the end of this Medication Guide for a list of ingredients in Jardiance.
- have severe kidney problems or are on dialysis
What should I tell my healthcare provider before taking Jardiance?
Before you take Jardiance, tell your doctor if you:
- have kidney problems
- have liver problems
- have a history of urinary tract infections or problems with urination
- are going to have surgery. Your doctor may stop your Jardiance before you have surgery. Talk to your doctor if you are having surgery about when to stop taking Jardiance and when to start it again.
- are eating less, or there is a change in your diet
- have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas
- drink alcohol very often, or drink a lot of alcohol in the short term ("binge" drinking)
- have any other medical conditions
- are pregnant or plan to become pregnant. Jardiance may harm your unborn baby. If you become pregnant while taking Jardiance, tell your doctor as soon as possible. Talk with your doctor about the best way to control your blood sugar while you are pregnant.
- are breastfeeding or plan to breastfeed. Jardiance may pass into your breast milk and may harm your baby. Talk with your doctor about the best way to feed your baby if you are taking Jardiance. Do not breastfeed while taking Jardiance.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Jardiance may affect the way other medicines work, and other medicines may affect how Jardiance works.
Especially tell your doctor if you take:
- diuretics (water pills)
- insulin or other medicines that can lower your blood sugar
Ask your doctor or pharmacist for a list of these medicines if you are not sure if your medicine is listed above.
How should I take Jardiance?
- Take Jardiance exactly as your doctor tells you to take it.
- Take Jardiance by mouth 1 time in the morning each day, with or without food.
- Your doctor may change your dose if needed.
- If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take two doses of Jardiance at the same time. Talk with your doctor if you have questions about a missed dose.
- Your doctor may tell you to take Jardiance along with other diabetes medicines. Low blood sugar can happen more often when Jardiance is taken with certain other diabetes medicines. See “What are the possible side effects of Jardiance?”
- If you take too much Jardiance, call your doctor or go to the nearest hospital emergency room right away.
- When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine that you need may change. Tell your doctor right away if you have any of these conditions and follow your doctor’s instructions.
- Check your blood sugar as your doctor tells you to.
- Stay on your prescribed diet and exercise program while taking Jardiance.
- Talk to your doctor about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and complications of diabetes.
- Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin HbA1c.
- When taking Jardiance, you may have sugar in your urine, which will show up on a urine test.
Jardiance may cause serious side effects, including:
- See “What is the most important information I should know about Jardiance?”.
- Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 diabetes or type 2 diabetes, during treatment with Jardiance. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with Jardiance. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with Jardiance even if your blood sugar is less than 250 mg/dL. Stop taking Jardiance and call your doctor right away if you get any of the following symptoms:
- stomach-area (abdominal) pain
- trouble breathing
If you get any of these symptoms during treatment with Jardiance, if possible, check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.
- Kidney problems. Sudden kidney injury has happened to people taking Jardiance. Talk to your doctor right away if you:
- reduce the amount of food or liquid you drink for example, if you are sick or cannot eat or
- start to lose liquids from your body for example, from vomiting, diarrhea or being in the sun too long
- Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking Jardiance. Tell your doctor if you have any signs or symptoms of a urinary tract infection such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting.
- Low blood sugar (hypoglycemia). If you take Jardiance with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take Jardiance. Signs and symptoms of low blood sugar may include:
- fast heartbeat
- shaking or feeling jittery
- A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in women and men who take Jardiance. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries, and may lead to death. Seek medical attention immediately if you have a fever or you are feeling very weak, tired or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals:
- pain or tenderness
- redness of skin (erythema)
- Allergic (hypersensitivity) reactions. Serious allergic reactions have happened in people who are taking Jardiance. Symptoms may include:
- swelling of your face, lips, throat and other areas of your skin
- difficulty with swallowing or breathing
- raised, red areas on your skin (hives)
If you have any of these symptoms, stop taking Jardiance and call your doctor right away or go to the nearest hospital emergency room.
- Increased fats in your blood (cholesterol)
These are not all the possible side effects of Jardiance. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of Jardiance.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Jardiance for a condition for which it is not prescribed. Do not give Jardiance to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information about Jardiance. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Jardiance that is written for health professionals.
For more information about Jardiance including current prescribing information and Medication Guide, go to www.Jardiance.com or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or (TTY) 1-800-459-9906
How should I store Jardiance?
Store Jardiance at room temperature 68°F to 77°F (20°C to 25°C).
Keep out of sight and reach of children.
What are the ingredients in Jardiance?
Active Ingredient: empagliflozin
Inactive Ingredients: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide and magnesium stearate.
In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, talc, polyethylene glycol, and yellow ferric oxide.