MEDICATION GUIDE JARDIANCE® (jar DEE ans)


(empagliflozin) Tablets


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.


What is JARDIANCE?


• JARDIANCE is a prescription medicine used: { along with diet and exercise to lower blood sugar in adults with type 2 diabetes.


• JARDIANCE is not for people with type 1 diabetes. • JARDIANCE is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).


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


{ to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.


• It is not known if JARDIANCE is safe and effective in children under 18 years of age.


What should I tell my doctor before using 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 • are eating less due to illness, surgery, or 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.


• Talk to your doctor about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and complications of diabetes.


• Check your blood sugar as your doctor tells you to. • Stay on your prescribed diet and exercise program while taking JARDIANCE.


• 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.


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