What are the possible side effects of JARDIANCE? 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 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:


{ nausea { vomiting { stomach-area (abdominal) pain


{ tiredness { 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), or 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:


{ headache { drowsiness { weakness { irritability { hunger


{ fast heartbeat { confusion { shaking or feeling jittery { dizziness { sweating


• 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 { swelling


{ 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.


How should I store JARDIANCE? Store JARDIANCE at room temperature 68°F to 77°F (20°C to 25°C).


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, scan the code below, or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or (TTY) 1-800-459-9906.


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.


Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc.; Ridgefield, CT 06877 USA Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc.; Ridgefield, CT 06877 USA and Eli Lilly and Company, Indianapolis, IN 46285 USA Licensed from: Boehringer Ingelheim International GmbH, Ingelheim, Germany


The other trademarks referenced are owned by third parties not affiliated with Boehringer Ingelheim Pharmaceuticals, Inc.


Copyright © 2018 Boehringer Ingelheim International GmbH ALL RIGHTS RESERVED


IT5728SJ232018


This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: October 2018 PC-US-107303


Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the Jardiance®


and EMPA-REG OUTCOME® trademarks under license.


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