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JARDIANCE- empagliflozin tablet, film coated


  1. Patient Information
  2. What Is Jardiance?
  3. Are Allergic To Empagliflozin Or Any Of The Ingredients In Jardiance. Before You Take Jardiance, Tell Your Doctor If You:
  4. Jardiance May Affect The Way Other Medicines Work, And Other Medicines May Affect How Jardiance Works.especially Tell Your Doctor If You Take:
  5. How Should I Take Jardiance?
  6. Jardiance May Cause Serious Side Effects, Including:
  7. Active Ingredient:
  8. Inactive Ingredients:

Patient Information ⮝

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Instructions
Instruct patients to read the Medication Guide before starting JARDIANCE therapy and to reread it each time the prescription is renewed. Instruct patients to inform their doctor or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens.

Inform patients of the potential risks and benefits of JARDIANCE and of alternative modes of therapy. Also inform patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. Advise patients to
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.
    • 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.

Are Allergic To Empagliflozin Or Any Of The Ingredients In 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.
  • 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: ⮝

  • Ketoacidosis (increased ketones in your blood or urine).Ketoacidosis has happened in people who havetype 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.
    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 towww.jardiance.com, scan the code below, or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or (TTY) 1-800-459-9906.qr-code

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

Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the Jardianceand EMPA-REG OUTCOMEtrademarks under license.
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

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