All the information you need to start and stay on JARDIANCE, the type 2 diabetes pill that’s ON IT.

STARTING JARDIANCE

How to take JARDIANCE

JARDIANCE can easily fit into your routine. It is a once-daily pill taken in the morning, with or without food. It’s available in 10 mg and 25 mg empagliflozin tablets. Always take JARDIANCE exactly as your doctor prescribes.

Want to keep track of your progress?

Measure your blood sugar as your doctor recommends. At your next appointment, your doctor can update you on your A1C and help you identify trends in your blood glucose.

JARDIANCE & other medications

If you’re already taking medication for type 2 diabetes or heart disease, you can add JARDIANCE. This includes metformin, sulfonylurea, pioglitazone, and insulin as well as CV medications like statins, beta blockers, ACE inhibitors, and diuretics.

However, if you’re taking medications that can cause low blood sugar—like sulfonylurea or insulin—your dosage may need to be lowered since adding JARDIANCE can increase your risk of hypoglycemia (low blood sugar).

Remember, JARDIANCE does not replace your other prescribed medications and, as always, be sure to tell your doctor about all of the medicines you take.


STAYING ON IT WITH JARDIANCE

  • Seeing results

    Everyone’s results are different—and it can take up to 24 weeks before you see results with JARDIANCE, so it’s important to take it daily.

  • Eating right

    When it comes to maintaining healthy blood sugar levels, limiting unhealthy carbs and avoiding foods with a high-glycemic index can help. Your best move: setting a diet plan with your doctor that’s specific to your health needs and goals.

  • Staying motivated

    With type 2 diabetes, there’s a lot to manage. The American Heart Association recommends creating your own support team of doctors, specialists, family, and friends to help you stay on top of things.


JARDIANCE
 SIDE EFFECTS

Common side effects

Your body controls blood sugar in a number of ways. JARDIANCE helps eliminate blood sugars through urination. Common side effects are urinary tract infections and yeast infections. Tell your doctor if you experience these or other side effects.

PRO TIP: Good hygiene and drinking lots of water are your best defense. When you start JARDIANCE you may experience increased urination.

Serious side effects

Some of the more serious side effects include dehydration, vaginal yeast infections, yeast infection of the penis, ketoacidosis (increased ketones in your blood or urine), kidney problems, serious urinary tract infections, low blood sugar (hypoglycemia), necrotizing fasciitis (Fournier's gangrene), allergic reactions (hypersensitivity), and increased fat in the blood (cholesterol).

PRO TIP: Keep your doctor informed about any noticeable changes you experience while taking a new medication. They may be able to help mitigate side effects or identify signs of a bigger problem.

Am I at an increased risk for limb amputation or necrotizing fasciitis (Fournier’s gangrene)?

Based on an in-depth review of JARDIANCE safety information, no reliable evidence currently exists demonstrating that JARDIANCE increases the risk of amputation. The makers of JARDIANCE will continue to monitor safety information for the medication.

It's important to understand that having type 2 diabetes itself is understood to be the most significant risk factor of getting necrotizing fasciitis, also known as Fournier’s gangrene, when it occurs in the skin of the perineum. Necrotizing fasciitis is a rare but serious bacterial infection that causes damage to the tissue under the skin in the area between and around the anus and genitals (perineum). Necrotizing fasciitis can occur in both women and men, and may lead to hospitalization, multiple surgeries, and possibly death. While no cases of necrotizing fasciitis were seen in JARDIANCE clinical trials, rare cases have been reported in JARDIANCE and other medications in the same class since they have been marketed in the United States.

A small number of cases in patients taking JARDIANCE have been identified, which we continue to evaluate.

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)

While you may have seen media coverage about rare instances of this bacterial infection, it’s important to talk to your doctor about any questions or concerns you may have with SGLT2 inhibitors or JARDIANCE. If you have any questions, talk to your doctor.

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WHAT IS JARDIANCE?

JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes, and also 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 or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

IMPORTANT SAFETY INFORMATION

  • Do not take JARDIANCE if you are allergic to empagliflozin or any of the ingredients in JARDIANCE.
  • Do not take JARDIANCE if you have severe kidney problems or are on dialysis.

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. You may be at a higher risk of dehydration if you: have low blood pressure, take medicines to lower your blood pressure, including water pills (diuretics), are on a low salt diet, have kidney problems, are 65 years of age or older.
  • Vaginal yeast infection. Women who take JARDIANCE may get vaginal yeast infections. Talk to your doctor if you experience vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), and/or vaginal itching.
  • Yeast infection of the penis. Men who take JARDIANCE may get a yeast infection of the skin around the penis, especially uncircumcised males and those with chronic infections. Talk to your doctor if you experience redness, itching or swelling of the penis, rash of the penis, foul smelling discharge from the penis, and/or pain in the skin around the penis.
  • Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis is a serious condition and may need to be treated in the hospital. Ketoacidosis may lead to death. Ketoacidosis occurs in people with type 1 diabetes and can also occur in people with type 2 diabetes taking JARDIANCE, even if 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, and if possible, check for ketones in your urine: nausea, vomiting, stomach-area (abdominal) pain, tiredness, or trouble breathing.
  • Kidney problems. Sudden kidney injury has happened in people taking JARDIANCE. Talk to your doctor right away if you reduce the amount you eat or drink, or if you lose liquids; for example, from vomiting, diarrhea, or being in the sun too long.
  • Serious urinary tract infections. Serious urinary tract infections can occur in people taking JARDIANCE and may lead to hospitalization. Tell your doctor if you have symptoms of a urinary tract infection, such as a burning feeling when passing urine, a need to urinate often or right away, pain in the lower part of your stomach or 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 sulfonylurea or insulin, your risk of low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered. Symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking or feeling jittery.
  • Necrotizing fasciitis. A rare but serious bacterial infection that causes damage to the tissue under the skin in the area between and around your anus and genitals (perineum). This bacterial infection has happened in women and men who take JARDIANCE, and may lead to hospitalization, multiple surgeries, and death. Seek medical attention immediately if you have fever or 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, and redness of skin (erythema).
  • Allergic (hypersensitivity) reactions. Symptoms of serious allergic reactions to JARDIANCE 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 contact your doctor or go to the nearest emergency room right away.
  • Increased fats in your blood (cholesterol).

The most common side effects of JARDIANCE include urinary tract infections and yeast infections in females. These are not all the possible side effects of JARDIANCE. For more information, ask your doctor or pharmacist.

Before you take JARDIANCE, tell your doctor if you have kidney problems. Your doctor may do blood tests to check your kidneys before and during your treatment with JARDIANCE. Also tell your doctor if you 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. Tell your doctor if you are breastfeeding or are planning to breastfeed. JARDIANCE may pass into your breast milk and may harm your baby. 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. Especially tell your doctor if you take water pills (diuretics) or medicines that can lower your blood sugar, such as insulin.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

For more information, please see Prescribing Information and Medication Guide.

CL-JAR-100026 10.30.18

WHAT IS JARDIANCE?

JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes, and also 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 or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

IMPORTANT SAFETY INFORMATION

  • Do not take JARDIANCE if you are allergic to empagliflozin or any of the ingredients in JARDIANCE.
  • Do not take JARDIANCE if you have severe kidney problems or are on dialysis.

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. You may be at a higher risk of dehydration if you: have low blood pressure, take medicines to lower your blood pressure, including water pills (diuretics), are on a low salt diet, have kidney problems, are 65 years of age or older.
  • Vaginal yeast infection. Women who take JARDIANCE may get vaginal yeast infections. Talk to your doctor if you experience vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), and/or vaginal itching.
  • Yeast infection of the penis. Men who take JARDIANCE may get a yeast infection of the skin around the penis, especially uncircumcised males and those with chronic infections. Talk to your doctor if you experience redness, itching or swelling of the penis, rash of the penis, foul smelling discharge from the penis, and/or pain in the skin around the penis.
  • Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis is a serious condition and may need to be treated in the hospital. Ketoacidosis may lead to death. Ketoacidosis occurs in people with type 1 diabetes and can also occur in people with type 2 diabetes taking JARDIANCE, even if 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, and if possible, check for ketones in your urine: nausea, vomiting, stomach-area (abdominal) pain, tiredness, or trouble breathing.
  • Kidney problems. Sudden kidney injury has happened in people taking JARDIANCE. Talk to your doctor right away if you reduce the amount you eat or drink, or if you lose liquids; for example, from vomiting, diarrhea, or being in the sun too long.
  • Serious urinary tract infections. Serious urinary tract infections can occur in people taking JARDIANCE and may lead to hospitalization. Tell your doctor if you have symptoms of a urinary tract infection, such as a burning feeling when passing urine, a need to urinate often or right away, pain in the lower part of your stomach or 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 sulfonylurea or insulin, your risk of low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered. Symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking or feeling jittery.
  • Necrotizing fasciitis. A rare but serious bacterial infection that causes damage to the tissue under the skin in the area between and around your anus and genitals (perineum). This bacterial infection has happened in women and men who take JARDIANCE, and may lead to hospitalization, multiple surgeries, and death. Seek medical attention immediately if you have fever or 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, and redness of skin (erythema).
  • Allergic (hypersensitivity) reactions. Symptoms of serious allergic reactions to JARDIANCE 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 contact your doctor or go to the nearest emergency room right away.
  • Increased fats in your blood (cholesterol).

The most common side effects of JARDIANCE include urinary tract infections and yeast infections in females. These are not all the possible side effects of JARDIANCE. For more information, ask your doctor or pharmacist.

Before you take JARDIANCE, tell your doctor if you have kidney problems. Your doctor may do blood tests to check your kidneys before and during your treatment with JARDIANCE. Also tell your doctor if you 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. Tell your doctor if you are breastfeeding or are planning to breastfeed. JARDIANCE may pass into your breast milk and may harm your baby. 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. Especially tell your doctor if you take water pills (diuretics) or medicines that can lower your blood sugar, such as insulin.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

For more information, please see Prescribing Information and Medication Guide.

CL-JAR-100026 10.30.18

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