An FDA-Approved Type 2 Diabetes Treatment

SYNJARDY® (empagliflozin/metformin HCI) tablets 5mg/500mg, 5mg/1000mg, 12.5mg/500mg, 12.5mg/100mg

Learn more below, and ask your doctor if SYNJARDY is right for you.

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WHAT IS SYNJARDY?

SYNJARDY is a prescription medicine that contains 2 diabetes medicines, empagliflozin (JARDIANCE) and metformin. SYNJARDY can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

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

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about SYNJARDY?

SYNJARDY can cause serious side effects, including Lactic Acidosis (a build-up of lactic acid in the blood). Metformin, one of the medicines in SYNJARDY, can cause lactic acidosis, a rare, but serious condition that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.

Call your doctor right away if you get any of the following symptoms of lactic acidosis: cold in your hands or feet; feel dizzy or lightheaded; slow or irregular heartbeat; feel very weak or tired; have unusual muscle pain; have trouble breathing; feel sleepy or drowsy; have stomach pains, nausea, or vomiting.

You have a higher chance of getting lactic acidosis with SYNJARDY if you: have moderate to severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye; have liver problems; drink alcohol very often, or drink a lot of alcohol in the short-term (“binge” drinking); get dehydrated (lose a large amount of body fluids); have surgery; have a heart attack, severe infection, or stroke.

Who should not take SYNJARDY?

Do not take SYNJARDY if you:

  • have moderate to severe kidney problems or are on dialysis
  • have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine)
  • are allergic to empagliflozin (JARDIANCE), metformin, or any of the ingredients in SYNJARDY. Symptoms of serious allergic reactions to SYNJARDY may include skin rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing. If you have any of these symptoms, stop taking SYNJARDY and contact your doctor or go to the nearest emergency room right away

What should I tell my doctor before using SYNJARDY?

Tell your doctor about all of your medical conditions, including if you:

  • have moderate to severe kidney problems. Your doctor may do blood tests to check your kidneys before and during treatment with SYNJARDY
  • have liver problems
  • have a history of urinary tract infection or problems with urination
  • have heart problems, including congestive heart failure
  • 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)
  • are going to get an injection of dye or contrast agents for an x-ray procedure. SYNJARDY may need to be stopped for a short time. Talk to your doctor about when you should stop SYNJARDY and when you should start SYNJARDY again
  • have type 1 diabetes. SYNJARDY should not be used in people with type 1 diabetes
  • are pregnant or planning to become pregnant. SNYJARDY may harm your unborn baby. Tell your doctor right away if you become pregnant while taking SYNJARDY
  • are a premenopausal woman (before the “change of life”), who does not have periods regularly or at all. Talk to your doctor about birth control choices while taking SYNJARDY as it may increase your chances of becoming pregnant
  • are breastfeeding or plan to breastfeed. SYNJARDY may pass into your breast milk and may harm your baby. Do not breastfeed while taking SYNJARDY.

Tell your doctor about all the medicines you take including prescription or over-the-counter medicines, vitamins, or herbal supplements.

What are the possible side effects of SYNJARDY?

SYNJARDY may cause serious side effects including:

Dehydration. SYNJARDY 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 higher risk of dehydration if you have low blood pressure, kidney problems, are 65 years of age or older, on a low salt diet, or take medicines to lower your blood pressure, including water pills (diuretics).

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 SYNJARDY, even if blood sugar is less than 250 mg/dL. Stop taking SYNJARDY and call your doctor right away if you get any of the following symptoms, and, if possible, check for ketones in your urine:

  • nausea
  • tiredness
  • vomiting
  • trouble breathing
  • stomach-area (abdominal) pain
  • nausea
  • vomiting
  • stomach-area (abdominal) pain
  • tiredness
  • trouble breathing

Serious urinary tract infections. Serious urinary tract infections can occur in people taking SYNJARDY 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.

Kidney problems. SYNJARDY can cause kidney problems, especially in people 75 years of age or older and people who already have kidney problems.

Low blood sugar (hypoglycemia). If you take SYNJARDY 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. Symptoms of low blood sugar may include headache, drowsiness, weakness, irritability, hunger, fast heartbeat, confusion, shaking or feeling jittery, dizziness, or sweating.

Vaginal yeast infection. Women who take SYNJARDY 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 SYNJARDY 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 penis.

Low vitamin B12 (vitamin B12 deficiency). Using metformin for long periods of time may cause a decrease in the amount of vitamin B12 in your blood, especially if you have had low vitamin B12 blood levels before. Your doctor may do blood tests to check your vitamin B12 levels.

Increased fats in your blood (cholesterol).

The most common side effects of SYNJARDY include stuffy or runny nose and sore throat, urinary tract infections, female genital infections, diarrhea, headache, nausea, and vomiting.

These are not all the possible side effects of SYNJARDY. For more information, ask your doctor or pharmacist.

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 including Boxed Warning regarding the risk of lactic acidosis and Medication Guide.

SY CONS ISI 7.18.16

See More

WHAT IS SYNJARDY?

SYNJARDY is a prescription medicine that contains 2 diabetes medicines, empagliflozin (JARDIANCE) and metformin. SYNJARDY can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

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

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about SYNJARDY?

SYNJARDY can cause serious side effects, including Lactic Acidosis (a build-up of lactic acid in the blood). Metformin, one of the medicines in SYNJARDY, can cause lactic acidosis, a rare, but serious condition that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.

Call your doctor right away if you get any of the following symptoms of lactic acidosis: cold in your hands or feet; feel dizzy or lightheaded; slow or irregular heartbeat; feel very weak or tired; have unusual muscle pain; have trouble breathing; feel sleepy or drowsy; have stomach pains, nausea, or vomiting.

You have a higher chance of getting lactic acidosis with SYNJARDY if you: have moderate to severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye; have liver problems; drink alcohol very often, or drink a lot of alcohol in the short-term (“binge” drinking); get dehydrated (lose a large amount of body fluids); have surgery; have a heart attack, severe infection, or stroke.

Who should not take SYNJARDY?

Do not take SYNJARDY if you:

  • have moderate to severe kidney problems or are on dialysis
  • have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine)
  • are allergic to empagliflozin (JARDIANCE), metformin, or any of the ingredients in SYNJARDY. Symptoms of serious allergic reactions to SYNJARDY may include skin rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing. If you have any of these symptoms, stop taking SYNJARDY and contact your doctor or go to the nearest emergency room right away

What should I tell my doctor before using SYNJARDY?

Tell your doctor about all of your medical conditions, including if you:

  • have moderate to severe kidney problems. Your doctor may do blood tests to check your kidneys before and during treatment with SYNJARDY
  • have liver problems
  • have a history of urinary tract infection or problems with urination
  • have heart problems, including congestive heart failure
  • 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)
  • are going to get an injection of dye or contrast agents for an x-ray procedure. SYNJARDY may need to be stopped for a short time. Talk to your doctor about when you should stop SYNJARDY and when you should start SYNJARDY again
  • have type 1 diabetes. SYNJARDY should not be used in people with type 1 diabetes
  • are pregnant or planning to become pregnant. SNYJARDY may harm your unborn baby. Tell your doctor right away if you become pregnant while taking SYNJARDY
  • are a premenopausal woman (before the “change of life”), who does not have periods regularly or at all. Talk to your doctor about birth control choices while taking SYNJARDY as it may increase your chances of becoming pregnant
  • are breastfeeding or plan to breastfeed. SYNJARDY may pass into your breast milk and may harm your baby. Do not breastfeed while taking SYNJARDY.

Tell your doctor about all the medicines you take including prescription or over-the-counter medicines, vitamins, or herbal supplements.

What are the possible side effects of SYNJARDY?

SYNJARDY may cause serious side effects including:

Dehydration. SYNJARDY 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 higher risk of dehydration if you have low blood pressure, kidney problems, are 65 years of age or older, on a low salt diet, or take medicines to lower your blood pressure, including water pills (diuretics).

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 SYNJARDY, even if blood sugar is less than 250 mg/dL. Stop taking SYNJARDY and call your doctor right away if you get any of the following symptoms, and, if possible, check for ketones in your urine:

  • nausea
  • tiredness
  • vomiting
  • trouble breathing
  • stomach-area (abdominal) pain
  • nausea
  • vomiting
  • stomach-area (abdominal) pain
  • tiredness
  • trouble breathing

Serious urinary tract infections. Serious urinary tract infections can occur in people taking SYNJARDY 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.

Kidney problems. SYNJARDY can cause kidney problems, especially in people 75 years of age or older and people who already have kidney problems.

Low blood sugar (hypoglycemia). If you take SYNJARDY 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. Symptoms of low blood sugar may include headache, drowsiness, weakness, irritability, hunger, fast heartbeat, confusion, shaking or feeling jittery, dizziness, or sweating.

Vaginal yeast infection. Women who take SYNJARDY 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 SYNJARDY 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 penis.

Low vitamin B12 (vitamin B12 deficiency). Using metformin for long periods of time may cause a decrease in the amount of vitamin B12 in your blood, especially if you have had low vitamin B12 blood levels before. Your doctor may do blood tests to check your vitamin B12 levels.

Increased fats in your blood (cholesterol).

The most common side effects of SYNJARDY include stuffy or runny nose and sore throat, urinary tract infections, female genital infections, diarrhea, headache, nausea, and vomiting.

These are not all the possible side effects of SYNJARDY. For more information, ask your doctor or pharmacist.

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 including Boxed Warning regarding the risk of lactic acidosis and Medication Guide.

SY CONS ISI 7.18.16