SYNJARDY or SYNJARDY XR is a prescription medicine that contains 2 diabetes medicines, empagliflozin (JARDIANCE) and metformin HCl. SYNJARDY can be used along with diet and exercise to improve blood sugar in adults and children who are 10 years of age and older with type 2 diabetes. SYNJARDY XR can be used along with diet and exercise to improve blood sugar in adults with type 2 diabetes.
One of the medicines in SYNJARDY and SYNJARDY XR, empagliflozin (JARDIANCE), can also be used in adults with type 2 diabetes:
SYNJARDY or SYNJARDY XR is not for use to lower blood sugar in people with type 1 diabetes. It may increase their risk of diabetic ketoacidosis (increased ketones in the blood or urine).
SYNJARDY or SYNJARDY XR is only for use in people with type 2 diabetes, because they contain the prescription medicine metformin hydrochloride (HCl).
SYNJARDY or SYNJARDY XR can cause serious side effects, including:
Lactic acidosis (a build‐up of lactic acid in the blood). Metformin HCl, one of the medicines in SYNJARDY and SYNJARDY XR, 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.
Stop taking SYNJARDY or SYNJARDY XR and call your healthcare provider right away or go to the nearest hospital emergency room if you get any of the following symptoms of lactic acidosis: feel very weak and tired; have unusual (not normal) muscle pain; have trouble breathing; have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea; have unusual sleepiness or sleep longer than usual; feel cold, especially in your arms and legs; feel dizzy or lightheaded; have a slow or irregular heartbeat.
You have a higher chance of getting lactic acidosis with SYNJARDY or SYNJARDY XR if you: have moderate to severe kidney problems; have liver problems; drink a lot of alcohol (very often or short term “binge” drinking); get dehydrated (lose a large amount of body fluids); have certain x-ray tests with injectable dyes or contrast agents; have surgery or other procedure for which you need to restrict the amount of food and liquid you eat and drink; have congestive heart failure; have a heart attack, severe infection, or stroke, or are 65 years of age or older.
Do not take SYNJARDY or SYNJARDY XR if you:
If you have any of these symptoms, stop taking SYNJARDY or SYNJARDY XR and call your healthcare provider right away or go to the nearest hospital emergency room.
SYNJARDY or SYNJARDY XR may cause serious side effects, including:
Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 and other ketoacidosis. SYNJARDY or SYNJARDY XR can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition which needs to be treated in a hospital. People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis. Ketoacidosis can also happen in people who: are sick, cannot eat or drink as usual, skip meals, are on a diet high in fat and low in carbohydrates (ketogenic diet), take less than the usual amount of insulin or miss insulin doses, drink too much alcohol, have a loss of too much fluid from the body (volume depletion), or who have surgery. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. Your healthcare provider may ask you to periodically check ketones in your urine or blood. Stop taking SYNJARDY or SYNJARDY XR and call your healthcare provider right away or go to the nearest hospital emergency room if you get any of the following symptoms. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL:
Dehydration. SYNJARDY or SYNJARDY XR can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up. Sudden worsening of kidney function has happened in people who are taking SYNJARDY or SYNJARDY XR. You may be at higher risk of dehydration if you:
Talk to your healthcare provider about what you can do to prevent dehydration, including how much fluid you should drink on a daily basis. Call your healthcare provider right away if you reduce the amount of food or liquid you drink, if you are sick or cannot eat, or start to lose liquids from your body from vomiting, diarrhea or being in the sun too long.
Vaginal yeast infection. Talk to your healthcare provider if you have vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), and/or vaginal itching.
Yeast infection of the skin around the penis. Swelling of an uncircumcised penis may develop that makes it difficult to pull back the skin around the tip of the penis. Talk to your healthcare provider if you have 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.
Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis. Your healthcare provider may suggest you use an over-the-counter antifungal medicine. Talk to your healthcare provider right away if you use an over-the-counter antifungal medication and your symptoms do not go away.
Serious urinary tract infections. Serious urinary tract infections can occur in people taking empagliflozin, one of the medicines in SYNJARDY and SYNJARDY XR, and may lead to hospitalization. Tell your healthcare provider 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). In adults, if you take SYNJARDY or SYNJARDY XR with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. In children who are 10 years of age and older, the risk for low blood sugar is higher with SYNJARDY even if you do not use another medicine that can lower blood sugar. 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.
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 people who take SYNJARDY or SYNJARDY XR, and may lead to hospitalization, multiple surgeries, and death. Seek medical attention immediately if you have a 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).
Amputations. SGLT2 inhibitors may increase your risk of lower limb amputations. You may be at higher risk of lower limb amputation if you:
Call your healthcare provider right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Talk to your healthcare provider about proper foot care.
Serious allergic reactions: If you have any symptoms of a serious allergic reaction, stop taking SYNJARDY or SYNJARDY XR and call your healthcare provider right away or go to the nearest emergency room.
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 healthcare provider may do blood tests to check your vitamin B12 levels.
The most common side effects of SYNJARDY or SYNJARDY XR include urinary tract infections, female genital infections, diarrhea, nausea, vomiting, gas, stomach pain, indigestion, weakness, headache, and stuffy or runny nose and sore throat.
These are not all the possible side effects of SYNJARDY or SYNJARDY XR. For more information, ask your healthcare provider or pharmacist.
Before taking SYNJARDY or SYNJARDY XR, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription or over‐the‐counter medicines, vitamins, or herbal supplements.
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.
Please see Prescribing Information and Medication Guide for SYNJARDY and SYNJARDY XR.
CL-SY-100080 10.30.23