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IMPORTANT SAFETY INFORMATION

SYNJARDY and SYNJARDY XR can cause serious side effects, including:

Lactic acidosis (a build-up of lactic acid in the blood). Metformin hydrochloride, 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 and 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:

• have severe kidney problems, end stage renal disease, 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 or SYNJARDY XR

SYNJARDY or SYNJARDY XR may cause serious side effects, including:

Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis is a serious condition, which needs 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 or SYNJARDY XR, even if blood sugar is less than 250 mg/dL. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with SYNJARDY or SYNJARDY XR. 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, and, if possible, check for ketones in your urine:

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

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

Talk to your healthcare provider about what you can do to prevent dehydration, including how much fluid you should drink on a daily basis, and 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.

Serious urinary tract infections. Serious urinary tract infections can occur in people taking SYNJARDY or 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). 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. 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 women and men 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).

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 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 penis.

Allergic (hypersensitivity) reactions: Symptoms of serious allergic reactions to SYNJARDY or SYNJARDY XR may include swelling of your face, lips, throat, and other areas of your skin, difficulty with swallowing or breathing, and raised, red areas on your skin (hives). If you have any of these symptoms, stop taking SYNJARDY or SYNJARDY XR and contact your healthcare provider or go to the nearest emergency room right away.

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:

• have kidney problems
• have liver problems
• have heart problems, including congestive heart failure
• are 65 years of age or older
• have a history of infection of the vagina or penis
• have a history of urinary tract infection or problems with urination
• are going to have surgery. Your healthcare provider may stop your SYNJARDY or SYNJARDY XR before you have surgery. Talk to your healthcare provider about when to stop taking SYNJARDY or SYNJARDY XR if you are having surgery and when to start it again
• are eating less or there is 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 or SYNJARDY XR may need to be stopped for a short time. Talk to your healthcare provider about when you should stop SYNJARDY or SYNJARDY XR and when you should start SYNJARDY or SYNJARDY XR again
• have type 1 diabetes. SYNJARDY or SYNJARDY XR should not be used in people with type 1 diabetes
• have low levels of vitamin B₁₂ in your blood
• are pregnant or plan to become pregnant. SYNJARDY or SYNJARDY XR may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking SYNJARDY or SYNJARDY XR
• are breastfeeding or plan to breastfeed. SYNJARDY or SYNJARDY XR may pass into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you are taking SYNJARDY or SYNJARDY XR. Do not breastfeed while taking SYNJARDY
• are a person who has not gone through menopause (premenopausal), who does not have periods regularly or at all. SYNJARDY or SYNJARDY XR can cause the release of an egg from an ovary in a person (ovulation). This can increase your chance of getting pregnant

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.
Please see Prescribing Information and Medication Guide for SYNJARDY XR.

CL-SY-100072 02.07.2023