Synjardy (Empagliflozin / Metformin HCI)

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).

Directions

The recommended dose is one tablet twice daily. The dosage should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability using the recommended daily dose of 10 mg or 25 mg of empagliflozin, while not exceeding maximum recommended daily dose of metformin. Synjardy should be taken twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin. All patients should continue their diet with an adequate distribution of carbohydrate intake during the day. Overweight patients should continue their energy restricted diet. If a dose is missed, it should be taken as soon as the patient remembers. However, a double dose should not be taken on the same time. In that case, the missed dose should be skipped.

Ingredients

SYNJARDY is a combination of empagliflozin (Jardiance®) and metformin

Cautions

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

Side Effects

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

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.