Synjardy contains a combination of empagliflozin and metformin. Empagliflozin and metformin are oral diabetes medicines that help control blood sugar levels. Empagliflozin works by helping the kidneys get rid of glucose from your bloodstream. Metformin lowers glucose production in the liver and also causes your intestines to absorb less glucose.

Synjardy is used together with diet and exercise to improve blood sugar control in patients aged 10 years and older with type 2 diabetes mellitus.

Synjardy is also used to lower the risk of death from heart attack, stroke, or heart failure in adults with type 2 diabetes who also have heart disease.

Synjardy is not for treating type 1 diabetes.

Synjardy may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or irregular heartbeats, dizziness, or feeling very weak or tired.

Tell your doctor if you are sick with vomiting or diarrhea, or if you eat or drink less than usual.

In rare cases, this medicine can cause serious infections in the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or if you don't feel well.

You should not use Synjardy if you have moderate to severe kidney disease, if you are on dialysis, or diabetic ketoacidosis (call your doctor for treatment).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking Synjardy.

Take Synjardy exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Take with meals.

Swallow the Synjardy extended-release tablet whole and do not crush, chew, break, or dissolve it. Tell your doctor if you have trouble swallowing the tablet.

Your blood sugar will need to be checked often, and you may also need to test the level of ketones in your urine. Empagliflozin can cause life-threatening ketoacidosis (too much acid in the blood). Even if your blood sugar is normal, contact your doctor if a urine test shows that you have high ketones in the urine.

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injection in case of severe hypoglycemia.

You may get dehydrated during prolonged illness. Call your doctor if you are sick with vomiting or diarrhea, or if you eat or drink less than usual.

Tell your doctor if you have a planned surgery.

Synjardy can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.

Your doctor may have you take extra vitamin B12 while you are taking Synjardy. Take only the amount of vitamin B12 your doctor has prescribed.

Your treatment may also include diet, exercise, weight control, and special medical care.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Diabetes Type 2:

Individualize dosage based on patient's current regimen

Synjardy Immediate-Release:
For Patients Already on Metformin:
-Initial dose: Switch to empagliflozin 10 mg/day plus similar total daily dose of metformin; give in 2 equally divided doses orally twice a day
For Patients Already on Empagliflozin:
-Initial dose: Switch to empagliflozin at the same total daily dose plus metformin 1000 mg/day; give in 2 equally divided doses orally twice a day
Patients Already on Synjardy:
-Initial dose: Switch to same total daily dose of each component (or nearest appropriate dose of metformin); give in 2 equally divided doses orally twice a day
Maintenance: Adjust dose based on efficacy and tolerability; a gradual dose escalation of metformin will help to reduce gastrointestinal side effects
Maximum dose: empagliflozin: 25 mg/day; metformin: 2000 mg/day

Synjardy Extended-Release::
For Patients Already on Metformin:
-Initial dose: Switch to empagliflozin 10 mg plus similar total daily dose of metformin orally once a day
For Patients Already on Empagliflozin:
-Initial dose: Switch to empagliflozin at the same total daily dose plus metformin 1000 mg/day orally once a day
Patients Already on Synjardy:
-Initial dose: Switch to same total daily dose of each component (or nearest appropriate dose of metformin) orally once a day
Maintenance: Adjust dose based on efficacy and tolerability; a gradual dose escalation of metformin will help to reduce gastrointestinal side effects.
Maximum dose: empagliflozin: 25 mg/day; metformin: 2000 mg/day.

Dosing information

Usual Adult Dose for Cardiovascular Risk Reduction:

Individualize dosage based on patient's current regimen

Synjardy Immediate-Release:
For Patients Already on Metformin:
-Initial dose: Switch to empagliflozin 10 mg/day plus similar total daily dose of metformin; give in 2 equally divided doses orally twice a day
For Patients Already on Empagliflozin:
-Initial dose: Switch to empagliflozin at the same total daily dose plus metformin 1000 mg/day; give in 2 equally divided doses orally twice a day
Patients Already on Synjardy:
-Initial dose: Switch to same total daily dose of each component (or nearest appropriate dose of metformin); give in 2 equally divided doses orally twice a day
Maintenance: Adjust dose based on efficacy and tolerability; a gradual dose escalation of metformin will help to reduce gastrointestinal side effects
Maximum dose: empagliflozin: 25 mg/day; metformin: 2000 mg/day

Synjardy Extended-Release:
For Patients Already on Metformin:
-Initial dose: Switch to empagliflozin 10 mg plus similar total daily dose of metformin orally once a day
For Patients Already on Empagliflozin:
-Initial dose: Switch to empagliflozin at the same total daily dose plus metformin 1000 mg/day orally once a day
Patients Already on Synjardy:
-Initial dose: Switch to same total daily dose of each component (or nearest appropriate dose of metformin) orally once a day
Maintenance: Adjust dose based on efficacy and tolerability; a gradual dose escalation of metformin will help to reduce gastrointestinal side effects.
Maximum dose: empagliflozin: 25 mg/day; metformin: 2000 mg/day

Comments:
-When used in combination with insulin or an insulin secretagogue, a lower dose of insulin or insulin secretagogue should be considered to reduce the risk of hypoglycemia.
-Assess renal function; correct volume depletion prior to beginning therapy.

Uses:
-As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
-Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.

You should not use Synjardy if you are allergic to empagliflozin or metformin, or if you have:

• severe kidney disease (or if you are on dialysis); or

• metabolic acidosis or diabetic ketoacidosis (call your doctor for treatment).

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking this medicine. Be sure your caregivers know ahead of time that you are using Synjardy.

To make sure Synjardy is safe for you, tell your doctor if you have:

• liver or kidney disease;

• a bladder infection or urination problems;

• congestive heart failure, a heart attack or stroke;

• a genital infection (penis or vagina);

• problems with your pancreas, including surgery;

• if you are on a low salt diet; or

• if you are 65 or older.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Ask your doctor about your risk.

Follow your doctor's instructions about using Synjardy if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy.

You should not use Synjardy during the second or third trimester of pregnancy.

Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

Do not breastfeed while using Synjardy.

Not approved for use by anyone younger than 18 years old.

Take the medicine (with food) as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause lactic acidosis. Symptoms may include unusual muscle pain, trouble breathing, irregular heartbeats, or if you feel very weak.

Avoid drinking alcohol. It may increase your risk of lactic acidosis.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Get emergency medical help if you have signs of an allergic reaction to Synjardy: hives; trouble swallowing, difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical attention right away if you have signs of a serious genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well. These symptoms may get worse quickly.

Stop taking Synjardy and call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• dehydration - dizziness, confusion, feeling very thirsty, less urination;

• ketoacidosis (too much acid in the blood) - nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing;

• lactic acidosis - unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired; or

• signs of a bladder infection - pain or burning when you urinate, blood in your urine, pain in pelvis or back.

Some side effects may be more likely to occur in older adults.

Common Synjardy side effects may include:

• low blood sugar;

• indigestion, stomach pain, gas, nausea, vomiting, diarrhea;

• a bladder infection;

• yeast infection in women (vaginal itching or discharge);

• headache, weakness; or

• runny or stuffy nose, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may increase or decrease the effects of Synjardy on lowering your blood sugar. Tell your doctor about all your current medicines and any you start or stop using, especially:

• insulin, or other oral diabetes medicine; or

• a diuretic or "water pill."

This list is not complete. Other drugs may interact with empagliflozin and metformin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.