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Generic Name: empagliflozin and metformin (EM pa gli FLOE zin and met FOR min)
Brand Names: Synjardy

What is Synjardy?

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 adults with type 2 diabetes.

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.

Important information

You should not use Synjardy if you have moderate to severe kidney disease, if you are on dialysis, or in a state of diabetic ketoacidosis (call your doctor for treatment). Synjardy is not for treating type 1 diabetes.

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

This medicine 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 uneven heart rate, dizziness, or feeling very weak or tired.

Before taking this medicine

You should not use Synjardy if you are allergic to empagliflozin (Jardiance, Glyxambi) or metformin (Glucophage, Actoplus Met, Avandamet, Fortamet, Glucovance, Janumet, Jentadueto, Kazano, Kombiglyze, Metaglip, PrandiMet, Riomet), or if you have:

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

  • if you are in a state of 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 will need to temporarily stop taking Synjardy.

Some people taking metformin develop a serious condition called lactic acidosis. This may be more likely if you have liver or kidney disease, congestive heart failure, a severe infection, if you are dehydrated, or if you drink large amounts of alcohol. Talk with your doctor about your risk.

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

  • liver or kidney disease;

  • low blood pressure;

  • a history of bladder infections or urination problems;

  • high cholesterol levels;

  • a history of heart attack or stroke;

  • if you are on a low-salt diet;

  • if you take blood pressure medicine such as a diuretic (water pill); or

  • if you are 65 or older and your kidneys have not been tested.

It is not known whether Synjardy will harm an unborn baby. Tell your doctor if you are pregnant or if you become pregnant while taking Synjardy.

It is not known whether empagliflozin and metformin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking Synjardy.

Synjardy is not approved for use by anyone younger than 18 years old.

How should I take Synjardy?

Take Synjardy exactly as it was prescribed for you. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Your doctor may perform kidney function tests before you start taking Synjardy.

Take Synjardy with food to prevent upset stomach.

Do not crush, chew, or break a Synjardy extended-release tablet. Swallow the tablet whole.

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

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking Synjardy, which can lead to severely low blood pressure or a serious electrolyte imbalance.

Your blood sugar will need to be checked often, and you may also need to test the level of ketones 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 ketones in the urine.

Synjardy can cause positive results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using this medicine.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Synjardy is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Store Synjardy at room temperature, away from moisture and heat.

Synjardy dosing information

Usual Adult Dose for Diabetes Type 2:

Individualize dosage based on patient's current regimen; Total daily dose should be given orally in 2 equally divided doses with meals

Patients on metformin:
-Initial dose: empagliflozin 10 mg plus similar total daily dose of metformin divided orally twice a day
Patients on empagliflozin:
-Initial dose: empagliflozin at the same total daily dose plus metformin 500 mg/day divided orally twice a day
Patients on Synjardy:
-Initial dose: same total daily dose of each component (or nearest appropriate dose of metformin) divided 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

-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.
-Correct volume depletion prior to beginning this drug.

Use: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus when treatment with both Synjardy is appropriate.

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take the medicine with food). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

An overdose of metformin may cause lactic acidosis. Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.

What should I avoid while taking Synjardy?

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis while taking Synjardy.

Synjardy side effects

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

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have:

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

  • dehydration symptoms - feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

  • signs of a kidney problem - little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath;

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

  • signs of a bladder infection - pain or burning when you urinate, urine that looks cloudy, pain in pelvis or back; or

  • signs of a genital infection (penis or vagina) - pain, burning, itching, rash, redness, odor, or discharge.

Side effects may be more likely to occur in older adults.

Common Synjardy side effects may include:

  • bladder infection or genital infection;

  • headache;

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

  • weakness; or

  • cold symptoms such as stuffy nose, sneezing, 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.

See also: Side effects (in more detail)

What other drugs will affect Synjardy?

Sometimes it is not safe to use certain medications at the same time. Certain drugs can increase your risk of lactic acidosis or low blood sugar when used together with Synjardy. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about Synjardy.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Synjardy only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2017 Cerner Multum, Inc. Version: 1.04. Revision Date: 2017-01-06, 10:51:08 AM.