Uses
What is Synjardy used for?
Synjardy (empagliflozin/metformin) is commonly used to help lower blood sugar levels in people with type 2 diabetes.
Synjardy is also used in people with type 2 diabetes and either heart disease or heart failure to reduce your chance of the following complications.
- Dying from heart problems
- Hospital admission for heart failure (people with heart failure)
Synjardy is not used to treat type 1 diabetes.
Synjardy may also be used for other conditions as determined by your healthcare provider.
How does Synjardy work (mechanism of action)?
Synjardy works in different ways to help keep your blood glucose (sugar) from getting too high.
- Synjardy decreases the amount of glucose your body absorbs from things you eat and drink.
- Synjardy reduces the amount of glucose that your liver makes.
- Synjardy also helps your body’s own insulin to work better. (Insulin is a hormone that helps your body use glucose as a source of energy.)
- Synjardy helps your body get rid of sugar when you pee.
- Synjardy lowers the risk of dying from heart problems and hospital admissions for heart failure by helping your body get rid of extra sugar, salt, and water.
How is Synjardy supplied (dosage forms)?
Synjardy is available in the following dosage forms that are taken by mouth.
- 5 mg empagliflozin/500 mg metformin oral tablets
- 5 mg empagliflozin/1000 mg metformin oral tablets
- 12.5 mg empagliflozin/500 mg metformin oral tablets
- 12.5 mg empagliflozin/1000 mg metformin oral tablets
- 5 mg empagliflozin/1000 mg metformin extended-release oral tablets
- 10 mg empagliflozin/1000 mg metformin extended-release oral tablets
- 12.5 mg empagliflozin/1000 mg metformin extended-release oral tablets
- 25 mg empagliflozin/1000 mg metformin extended-release oral tablets
How should I store Synjardy?
Synjardy oral tablets should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.
Side Effects
What are the most common side effects of Synjardy?
The most common side effects of Synjardy are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Kidney or bladder infections
- Yeast infection of the vagina or penis
- Diarrhea
- Nausea/vomiting
- Gas
- Stomach pain, upset stomach
- Feeling unusually weak or tired
- Headache
There may be other side effects of Synjardy that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Synjardy?
While less common, the most serious side effects of Synjardy are described below, along with what to do if they happen.
Severe Allergic Reactions. Synjardy may cause allergic reactions, which can be serious. Stop taking Synjardy and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Diabetic Ketoacidosis (DKA). Synjardy may cause diabetic ketoacidosis (a serious complication of diabetes). DKA can be life threatening. Stop taking Synjardy and get help right away if you have any of the following symptoms of diabetic ketoacidosis.
- Nausea/vomiting
- Stomach pain
- Feeling very tired, woozy, or confused
- Difficulty breathing
- Your breath smells fruity or sweet
- Very high blood sugar levels (>300 mg/dL)
Lactic Acidosis. Synjardy may cause lactic acidosis (a buildup of lactic acid in your blood), which can be serious. Stop using Synjardy and get help right away if you have any of the following symptoms of lactic acidosis.
- General ill feeling
- Muscle pain
- Difficulty breathing
- Drowsiness
- Stomach pain
Dehydration. Synjardy may cause dehydration. Dehydration may lead to low blood pressure, especially when you stand up (orthostatic hypotension), or kidney damage. Call your healthcare provider right away if you have any of the following symptoms of dehydration, low blood pressure, or kidney damage.
- Dizziness or lightheadedness
- Weakness or unusual tiredness
- Confusion
- Unsteadiness
- Peeing less than normal
- Swelling in your legs, ankles, and feet
- Loss of appetite/nausea
- Difficulty catching your breath or chest pain/pressure
- Seizures
- Extreme thirst
Urosepsis and Pyelonephritis. Synjardy may cause pyelonephritis (a kidney infection) or urosepsis (an untreated urinary tract infection that spreads to your kidney). These are serious infections and may need to be treated in the hospital. Get help right away if you have any of the following symptoms of these serious infections.
- Synjardy, cloudy, or bloody pee or pee that smells bad
- Fever and chills
- Loss of appetite
- Needing to pee a lot or feeling pain when you pee
- Pain in your lower back, side, or groin
- Upset stomach, nausea, and vomiting
Low Blood Sugar (Hypoglycemia). Synjardy can cause low blood sugar, especially when combined with insulin or other medicines that increase your insulin levels. Low blood sugar can be serious and may lead to death. You may need a lower dose of your other diabetes medicine to reduce your risk of hypoglycemia. Do not take Synjardy and call your healthcare provider right away if you have any of the following symptoms of hypoglycemia.
- Headache
- Crankiness or anxiety
- Hunger
- Dizziness or confusion
- Blurry vision
- Slurred speech
- Sweating
- Feeling jittery or shakiness
- Fast heartbeat
- Seizures
Necrotizing Fasciitis (Fournier’s Gangrene). Synjardy can cause necrotizing fasciitis (an aggressive skin and tissue infection that causes some of the tissue involved to die). Necrotizing fasciitis is rare, but very serious, can lead to death, and may require surgery to treat it. Get help right away if you have any of the following symptoms of this serious infection.
- Pain, redness, tenderness, or swelling of the perineum (of and around the anus and genitals)
- Fever
- General feeling of illness or discomfort
Vitamin B12 Deficiency. Synjardy may cause you to have low levels of vitamin B12 in your blood (possibly by decreasing the amount of vitamin B12 your body absorbs from things you eat or drink), which may lead to anemia (low levels of red blood cells). Your healthcare provider will likely use lab tests to check your vitamin B12 levels and for anemia. Tell your healthcare provider right away if you have any of the following symptoms of anemia.
- Unusual weakness or tiredness
- Cold hands and feet
- Fast or abnormal heartbeat
- Pale or yellowish skin
- Dizziness, lightheadedness, or feeling like you are about to pass out
- Shortness of breath
Amputations. People who take Synjardy may be more likely to have an amputation (limb or part of a limb cut off) than people who do not take Synjardy. The toe, part of the foot, or part of the leg were most often involved. Amputations seem more likely in people with diabetes, heart disease, peripheral artery disease (narrowing of your blood vessels, often in your legs), diabetic foot infections, nerve damage in your legs, or who already had an amputation. Inspect your feet and legs regularly and contact your healthcare provider right away if you have sores, ulcers, or new pain or tenderness, as these may lead to the need for an amputation if not treated.
Warnings & Precautions
Who should not use Synjardy?
Allergies to Ingredients. People who are allergic to any of the following should not take Synjardy.
- Empagliflozin
- Jardiance
- Metformin
- Glumetza
- Fortamet
- Any other medicine that contains metformin
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Synjardy.
Liver Problems. Synjardy should not be used if your liver is not working as well as it should be. If there is a concern about the health of your liver, your healthcare provider may do tests to determine if it is working well enough to take this medicine.
Kidney Problems. Synjardy should not be used if your kidneys are not working as well as they should be. If there is a concern about the health of your kidneys, your healthcare provider may do tests to determine if they are working well enough to take this medicine.
Metabolic Acidosis, Including Diabetic Ketoacidosis. Synjardy should not be used in people with acute or chronic metabolic acidosis. Tell your healthcare provider if you have a history of metabolic acidosis or diabetic ketoacidosis.
What should I know about Synjardy before using it?
Do not take Synjardy unless it has been prescribed to you by a healthcare provider. Take it as prescribed.
Do not share Synjardy with other people, even if they have the same condition as you. It may harm them.
Keep Synjardy out of the reach of children.
If you take Synjardy XR, you may sometimes notice something in your stool (poop) that looks like the tablet. This is normal and should not cause concern.
Do not chew, cut, or crush Synjardy XR tablets, they should be swallowed whole.
Synjardy can cause ovulation (release of an egg from your ovary) if you have not gone through menopause, even if you do not have regular periods. This can increase your chance of getting pregnant.
Certain conditions that cause increased stress on your body, like fever, trauma (such as a car accident), infection, or surgery can change the amount of diabetes medicines you need to take to control your diabetes. Talk to your healthcare provider if you have any of these conditions to decide if your medicine needs to be changed.
Talk to your healthcare provider about how to prevent, recognize, and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and diabetes-related problems.
People who are 65 years or older can be at greater risk for some side effects from Synjardy. Talk to your healthcare provider about your risks if you are in this age group.
People who have kidney problems can be at greater risk for some side effects from Synjardy. Talk to your healthcare provider about your risks if you have kidney problems.
Take Synjardy with food to help decrease the chance you will have an upset stomach.
Synjardy will cause your pee to test positive for glucose (sugar).
Your healthcare provider will run lab tests to see how well your kidneys are working and make sure you are not dehydrated before starting Synjardy.
What should I tell my healthcare provider before using Synjardy?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Synjardy is right for you.
In particular, make sure that you discuss any of the following.
Risk factors for diabetic ketoacidosis. Tell your healthcare provider if you have any of the following risk factors for diabetic ketoacidosis. Your healthcare provider may monitor you more closely or choose a different medicine for you.
- Type 1 diabetes or a history of diabetic ketoacidosis. Your healthcare provider may want you to monitor for ketones (acids made in your liver) if you are taking Synjardy.
- Decrease in your insulin dose
- Serious infection
- Low-salt diet. Your healthcare provider may suggest you stop using a low-salt diet.
- Ketogenic diet (high fat/low carbohydrate)
- Drink alcohol often or in large amounts
- Pancreas problems, including a history of pancreatitis or surgery on your pancreas.
- Dehydration
- Eating or drinking less than normal
- Vomiting or diarrhea
Risk factors for lactic acidosis. Tell your healthcare provider if you have any of the following risk factors for lactic acidosis. Your healthcare provider may monitor you more closely or choose a different medicine for you.
- Kidney problems
- Liver problems
- Heart problems, including congestive heart failure or a heart attack
- Drink alcohol often or in large amounts
- Have an upcoming medical test that uses contrast (a special dye), surgery, or other procedure
- Dehydration
- Severe infection
- Stroke
Previous amputation, nerve damage, or blood flow problems. Tell your healthcare provider if you had a previous amputation, or have nerve damage, or blood flow problems. You may be more likely to need a lower limb amputation with Synjardy. Your healthcare provider may choose a different medicine for you.
History of genital yeast infections. Tell your healthcare provider if you have a history of genital (penis or vagina) yeast infections. This may make it more likely that you will have yeast infections of the vagina or penis while taking Synjardy. Your healthcare provider may choose a different medicine for you.
History of kidney or bladder infections or difficulty peeing. Tell your healthcare provider about any kidney or bladder infections or if you have trouble peeing. Your healthcare provider may choose a different medicine for you.
Have surgery scheduled. Talk to your healthcare provider if you are having surgery so you know when to stop and restart your Synjardy.
Other Medicines and Supplements. Synjardy may interact with other medicines and supplements. Before taking Synjardy, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. Synjardy may cause harm to an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. If you become pregnant, contact your healthcare provider right away.
Breastfeeding. It is not known if Synjardy passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should stop breastfeeding or stop Synjardy.
How can I get more information about Synjardy?
For more information about Synjardy, you can visit the manufacturer’s website at https://patient.boehringer-ingelheim.com/us/products/synjardy/ or call them at 800-542-6257.
Interactions
Does Synjardy interact with foods or drinks?
There are no known interactions between Synjardy and foods or drinks.
Being on a low-salt diet while taking Synjardy may increase your risk of dehydration. See the Side Effects section for more details.
Drinking too much alcohol while taking Synjardy may increase your risk of diabetic ketoacidosis. See the Side Effects section for more details. It is unknown if drinking alcohol will affect Synjardy in other ways, but alcohol may affect blood sugar levels in people with diabetes. This may interfere with the effect of Synjardy. It is best to limit the amount of alcohol you drink.
Does Synjardy interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking Synjardy.
- Lithium, which is a medicine for certain mental health conditions
- A diuretic, also called a water pill, which is a medicine used to reduce edema (fluid retention) and blood pressure
- A carbonic anhydrase inhibitor, such as zonisamide (Zonegran), acetazolamide (Diamox), topiramate (Topamax), or methimazole
- Other medicines for diabetes
Some other medicines may alter the blood levels of Synjardy. Tell your healthcare provider about all medicines that you take or have recently taken.
Many other medicines can increase your blood sugar and can interfere with the effect of Synjardy. Talk to your pharmacist or healthcare provider before starting or stopping other medicines while taking Synjardy. You may need to monitor your blood sugar levels more closely during these times.
This may not be a complete list of medicines that can interact with Synjardy. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Synjardy?
If you or someone else has used too much Synjardy, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Synjardy?
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.
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