Synjardy XR

Synjardy XR is a prescription medication used to treat type 2 diabetes. It is a single product containing 2 medications: empagliflozin and metformin.

Empagliflozin belongs to a group of drugs called sodium-glucose cotransporter 2 (SGLT2) inhibitors. These drugs work by stopping the reabsorption of glucose by the kidney, increasing glucose excretion from the body, and lowering blood sugar levels. Metformin belongs to a group of drugs called biguanides. These drugs work by helping your body respond better to the insulin it makes naturally, decreasing the amount of sugar your liver makes and decreasing the amount of sugar your intestines absorb.

This medication comes in tablet form and is taken once daily with a meal in the morning.

Swallow the tablet whole; do not split, crush, dissolve, or chew.

Common side effects include diarrhea, nausea/vomiting, gas, stomach discomfort, indigestion, weakness, and headache. Synjardy XR may also cause urinary tract infections and female genital yeast infections.

Synjardy XR can also cause low blood sugar, which can cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how Synjardy XR affects you.

Synjardy XR is a prescription medication used to treat type 2 diabetes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Boehringer Ingelheim

• Eli Lilly and Company

Serious side effects have been reported with Synjardy XR. See the “Synjardy XR Precautions” section.

Common side effects of Synjardy XR include the following:

• diarrhea
• nausea/vomiting
• gas
• stomach discomfort
• indigestion
• weakness
• headache
• urinary tract infections
• female genital yeast infections

This is not a complete list of Synjardy XR side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• beta-blockers such as metoprolol (Toprol XL, Lopressor), carvedilol (Coreg), bisoprolol (Zebeta), betaxolol (Kerlone), nebivolol (Bystolic), propranolol (Inderal)
• cough and cold products containing decongestants
• calcium channel blockers
• cimetidine (Tagamet)
• corticosteroids
• digoxin (Lanoxin)
• certain diuretics such as acetazolamide (Diamox), amiloride (Midamor), bumetanide (Bumex), chlorothiazide (Diuril),                                                                                                                                                       chlorthalidone, ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide, HCTZ), metolazone (Zaroxolyn), or torsemide (Demadex)
• estrogens
• Insulin or insulin-releasing drugs that can lower blood sugar such as glipizide (Glucotrol), glimepiride (Amaryl), repaglinide (Prandin), and nateglinide (Starlix)
• isoniazid (INH, Nydrazid)
• morphine
• niacin (nicotinic acid, Niaspan)
• nifedipine
• oral contraceptives
• oral steroids
• phenothiazines such as promethazine (Phenergan)
• phenytoin (Dilantin)
• procainamide
• quinidine
• quinine
• ranitidine
• thyroid medicines such as levothyroxine (Levothroid, Levoxyl, Synthroid)
• triamterene
• trimethoprim
• vancomycin

This is not a complete list of Synjardy XR drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Synjardy XR including the following:

• Lactic acidosis. Rarely, metformin can cause a serious side effect called lactic acidosis. This is caused by a buildup of lactic acid in your blood. This build-up can cause serious damage. Make sure you tell your doctor before you use metformin if you have kidney or liver problems. Lactic acidosis is a medical emergency that must be treated in a hospital. You should also stop using metformin and call your doctor right away if you have signs of lactic acidosis including:
  • feeling very weak, tired, or uncomfortable
  • unusual muscle pain
  • trouble breathing
  • unusual or unexpected stomach discomfort
  • feeling cold
  • feeling dizzy or lightheaded
  • suddenly developing a slow or irregular heartbeat
• Dehydration. This medication 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 (orthostatic hypotension). You may be at higher risk of dehydration if you:
  • have low blood pressure
  • are on low sodium (salt) diet
  • have kidney problems o are 65 years of age or older
  • take medicines to lower your blood pressure, including diuretics (water pill)
• Decreased blood pressure (hypotension). Tell your healthcare provider right away if you have some or all of the following symptoms of low blood pressure.
  • dizziness or lightheadedness
  • fainting (syncope)
  • lack of concentration
  • blurred vision
  • nausea
  • cold, clammy, pale skin
  • rapid, shallow breathing
  • fatigue
  • depression
  • thirst
• Impaired renal function. Changes in kidney function can occur with Synjardy XR, especially in people older than 75 years of age and those with existing kidney problems.
• Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type diabetes or type 2 diabetes, during treatment with empagliflozin, one of the medicines in. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with Synjardy XR even if your blood sugar is less than 250 mg/dL. Stop taking Synjardy XR and call your doctor right away if you get any of the following symptoms:
  • nausea
  • tiredness
  • vomiting
  • trouble breathing
  • stomach-area (abdominal) pain If you get any of these symptoms during treatment with Synjardy XR, if possible, check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.
• Kidney problems. Sudden kidney injury has happened to people taking Synjardy XR. Talk to your doctor right away if you: o reduce the amount of food or liquid you drink for example, if you are sick or cannot eat or o you start to lose liquids from your body for example, from vomiting, diarrhea or being in the sun too long
• Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking empagliflozin, one of the medicines in Synjardy XR. Tell your doctor if you have any signs or symptoms of a urinary tract infection such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (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 this medication with another medicine that can cause low blood sugar, your risk of getting low blood sugar is higher. The dose of your other medicine may need to be lowered while you take this medication. Signs and symptoms of low blood sugar may include:
  • headache
  • irritability
  • confusion
  • dizziness/drowsiness
  • hunger
  • shaking or feeling jittery
  • sweating
  • weakness
  • fast heartbeat
• Vaginal yeast infection. Women who take this medication may get vaginal yeast infections. Symptoms of a vaginal yeast infection include vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching.
• Yeast infection of the penis (balanitis). Men who take this medication may get a yeast infection of the skin around the penis. Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include redness, itching, or swelling of the penis, rash of the penis, foul-smelling discharge from the penis, or pain in the skin around the 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)

Synjardy XR can cause low blood sugar, which can cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how Synjardy XR affects you.

Avoid drinking alcohol very often, or drinking a lot of alcohol in a short period of time (“binge” drinking). It can increase your chances of getting serious side effects.

Do not take Synjardy XR if you:

• are allergic to Synjardy XR or to any of its ingredients
• have serious kidney problems or are on dialysis
• have metabolic acidosis or diabetic ketoacidosis

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Synjardy XR, there are no specific foods that you must exclude from your diet when receiving this medication.

Alcohol in combination with metformin may increase the risk of developing lactic acidosis. Avoid excessive alcohol use while taking Synjardy XR. Contact your doctor or pharmacist if you have any questions regarding alcohol use and Synjardy XR. 

Before taking Synjardy XR, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Synjardy XR or to any of its ingredients
• have kidney problems
• have liver problems
• have a history of urinary tract infection or problems with urination
• have heart problems, including congestive heart failure
• are going to have surgery
• are eating less due to illness, surgery, or 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 short-term “binge” drinking
• are going to get an injection of dye or contrast agents for an x-ray procedure.
• have a history of urinary tract infections or problems with urination
• have type 1 diabetes. Synjardy XR should not be used to treat people with type 1 diabetes.
• have any other medical conditions
• are pregnant or plan to become pregnant 
• are a premenopausal woman (before the “change of life”), who does not have periods regularly or at all if you are not planning to become pregnant. This is because this medication may increase your chance of becoming pregnant.
• are breastfeeding or plan to breastfeed 

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. 

There are no well-controlled studies that have been done in pregnant women. Synjardy XR may cause harm to your unborn baby. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Synjardy XR crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. It is not recommended when breastfeeding.  

• Take Synjardy XR exactly as prescribed.
• Synjardy XR comes in tablet form and is taken once daily with a meal in the morning. 
• Take this medication with food to reduce the risk of stomach upset.
• Swallow the tablet whole; do not split, crush, dissolve, or chew.
• You may see something that looks like the Synjardy XR tablet in your stool (bowel movement). If you see tablets in your stool talk to your doctor. Do not stop taking SYNJARDY XR without talking to your doctor.
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take 2 doses of Synjardy XR at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• how your kidneys work
• your age

The maximum recommended total daily dose is 25 mg empagliflozin and 2000 mg metformin hydrochloride.

If you take too much Synjardy XR, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Synjardy XR at room temperature. 
• Keep this and all medicines out of reach of children. 

WARNING: LACTIC ACIDOSIS

• Lactic acidosis is a rare, but serious, complication that can occur due to metformin accumulation. The risk increases with conditions such as renal impairment, sepsis, dehydration, excess alcohol intake, hepatic impairment, and acute congestive heart failure.
• The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress.
• Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate.
• If acidosis is suspected, Synjardy XR should be discontinued and the patient should be hospitalized immediately.