SYNJARDY- empagliflozin and metformin hydrochloride tablet 
Boehringer Ingelheim Pharmaceuticals, Inc.

----------

This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised: June 2021      
MEDICATION GUIDE
SYNJARDY® (sin-JAR-dee)
(empagliflozin and metformin hydrochloride tablets)
for oral use
What is the most important information I should know about SYNJARDY?
SYNJARDY can cause serious side effects, including:
  • Lactic Acidosis. Metformin hydrochloride, one of the medicines in SYNJARDY, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.
    Stop taking SYNJARDY and call your doctor right away or go to the nearest hospital emergency room if you get any of the following symptoms of lactic acidosis:
  • feel very weak and tired
  • have unusual (not normal) muscle pain
  • have trouble breathing
  • have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea
  • have unusual sleepiness or sleep longer than usual
  • feel cold, especially in your arms and legs
  • feel dizzy or lightheaded
  • have a slow or irregular heartbeat
You have a higher chance of getting lactic acidosis with SYNJARDY if you:
  • have moderate to severe kidney problems.
  • have liver problems.
  • drink a lot of alcohol (very often or short-term "binge" drinking).
  • get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids.
  • have certain x-ray tests with injectable dyes or contrast agents.
  • have surgery or other procedure for which you need to restrict the amount of food and liquid you eat and drink.
  • have congestive heart failure.
  • have a heart attack, severe infection, or stroke.
  • are 65 years of age or older.
Tell your doctor if you have any of the problems in the list above. Tell your doctor that you are taking SYNJARDY before you have surgery or x-ray tests. Your doctor may need to stop your SYNJARDY for a while if you have surgery or certain x-ray tests. SYNJARDY can have other serious side effects. See "What are the possible side effects of SYNJARDY?"
  • Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 diabetes or type 2 diabetes, during treatment with empagliflozin, one of the medicines in SYNJARDY. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with SYNJARDY. Ketoacidosis is a serious condition, which needs to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with SYNJARDY even if your blood sugar is less than 250 mg/dL. Stop taking SYNJARDY and call your doctor right away or go to the nearest hospital emergency room if you get any of the following symptoms:
  • nausea
  • vomiting
  • stomach-area (abdominal) pain
  • tiredness
  • trouble breathing
If you get any of these symptoms during treatment with SYNJARDY, if possible, check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.
  • Dehydration. SYNJARDY can cause some people to become dehydrated (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). There have been reports of sudden worsening of kidney function in people who are taking SYNJARDY.
    You may be at higher risk of dehydration if you:
  • have kidney problems
  • are 65 years of age or older
  • are on low sodium (salt) diet
  • take medicines to lower your blood pressure, including diuretics (water pills)
Talk to your doctor about what you can do to prevent dehydration including how much fluid you should drink on a daily basis.
Talk to your doctor right away if you reduce the amount of food or liquid you drink, for example if you are sick or cannot eat, or start to lose liquids from your body, for example from vomiting, diarrhea or being in the sun too long.
What is SYNJARDY?
SYNJARDY is a prescription medicine that contains 2 diabetes medicines, empagliflozin (JARDIANCE) and metformin hydrochloride. SYNJARDY can be used:
  • along with diet and exercise to improve blood sugar in adults with type 2 diabetes,
  • in adults with type 2 diabetes who have known cardiovascular disease when empagliflozin (JARDIANCE), one of the medicines in SYNJARDY, is needed to reduce the risk of cardiovascular death.
  • SYNJARDY is not for people with type 1 diabetes. It may increase their risk of diabetic ketoacidosis (increased ketones in blood or urine).
  • It is not known if SYNJARDY is safe and effective in children.
Who should not take SYNJARDY?
Do not take SYNJARDY if you:
  • have severe kidney problems, end stage renal disease 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. See the end of this Medication Guide for a complete list of ingredients in SYNJARDY. Symptoms of a serious allergic reaction to SYNJARDY may include:
    • swelling of your face, lips, throat and other areas of your skin
    • difficulty with swallowing or breathing
    • raised, red areas on your skin (hives)
    If you have any of these symptoms, stop taking SYNJARDY and call your doctor right away or go to the nearest hospital emergency room.
What should I tell my doctor before taking SYNJARDY?
Before taking SYNJARDY, tell your doctor about all of your medical conditions, including if you:
  • have kidney problems.
  • have liver problems.
  • have heart problems, including congestive heart failure.
  • are 65 years of age or older.
  • have a history of infection of the vagina or penis.
  • have a history of urinary tract infection or problems with urination.
  • are going to have surgery. Your doctor may stop your SYNJARDY before you have surgery. Talk to your doctor if you are having surgery about when to stop taking SYNJARDY and when to start it again.
  • are eating less, or there is 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 the short term ("binge" drinking).
  • are going to get an injection of dye or contrast agents for an x-ray procedure. SYNJARDY may need to be stopped for a short time. Talk to your doctor about when you should stop SYNJARDY and when you should start SYNJARDY again. See "What is the most important information I should know about SYNJARDY?"
  • have type 1 diabetes. SYNJARDY should not be used to treat people with type 1 diabetes.
  • have low levels of vitamin B12 in your blood.
  • are pregnant or plan to become pregnant. SYNJARDY may harm your unborn baby. If you become pregnant while taking SYNJARDY, tell your doctor as soon as possible. Talk with your doctor about the best way to control your blood sugar while you are pregnant.
  • are breastfeeding or plan to breastfeed. SYNJARDY may pass into your breast milk and may harm your baby. Talk with your doctor about the best way to feed your baby if you are taking SYNJARDY. Do not breastfeed while taking SYNJARDY.
  • are a person who has not gone through menopause (premenopausal) who does not have periods regularly or at all. SYNJARDY can cause the release of an egg from an ovary in a person (ovulation). This can increase your chance of getting pregnant. Tell your doctor right away if you become pregnant while taking SYNJARDY.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
SYNJARDY may affect the way other medicines work, and other medicines may affect how SYNJARDY works.
Especially tell your doctor if you take:
  • insulin or other medicines that can lower your blood sugar
  • diuretics (water pills)
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
How should I take SYNJARDY?
  • Take SYNJARDY exactly as your doctor tells you to take it.
  • Take SYNJARDY by mouth 2 times each day with meals. Taking SYNJARDY with meals may lower your chance of having an upset stomach.
  • Your doctor may change your dose if needed.
  • If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take two doses of SYNJARDY at the same time. Talk with your doctor if you have questions about a missed dose.
  • Your doctor may tell you to take SYNJARDY along with other diabetes medicines. Low blood sugar can happen more often when SYNJARDY is taken with certain other diabetes medicines. See "What are the possible side effects of SYNJARDY?"
  • If you take too much SYNJARDY, call your doctor or go to the nearest hospital emergency room right away.
  • Your doctor will do blood tests to check how well your kidneys are working before and during your treatment with SYNJARDY.
  • When taking SYNJARDY, you may have sugar in your urine, which will show up on a urine test.
What should I avoid while taking SYNJARDY?
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.
What are the possible side effects of SYNJARDY?
SYNJARDY may cause serious side effects, including:
  • See "What is the most important information I should know about SYNJARDY?"
  • 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. 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 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 while you take SYNJARDY. Signs and symptoms of low blood sugar may include:
  • headache
  • drowsiness
  • weakness
  • irritability
  • hunger
  • fast heartbeat
  • confusion
  • shaking or feeling jittery
  • dizziness
  • sweating
  • A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in women and men who take empagliflozin, one of the medicines in SYNJARDY. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries, and may lead to death. Seek medical attention immediately if you have a fever or you are feeling very weak, tired or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals:
  • pain or tenderness
  • swelling
  • redness of skin (erythema)
  • Vaginal yeast infection. 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). Swelling of an uncircumcised penis may develop 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.
    Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis. Your doctor may suggest you use an over-the-counter antifungal medicine. Talk to your doctor right away if you use an over-the-counter antifungal medication and your symptoms do not go away.
  • Allergic (hypersensitivity) reactions. Serious allergic reactions have happened in people who are taking empagliflozin, one of the medicines in SYNJARDY. Symptoms may include:
    • swelling of your face, lips, throat and other areas of your skin
    • difficulty with swallowing or breathing
    • raised, red areas on your skin (hives)
    If you have any of these symptoms, stop taking SYNJARDY and call your doctor right away or go to the nearest hospital emergency room.
  • 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.
The most common side effects of SYNJARDY include:
  • low blood sugar
  • urinary tract infection
  • stuffy or runny nose and sore throat
  • yeast infections in females
  • diarrhea
  • nausea or vomiting
  • gas
  • stomach discomfort
  • indigestion
  • weakness
  • headache
These are not all the possible side effects of SYNJARDY. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store SYNJARDY?
  • Store SYNJARDY at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep SYNJARDY and all medicines out of the reach of children.
General information about the safe and effective use of SYNJARDY.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SYNJARDY for a condition for which it was not prescribed. Do not give SYNJARDY to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or doctor for information about SYNJARDY that is written for health professionals.
What are the ingredients in SYNJARDY?
Active Ingredients: empagliflozin and metformin hydrochloride
Inactive Ingredients: copovidone, corn starch, colloidal silicon dioxide, magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, talc, and polyethylene glycol 400. 5 mg/500 mg and 5 mg/1000 mg tablets also contain yellow ferric oxide. 12.5 mg/500 mg and 12.5 mg/1000 mg tablets also contain red ferric oxide and black ferrosoferric oxide

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc.; Ridgefield, CT 06877 USA
Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc.; Ridgefield, CT 06877 USA and Eli Lilly and Company, Indianapolis, IN 46285 USA
SYNJARDY is a registered trademark of and used under license from Boehringer Ingelheim International GmbH.
Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the Jardiance® and EMPA-REG OUTCOME® trademarks under license.
The other brands listed are trademarks of their respective owners and are not trademarks of Boehringer Ingelheim Pharmaceuticals, Inc.
Copyright © 2021 Boehringer Ingelheim International GmbH
ALL RIGHTS RESERVED
COL8974AF142021
For more information about SYNJARDY including current prescribing information and Medication Guide, go to www.synjardy.com, scan the code, or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.
Image

Revised: 6/2021
Boehringer Ingelheim Pharmaceuticals, Inc.