Synjardy - Consumer Medicine Information
|Manufacture:||Boehringer Ingelheim Pharmaceuticals, Inc.|
|Condition:||Diabetes, Type 2|
|Ingredients:||eempagliflozin, metformin hydrochloride, 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|
(empagliflozin and metformin hydrochloride)
What is the most important information I should know about SYNJARDY
SYNJARDY can cause serious side effects, including:
Lactic Acidosis. Metformin, 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 if you get any of the following symptoms of lactic acidosis
- you feel very weak or tired
- you have unusual (not normal) muscle pain
- you have trouble breathing
- you have unusual sleepiness or sleep longer than usual
- you have stomach pains, nausea and vomiting or diarrhea
- you feel cold, especially in your arms and legs
- you feel dizzy or lightheaded
- you have a slow or irregular heartbeat
You have a higher chance of getting lactic acidosis with SYNJARDY if you
- have kidney problems or your kidneys are affected by injectable dyes used for certain x-ray tests. People whose kidneys are not working properly should not take SYNJARDY.
- have liver problems
- have congestive heart failure that requires treatment with medicines
- drink alcohol very often, or drink a lot of alcohol in the 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 surgery
- have a heart attack, severe infection, or stroke
- are 80 years of age or older and have not had your kidneys tested
SYNJARDY can have other serious side effects. See “What are the possible side effects of SYNJARDY?”
Who should not take SYNJARDY
Do not take SYNJARDY if you
- have severe kidney problems or are on dialysis
- have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine)
- are allergic to empagliflozin, metformin, or any of the ingredients in SYNJARDY. See the end of this Medication Guide for a list of ingredients in SYNJARDY.
What should I tell my doctor before using SYNJARDY
Before taking SYNJARDY, tell your healthcare provider about all of your medical conditions, including if you
- 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 the short term (“binge” drinking)
- are going to get an injection of dye or contrast agents for an x-ray procedure. SYNJARDY will 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 a history of urinary tract infections or problems with urination
- have type 1 diabetes. SYNJARDY should not be used to treat people with type 1 diabetes. have any other medical conditions
- are pregnant or planning to become pregnant. It is not known if SYNJARDY will harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant.
- are breastfeeding or plan to breastfeed. It is not known if SYNJARDY passes into your breast milk. Talk with your doctor about the best way to feed your baby if you take SYNJARDY.
Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements.
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 will tell you how much SYNJARDY to take and when to take it. 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.
- When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine that you need may change. Tell your doctor right away if you have any of these conditions and follow your doctor’s instructions.
- Check your blood sugar as your doctor tells you to.
- When taking SYNJARDY, you may have sugar in your urine, which will show up on a urine test. Stay on your prescribed diet and exercise program while taking SYNJARDY.
- Talk to your doctor about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and complications of diabetes.
- Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C. Your doctor will do blood tests to check how well your kidneys are working before and during your treatment with
- Your doctor may do certain blood tests before you start SYNJARDY and during treatment.
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?”
- Dehydration. SYNJARDY 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
- 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 pill)
- 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 can be life-threatening and may need to be treated in a hospital. 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 if you get any of the following symptoms:
- stomach-area (abdominal) pain
- 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.
- 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:
- shaking or feeling jittery
- fast heartbeat
- Kidney problems, especially in people 75 years of age or older and people who already have kidney problems
- Vaginal yeast infection. Women who take SYNJARDY 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 SYNJARDY 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.
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.
- 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).
The most common side effects of SYNJARDY include stuffy or runny nose and sore throat.
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).
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.
This Medication Guide summarizes the most important information about SYNJARDY. If you would like more information, talk with your doctor. You can ask your pharmacist or healthcare provider for information about SYNJARDY that is written for health professionals.
What are the ingredients in SYNJARDY
Eempagliflozin and metformin hydrochloride.
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.
For more information about SYNJARDY
go to www.synjardy.com
scan the adjacent code
or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or (TTY) 1-800-459-9906.