Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Jardiance (Empagliflozin)..

Diabetic ketoacidosis (DKA): Jardiance (Empagliflozin) has been associated with DKA. This is a potentially life-threatening condition caused by not having enough insulin in the blood to use the glucose in the bloodstream. When this happens, the body starts to burn ketones for fuel and can make the blood acidic. This condition is more likely to develop if you are following a very low carbohydrate diet, are dehydrated, or have consumed a large amount of alcohol. Symptoms of DKA include:

• difficulty breathing
• nausea
• vomiting
• abdominal pain
• confusion
• loss of appetite
• excessive thirst
• unusual fatigue or sleepiness

If you experience these symptoms, get immediate medical help.

Drowsiness/reduced alertness: Jardiance (Empagliflozin) may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how Jardiance (Empagliflozin) affects you.

Fluid and electrolyte balance: Jardiance (Empagliflozin) causes increased urine production that may cause the levels of electrolytes such as potassium, sodium, magnesium, chloride, and calcium in the blood to change while taking Jardiance (Empagliflozin). If you experience symptoms of fluid and electrolyte imbalance such as muscle pains or cramps; Dry Mouth; numb hands, feet, or lips; or racing heartbeat, contact your doctor as soon as possible. Your doctor will do blood tests regularly to monitor the levels of these electrolytes in your blood while you are taking Jardiance (Empagliflozin).

Glucose control: When Jardiance (Empagliflozin) is taken along with other medications for diabetes, glucose levels may drop too far, causing confusion, cold sweats, cool and pale skin, headache, fast heartbeat, or weakness. Your doctor may suggest decreasing the dose of your other medications when you first start taking Jardiance (Empagliflozin). If you take other medications for diabetes, discuss with your doctor how Jardiance (Empagliflozin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Jardiance (Empagliflozin), and whether any special monitoring is needed.

Kidney function: Jardiance (Empagliflozin) may cause a decrease in kidney function. If you have reduced kidney function or kidney disease, discuss with your doctor how Jardiance (Empagliflozin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Jardiance (Empagliflozin), and whether any special monitoring is needed.

Low blood pressure: Jardiance (Empagliflozin) causes an increased amount of fluid to be removed from the body through the urine. As a result, it can cause decreases in blood pressure that may cause dizziness, especially when rising from a sitting or lying position. To reduce the possibility of dizziness or fainting, rise slowly from sitting or lying down.

Surgery: Jardiance (Empagliflozin) should be stopped temporarily for surgery (except for minor surgery where food and fluid intake is not restricted). You will be restarted on Jardiance (Empagliflozin) after surgery once you are eating and drinking again and your kidney function has been tested and is normal. Talk to your doctor for specific instructions.

Urinary tract infection: Jardiance (Empagliflozin) increases the risk of developing Urinary Tract Infections. If you experience symptoms of a urinary tract infection, such as increased need to urinate, burning sensation when urinating, cloudy urine, strong-smelling urine, or pelvic pain, contact your doctor.

Yeast infections: There is an increased risk of developing genital or vaginal yeast infections when taking Jardiance (Empagliflozin), as a result of increased glucose in the urine. This is more likely to occur for uncircumcised men and for people who have a history of yeast infections.

Pregnancy: Jardiance (Empagliflozin) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Jardiance (Empagliflozin), contact your doctor immediately.

Breast-feeding: It is not known if Jardiance (Empagliflozin) passes into breast milk. If you are a breast-feeding mother and are taking Jardiance (Empagliflozin), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Jardiance (Empagliflozin) have not been established for children.

Seniors: Seniors are at an increased risk of experiencing urinary tract infections and decreases in blood pressure while taking Jardiance (Empagliflozin).

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Synjardy.

Alcohol consumption: Anyone taking metformin should avoid excessive alcohol intake.

Cholesterol: Empagliflozin may causes increases to cholesterol levels. If you have increased cholesterol, discuss with your doctor how Synjardy may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Synjardy, and whether any special monitoring is needed.

Dehydration: Empagliflozin - metformin may cause a decrease in the amount of fluid in your body. This dehydration has effects throughout the body. Dehydration can cause decreased kidney function, which in turn reduces the effectiveness of Synjardy. It can cause decreased blood pressure, which may cause dizziness or fainting. Severely decreased blood pressure also contributes to heart problems. Certain other medications, such as diuretics (water pills), can cause dehydration. If you experience symptoms of dehydration, such as thirst, decreased urine or tear production, dizziness, or Headaches, contact your doctor.

Diabetic ketoacidosis (DKA): Empagliflozin has been associated with DKA. This is a potentially life-threatening condition caused by not enough insulin in the blood to use the glucose in the bloodstream. When this happens, the body starts to burn ketones for fuel and can make the blood acidic. This condition is more likely to develop if you are following a very low carbohydrate diet, are dehydrated, or have consumed a large amount of alcohol. Symptoms of DKA include difficulty breathing, nausea, vomiting, abdominal pain, confusion, loss of appetite, excessive thirst, and unusual fatigue or sleepiness. If you experience these symptoms, get immediate medical help.

Dizziness: Some people taking empagliflozin may experience decreases in blood pressure. This occurs because the medication causes an increased amount of fluid, along with the glucose, to be removed from the body through the kidneys. These blood pressure drops could lead to dizziness, lightheadedness, and falls. This may occur when you shift your body position, such as rising from a sitting or lying position. If you experience this problem, try getting up more slowly. If it persists or if you faint, contact your doctor. Seniors and other individuals who are at risk of experiencing low blood pressure (e.g., dehydration, taking medications for high blood pressure) should discuss with their doctor how Synjardy may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Synjardy, and whether any special monitoring is needed.

Dizziness/reduced alertness: Empagliflozin - metformin may cause low blood sugar, which may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how Synjardy affects you.

Dye or contrast agents: If you are going to have an X-ray procedure that uses dye or a contrast agent, you may need to stop taking Synjardy for a short time. Contact your doctor for instructions.

Glucose control: When empagliflozin is taken along with other medications for diabetes, glucose levels may drop too far, causing confusion, cold sweats, cool and pale skin, headache, fast heartbeat, or weakness. If you are using insulin, your doctor may suggest decreasing the dose of the insulin when you first start taking empagliflozin - metformin. If you take other medications for diabetes, discuss with your doctor how Synjardy may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Synjardy, and whether any special monitoring is needed.

Kidney function: The effectiveness of empagliflozin depends on kidney function because it increases the amount of glucose eliminated through the kidneys. Over time, Synjardy may cause kidney problems. If you experience signs of kidney problems, such as puffy hands, face, or feet, high blood pressure, unusual muscle cramping, or darkened urine, Synjardy may be affecting how well your kidneys are working. If you notice any of these symptoms, contact your doctor as soon as possible.

Decreased kidney function or Kidney Disease can cause metformin to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Synjardy may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Synjardy, and whether any special monitoring is needed.

Lactic acidosis: Lactic acidosis is a rare but serious problem that occurs due to metformin accumulation (i.e., the body doesn't get rid of it fast enough) during treatment. If you have severe kidney disease you are at higher risk of developing lactic acidosis. People with Congestive Heart Failure are also at an increased risk of lactic acidosis. Since alcohol may increase the risk of lactic acidosis, do not drink a lot of alcohol over the short or long term while taking Synjardy. When it does occur (very rarely), it is fatal in 50% of cases. If you experience symptoms of lactic acidosis (e.g., weakness, tiredness, drowsiness, unusual muscle pain, trouble breathing, feeling cold, dizziness, light-headedness, slow or irregular heartbeat, or stomach pain with nausea, vomiting, or diarrhea), stop taking Synjardy and get immediate medical attention.

Liver function: Decreased liver function has been linked to lactic acidosis. Synjardy is not recommended for people with severely reduced liver function. If you have moderately reduced liver function, discuss with your doctor how Synjardy may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Synjardy, and whether any special monitoring is needed.

Reduced response: Over a period of time, you may become progressively less responsive to a particular treatment for diabetes because your diabetes worsens. If empagliflozin - metformin fails to lower blood sugar to target levels, talk to your doctor. Your doctor may want to stop metformin or recommend another medication.

Surgery: Synjardy should be stopped temporarily for surgery (except for minor surgery where food and fluid intake is not restricted). You will be restarted on Synjardy once you are eating and drinking and your kidney function has been tested and is normal. Talk to your doctor for specific instructions.

Vitamin B12 levels: Metformin may decrease vitamin B12 levels. Your doctor will monitor your B12 levels with blood tests while you are taking Synjardy.

Yeast infections: There is an increased risk of developing genital yeast infections when taking empagliflozin as a result of increased glucose in the urine. This is more likely to occur for uncircumcised males and for people who have a history of yeast infections.

Pregnancy: Synjardy should not be used during pregnancy. If you become pregnant while taking Synjardy, contact your doctor immediately.

Breast-feeding: It is not known if empagliflozin passes into breast milk. Metformin passes into breast milk. If you are a breast-feeding mother and are taking Synjardy, it may affect your baby. Breast-feeding is not recommended when you are taking Synjardy.

Children: The safety and effectiveness of Synjardy have not been established for children less than 18 years of age.

Seniors: Seniors are at an increased risk of experiencing side effects with Synjardy. Your doctor may suggest lower doses of Synjardy to reduce this risk.