• Jardiance is a brand (trade) name for empagliflozin which may be used in the treatment of type 2 diabetes or to reduce the risk of cardiovascular death in some populations.
• Jardiance (empagliflozin) works by blocking the sodium-glucose co-transporter 2 (SGLT2) which is a protein located in the early proximal tubule of a nephron (a kidney cell), which is responsible for the reabsorption of glucose from the blood that flows through the kidneys (the glomerular filtrate) back into circulation. By blocking this transporter, empagliflozin prevents glucose from being reabsorbed and increases how much glucose is excreted in the urine.
• Jardiance belongs to the class of medicines called SGLT-2 inhibitors.

• Jardiance may be used in the treatment of type 2 diabetes in adults and children aged 10 and older alongside diet modification and increased exercise.
• Jardiance may also be given to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. or to reduce cardiovascular death in adults with type 2 diabetes and cardiovascular disease.
• Jardiance is effective at reducing blood glucose levels, HbA1c, and it also reduces body weight.
• Jardiance may be given in addition to other medications for diabetes, such as insulin, metformin, or sulfonylureas.
• A dosage adjustment is not needed for people taking Jardiance who have liver disease.
• Jardiance is taken orally.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Common side effects of Jardiance include low blood sugar levels, an increased risk of infections (urinary, genital, and upper respiratory tract), high cholesterol levels, increased urination, joint pain, and nausea.
• Jardiance is not suitable for people with type 1 diabetes or to treat diabetic ketoacidosis.
• Any dehydration or volume depletion should be corrected before starting Jardiance.
• Jardiance is not suitable for people with moderate kidney disease with an eGFR of less than 45 mL/min/1.73m2. If Jardiance is started and then a patient's eGFR drops to less than 45 mL/min/1.73m2 then Jardiance should be discontinued. No dosage adjustment is necessary if a patient's eGFR is greater than 45 mL/min/1.73m2. People more at risk of acute kidney injury with Jardiance include those who are dehydrated, taking certain medications, such as NSAIDs, ACE inhibitors, ARBs, or diuretics, or in those with a reduced calorie intake.
• Jardiance may cause low blood pressure. Those with volume depletion, seniors, with kidney disease or who are also taking diuretics are more at risk.
• Jardiance has been associated with an increased risk of diabetic ketoacidosis (caused by a severe lack of insulin), that may be life-threatening. This may be associated with severe metabolic acidosis. If this occurs, prompt treatment for ketoacidosis should be initiated and Jardiance discontinued. Those with pancreatic insulin deficiency, on a calorie-restricted diet, or with an excessive alcohol intake are more at risk.
• Treatment with Jardiance increases the risk of urinary tract infections, genital fungal infections, and a rare necrotizing infection called necrotizing fasciitis of the perineum (Fournier's gangrene), which causes pain, tenderness, redness, and swelling in the genital area.
• LDL cholesterol levels may increase with Jardiance treatment.
• Jardiance is not recommended during the second and third trimester of pregnancy and there is a lack of data assessing the risk for the first trimester of pregnancy. However, the risk of Jardiance use in the first trimester should be weighed up against the risk of uncontrolled diabetes on the fetus with regards to birth defects and miscarriage.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Jardiance is usually taken once daily in the morning, either with or without food. Your doctor will start you on 10mg and may increase the dose to 25mg if you are tolerating Jardiance well.
• Take Jardiance exactly as prescribed. If you miss a dose, take it as soon as you remember but not if it is within eight hours of your next dose, just go back to your regular dosing schedule.
• Jardiance should be taken in addition to any other medications prescribed by your doctor. You should also adhere to any dietary recommendations and undertake regular physical activity. See your doctor if you develop any kind of infection, are scheduled for surgery, or are dealing with a lot of stress as your medications requirements may change.
• Jardiance may cause your blood pressure to drop. This is more likely when you first start taking Jardiance, in seniors, in people already with low blood pressure, in those taking a low sodium diet, and in those taking diuretics. This may make you feel dizzy or faint. Talk to your doctor if this happens.
• Tell your doctor immediately if you develop signs or symptoms of diabetic ketoacidosis which may include excessive thirst, frequent urination, abdominal pain, fruity breath, or severe metabolic acidosis which may include nausea and vomiting, shortness of breath, or fatigue. Educate your friends and family about the signs of diabetic ketoacidosis and metabolic acidosis to watch out for.
• Jardiance has been associated with an increased risk of urinary tract infections. If you develop symptoms such as burning or pain when urinating, an increased frequency of urination, fever, back or pelvic pain, see your doctor.
• Jardiance may also increase your risk of genital infections. Symptoms of a vaginal yeast infection include a white or yellowish vaginal discharge, vaginal itching, or vaginal odor. Symptoms of a yeast infection of the penis include redness, itching, or swelling of the penis, a foul-smelling discharge, and penile pain.
• If you are intending to become pregnant while taking Jardiance, talk to your doctor before you conceive.

• Urinary glucose excretion increases almost immediately following a dose of Jardiance and is maintained with daily dosing averaging approximately 64 grams per day with 10mg Jardiance and 78 grams per day with 25mg Jardiance. It takes about three days for the effects of one dose of Jardiance to wear off.
• Urine volume also increases after a dose of Jardiance but drops again with continued dosing. On day 1 the average increase in urine volume from baseline was 341mL on Day 1 and 135mL on Day 5 with Jardiance 25mg once daily.
• After 24 weeks, 35% of patients taking Jardiance 10mg achieved an HbA1c of less than 7% and 44% of patients taking Jardiance 25mg achieved an HbA1c of less than 7%, compared to only 12% of patients assigned placebo (a pretend pill).
• Significant changes in baseline fasting plasma glucose values were also reported: -19 in patients taking Jardiance 10mg and -25 in those taking Jardiance 25mg compared to +12 in those taking placebo.
• After 24 weeks patients taking Jardiance 10mg lost an average of 2.8kg and those taking Jardiance 25mg lost an average of 3.2kg.

Medicines that interact with Jardiance may either decrease its effect, affect how long it works for, increase side effects, or have less of an effect when taken with Jardiance. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Jardiance include:

• acetazolamide
• anticonvulsants such as phenytoin
• antipsychotics, such as aripiprazole or clozapine
• beta-blockers, such as atenolol, labetalol, and metoprolol, may enhance the hypoglycemic effects
• ciprofloxacin or gatifloxacin
• corticosteroids, such as prednisone or cortisone
• diuretics, such as bumetanide, HCTZ, and bendroflumethiazide, which may enhance the potential for volume depletion
• HIV medications, such as amprenavir, atazanavir, and fosamprenavir
• hormones, such as ethinylestradiol and hydroxyprogesterone
• insulin (may increase risk of hypoglycemia)
• isoniazid
• other medications that affect blood sugar levels or are used for diabetes, such as glimepiride, or metformin.

Jardiance may also enhance the toxic effects of alcohol, causing flushing.

Urine glucose tests should not be used to monitor glucose control in people receiving SGLT2 inhibitors such as Jardiance as these increase urinary glucose excretion and will lead to positive urine glucose tests. Alternative methods to monitor glucose control should be used. Interference with 1,5-AG assays may also occur.

Note that this list is not all-inclusive and includes only common medications that may interact with Jardiance. You should refer to the prescribing information for Jardiance for a complete list of interactions.