Empagliflozin Metformin HCI (Jardiance Duo®) Prescribing Information

Empagliflozin (Jardiance®) is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes, and also to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.

Empagliflozin (Jardiance®) is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
 

Important safety information

What is the most important information I should know about Empagliflozin (Jardiance®)?

Empagliflozin (Jardiance®) can cause serious side effects, including:

• Dehydration. Empagliflozin (Jardiance®) can cause some people to have dehydration (the loss of body water and salt). Dehydration may cause patients to feel dizzy,  faint, light-headed, or weak, especially when they stand up. There may be a higher risk of dehydration if the patient: has low blood pressure, take medicines to lower  their blood pressure, including water pills (diuretics), are on a low salt diet, have kidney problems, are 65 years of age or older. 

• Ketoacidosis (increased ketones in the blood or urine). Ketoacidosis is a serious condition and may need to be treated in the hospital. Ketoacidosis may lead to death.  Ketoacidosis occurs in people with type 1 diabetes and can also occur in people with type 2 diabetes taking Empagliflozin (Jardiance®), even if blood sugar is less  than 250 mg/dL. Advise your patient to stop taking Empagliflozin (Jardiance®) if they present any of the following symptoms, and if possible, check for ketones in  their urine: nausea, vomiting, stomach-area (abdominal) pain, tiredness, or trouble breathing.

• Serious urinary tract infections. Serious urinary tract infections can occur in people taking Empagliflozin (Jardiance®) and may lead to hospitalization. Symptoms of  a urinary tract infection usually include a burning feeling when passing urine, a need to urinate often or right away, pain in the lower part of your stomach or pelvis,  or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting.

• Vaginal yeast infection. Women who take Empagliflozin (Jardiance®) may get vaginal yeast infections. Symptoms may include vaginal odor, white or yellowish  vaginal discharge (discharge may be lumpy or look like cottage cheese), and/or vaginal itching.

• Yeast infection of the penis. Men who take Empagliflozin (Jardiance®) may get a yeast infection of the skin around the penis, especially uncircumcised males and  those with chronic infections. Symptoms may include redness, itching or swelling of the penis, rash of the penis, foul smelling discharge from the penis, and /or pain  in the skin around the penis.