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)..
HEALTH CANADA ADVISORY
May 16, 2016
Health Canada has issued new information concerning the use of Jardiance (Jardiance (Empagliflozin)). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
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).