Jardiance (Empagliflozin): What is it used for, How does it work, What are the side effects?
What is JARDIANCE used for?
- JARDIANCE (Empagliflozin) is used along with diet and exercise to:
- improve blood sugar levels in adults with type 2 diabetes. JARDIANCE can be used:
- alone, if you cannot take metformin;
- with metformin;
- with metformin and a sulfonylurea;
- with pioglitazone (with or without metformin);
- with linagliptin and metformin; or
- with basal or prandial insulin (with or without metformin).
- reduce the risk of cardiovascular death in adults:
- with type 2 diabetes and cardiovascular disease (heart and blood vessel problems).
- improve blood sugar levels in adults with type 2 diabetes. JARDIANCE can be used:
- JARDIANCE is also used in adults along with standard of care to treat long-lasting (chronic) heart failure:
- when the heart is weak and cannot pump enough blood to your body; or
- when the heart is unable to properly relax and fill with blood and cannot pump enough blood to your body.
How does JARDIANCE work?
JARDIANCE belongs to a class of medicines called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It removes excess sugar from the body through the urine. This reduces the amount of sugar in the blood. JARDIANCE can also affect other organs and functions in your body (e.g., blood vessels, the heart and kidneys) to provide cardiovascular benefits.
What are the ingredients in JARDIANCE?
Medicinal ingredient: Empagliflozin.
Non-medicinal ingredients: Colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, macrogol, microcrystalline cellulose, titanium dioxide, talc, and yellow ferric oxide.
What strength is JARDIANCE tablets available in?
Tablets: 10 mg and 25 mg of empagliflozin.
Who should not use Jardiance?
- you have severe kidney problems, or you are on dialysis;
- you are allergic to empagliflozin or any of the other ingredients in JARDIANCE.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take JARDIANCE. Talk about any health conditions or problems you may have, including if you:
- have type 1 diabetes (your body does not produce any insulin). JARDIANCE should not be used if you have type 1 diabetes;
- have ketoacidosis or a history of ketoacidosis (increased level of ketones in the blood). JARDIANCE should not be used in patients with ketoacidosis;
- have an increased chance of developing ketoacidosis, including if you:
- are dehydrated or suffer from excessive vomiting, diarrhea, or sweating;
- are on a very low carbohydrate diet;
- have been fasting for a while;
- are eating less, or there is a change in your diet;
- drink a lot of alcohol;
- have or have had problems with your pancreas. This includes pancreatitis (inflammation of the pancreas) or surgery on your pancreas;
- are going to have surgery and after your surgery;
- are hospitalized for a major surgery, serious infection, or serious medical illnesses;
- have an acute illness;
- have sudden reduction in insulin dose;
- have a history of diabetic ketoacidosis (DKA).
- are 65 years of age or older and being treated for your blood sugar levels. JARDIANCE is not recommended to improve blood sugar levels if you are 85 years or older;
- have kidney problems;
- have liver problems;
- have low blood pressure;
- are taking a medicine for high blood pressure or taking a water pill (used to remove excess water from the body);
- are taking medicines to lower your blood sugar such as glyburide, gliclazide, glimepiride (sulfonylureas), or insulin. Taking JARDIANCE with any of these medicines can increase the risk of having low blood sugar (hypoglycemia);
- have intolerance to some milk sugars. JARDIANCE tablets contain the milk sugar lactose;
- have a history of infections in the genital area;
- have a history of urinary tract infections.
Other warnings you should know about Jardiance?
Taking JARDIANCE can cause the following:
- Increased urination: This is common in patients with high blood sugar (glucose).
- Urinary tract infections: This can include urosepsis and pyelonephritis. Your healthcare professional will monitor your health for any signs of an infection. If a urinary tract infection is suspected, they may temporarily stop your treatment with JARDIANCE.
- Yeast infections of the penis or vagina: This is more likely if you have had a yeast infection in the past.
- Fournier’s gangrene: This is a rare, but serious and potentially life-threatening infection affecting the soft tissue around the groin that may lead to hospitalization, surgery, and even death in both men and women. If you notice any signs of Fournier’s gangrene, stop taking JARDIANCE and tell your healthcare professional right away.
- Serious allergic reactions: The signs can include swelling of tissue under the skin, rashes, and itchiness. If you notice any signs of an allergic reaction, stop taking JARDIANCE and tell your healthcare professional right away.
- Kidney problems: This may happen shortly after you start taking JARDIANCE. This can affect how your kidney is working. Your healthcare professional will assess your kidney function before and during your treatment.
See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
Can you use JARDIANCE while pregnant or breastfeeding?
Pregnancy: JARDIANCE should not be used if you are pregnant or planning to become pregnant. It is not known if JARDIANCE can harm your unborn baby. Talk with your healthcare professional about the best way to control your blood sugar while you are pregnant. If you become pregnant while taking JARDIANCE, stop your treatment and tell your healthcare professional.
Breastfeeding: JARDIANCE should not be used if you are breastfeeding. It is not known if JARDIANCE will pass into your breastmilk. Talk to your healthcare professional if you are planning to breastfeed.
What testing and monitoring is recommended while taking JARDIANCE?
Your healthcare professional will monitor your health before and during your treatment with JARDIANCE. This can include performing physical examinations and blood tests. This will help them to evaluate:
- your blood glucose levels;
- your hemoglobin (a protein in red blood cells that carries oxygen) levels;
- your kidneys, especially if you are prescribed another medication;
- your fluid volume, especially if you are at a higher risk of volume depletion or have a condition that may lead to fluid loss (e.g., gastrointestinal problems). If fluid loss is detected your healthcare professional may stop your treatment until this is resolved;
- the amount of red blood cells in your blood (hematocrit).
JARDIANCE will cause your urine to test positive for sugar (glucose).
Driving and using machines: JARDIANCE can cause dizziness and light-headedness. Before you drive or do tasks that require special attention, wait until you know how you respond to JARDIANCE.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
What medications may interact with JARDIANCE?
- medicines used for diabetes, especially sulfonylurea medications such as glyburide, gliclazide, glimepiride (sulfonylureas), or insulin;
- medicines used to increase the amount of water released in your urine known as diuretics.
How to take JARDIANCE?
You should take JARDIANCE:
- once a day;
- at any time of the day;
- with or without food.
Swallow the tablet whole. Do NOT cut or divide tablets.
What is the usual dose of JARDIANCE?
Patient with Type 2 Diabetes:
- To control your blood sugar: the usual adult starting dose is 10 mg once a day. Your healthcare professional may increase your dose to 25 mg once a day, if needed.
- To reduce the risk of cardiovascular death: the usual adult dose is 10 mg once a day.
Patients with Heart Failure:
The usual adult dose is 10 mg once a day.
What to do if you overdose on Jardiance?
If you think you, or a person you are caring for, have taken too much JARDIANCE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
What to do if you miss a dose of Jardiance?
If you miss a dose of this medication, follow the instructions below to ensure that you do not take a double dose of JARDIANCE:
- If it is 12 hours or more until your next dose, take the missed dose as soon as you remember. Then take your next dose at the usual time.
- If it is less than 12 hours until your next dose, skip the missed dose. Then take your next dose at the usual time.
What are possible side effects from using JARDIANCE?
These are not all the possible side effects you may have when taking JARDIANCE. If you experience any side effects not listed here, tell your healthcare professional.
Side effects of JARDIANCE may include:
- unusual thirst;
- passing more urine than usual or needing to pass more often;
- itching;
- rash or hives;
- straining or pain when emptying the bladder;
- constipation;
- weight decrease.
Serious side effects and what to do about them | |||
|---|---|---|---|
Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
Only if severe | In all cases | ||
VERY COMMON | |||
Hypoglycemia (low blood sugar): shaking, sweating, rapid heartbeat, change in vision, hunger, headache and change in mood. | √ | ||
COMMON | |||
Urinary tract infection (infection in the urinary system including kidneys, ureters, bladder and urethra): pain or burning sensation when urinating, pain in the pelvis, mid-back pain, increased need to urinate, blood in urine, strong smelling urine, or cloudy urine. | √ | ||
Vaginal yeast infection (a genital infection): severe itching, burning, soreness, irritation, or a whitish-gray cottage cheese-like discharge. | √ | ||
Yeast infection of the penis (a genital infection): red, swollen, itchy head of penis, thick, lumpy discharge under foreskin, unpleasant odour, difficulty retracting foreskin, or pain passing urine or during sex. | √ | ||
Volume depletion (loss of fluids from the body, dehydration): dry or sticky mouth, headache, dizziness, shock, low blood pressure, thirsty, or urinating less often than normal. | √ | ||
Allergic skin reactions: rash, hives, or swelling of your lips, face, throat, or tongue that may cause difficulty in breathing or swallowing. | √ | ||
UNCOMMON | |||
Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, or fatigue (may occur when you go from lying to sitting to standing up). | √ | ||
Kidney problems: any change in the amount, frequency or colour (pale or dark) of urine, nausea, vomiting, fever, swelling of extremities, fatigue, thirst, dry skin, irritability, dark urine, blood in the urine, rash, weight gain (from retaining fluid), loss of appetite, abnormal blood test results, or mental status changes (drowsiness, confusion, coma). | √ | ||
Urosepsis (severe infection of the blood that spreads from urinary tract throughout body): fever, high or very low body temperature, chills, rapid breathing, rapid heartbeat, pain with urination, difficulty urinating, little to no urine, dizziness, low blood pressure or palpitations. | √ | ||
Acute kidney infection: painful, urgent or frequent urination, lower back (flank) pain, fever or chills, cloudy or foul-smelling urine or sweat, blood in your urine, difficulty breathing, nausea, vomiting, stomach pain, loss of appetite, confusion, thirst, unusual fatigue, sleepiness or tiredness, a sweet or metallic taste in the mouth, or sweet smelling breath. | √ | ||
RARE | |||
Ketoacidosis (high levels of ketones, a type of acid, in urine or blood): rapid weight loss, feeling sick or being sick, difficulty breathing or fast and deep breathing, feeling very thirsty, vomiting, stomach pain, nausea, loss of appetite, confusion, fatigue, feeling unusually tired or sleepy, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat. | √ | ||
UNKNOWN FREQUENCY | |||
Fournier’s gangrene (a serious infection affecting soft tissue): fever, feeling weak, tiredness, uncomfortable tenderness, redness, or swelling in and around the genitals or anus. | √ | ||
Pancreatitis (inflammation of the pancreas): upper abdominal pain, severe stomach pain that lasts and gets worse when you lie down; nausea, vomiting, fever, rapid heartbeat, or tenderness when touching the abdomen. | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
How to store Jardiance?
- Store JARDIANCE tablets at room temperature (15°C to 30°C).
- If there are any leftover, unused or expired tablets, bring them to your local pharmacist for proper disposal. Do not flush the medication down the toilet or sink.
- Keep out of reach and sight of children.
Disclaimer: We have made every effort to ensure that all information is factually correct and up to date, however this article is not comprehensive and does not contain all relevant information about the topic. IT should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should consult your doctor or pharmacist before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.