Patient Medication Information: uses, side effects, how to take - Jardiance
What is JARDIANCE used for?
JARDIANCE is used:
- along with diet and exercise to improve blood sugar levels in adults with type 2 diabetes. It can be used alone, or with other blood sugar lowering medications.
- to reduce the risk of death due to cardiovascular problems in adults with type 2 diabetes and cardiovascular disease (heart and blood vessel problems).
- along with standard of care, to treat heart failure in adults.
- in adults with chronic kidney disease to reduce the risk of kidney disease progression, or death due to problems with your kidneys, heart or blood vessels.
How does JARDIANCE work?
JARDIANCE belongs to a class of medicines called sodium-glucose co-transporter 2 (SGLT2) inhibitors. If you have too much sugar in your blood, JARDIANCE 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 and kidney benefits. JARDIANCE helps protect your heart from getting weaker and improves your symptoms if you have heart failure. JARDIANCE also helps protect your kidneys from losing their function.
Serious Warnings and Precautions
- Ketoacidosis can happen while you are taking JARDIANCE. It is a serious and life-threatening condition, which may need urgent hospital care. In ketoacidosis the body produces high levels of blood acids called ketones. Some cases of ketoacidosis have led to death. Ketoacidosis can happen to patients with diabetes with normal or high blood sugar levels because the body does not have enough insulin. Cases of ketoacidosis have also been reported in patients without diabetes.
- Seek medical help right away and stop taking JARDIANCE immediately if you have any of the ketoacidosis symptoms. Do this even if your blood sugar levels are normal. The symptoms of ketoacidosis are: difficulty breathing, nausea, vomiting, stomach pain, and loss of appetite. Confusion, feeling thirsty, feeling unusually tired or sleepy, along with a sweet or metallic taste in the mouth or sweet-smelling breath can be noticed. You may have a different odour to your urine or sweat.
Do not use JARDIANCE if you have:
- ketoacidosis or a history of ketoacidosis;
- type 1 diabetes.
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.
JARDIANCE comes in the following dosage forms:
Tablets: 10 mg and 25 mg of empagliflozin.
Do not use JARDIANCE if:
- 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;
- need to have a procedure that requires long periods of fasting;
- have an acute illness;
- have sudden reduction in insulin dose;
- have a history of ketoacidosis.
- are 65 years of age or older and being treated for your blood sugar levels;
- have kidney problems or are on dialysis;
- 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:
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 kidneys are 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.
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.
Monitoring and testing: 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.
The following 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;
- lithium, because JARDIANCE can lower the amount of lithium in your blood.
How to take JARDIANCE:
You should take JARDIANCE:
- once daily;
- at any time of the day;
- by mouth;
with or without food.
Swallow the tablet whole. Do NOT cut or divide tablets.
Your healthcare professional may temporarily stop your JARDIANCE treatment:
- for at least 3 days before, and a period of time after certain types of surgery, or procedures associated with long periods of fasting;
- when you are hospitalized for a serious infection or illness.
If JARDIANCE is stopped, your healthcare professional will:
- continue to monitor for signs or symptoms of ketoacidosis;
- tell you when to start taking JARDIANCE again.
Usual dose:
Patient with Type 2 Diabetes:
- To control your blood sugar: the usual adult starting dose is 10 mg once daily. Your healthcare professional may increase your dose to 25 mg once daily, if needed.
- To reduce the risk of cardiovascular death: the usual adult dose is 10 mg once daily.
Patients with Heart Failure or Chronic Kidney Disease:
The usual adult dose is 10 mg once daily.
Overdose:
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 or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
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 | |||
|---|---|---|---|
| Serious side effects and what to do about them | |||
| Serious side effects and what to do about them | |||
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| 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.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
- Store JARDIANCE tablets at room temperature (15oC to 30oC).
- 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.
If you want more information about JARDIANCE:
- Talk to your healthcare professional.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s, Boehringer Ingelheim (Canada) Ltd., website (https://www.boehringer-ingelheim.ca), or by calling 1-800-263-5103, extension 84633.
The information in this leaflet is current up to the time of the last revision date shown below, but more current information may be available from the manufacturer.