Jardiance - Consumer Medicine Information
|Manufacture:||Boehringer Ingelheim Pharmaceuticals, Inc.|
|Condition:||Diabetes, Type 2|
|Class:||Antidiabetic agents, SGLT-2 inhibitors|
|Ingredients:||empagliflozin, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, macrogol, microcrystalline cellulose, titanium dioxide, talc, and yellow ferric oxide|
About this medication
What the medication is used for
JARDIANCE 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 basal or prandial insulin (with or without metformin).
What it does
JARDIANCE removes excess glucose from the body through the urine.
When it should not be used
Do not take JARDIANCE if you:
- have type 1 diabetes (a disease in which your body does not produce any insulin);
- have diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea, or vomiting);
- have severe kidney problems or you are on dialysis
- have severe liver disease;
- are pregnant or planning to become pregnant; it is not known if JARDIANCE will harm your unborn baby. Talk with your doctor about the best way to control your blood sugar while you are pregnant.
- are breast-feeding or plan to breast-feed; it is not known if JARDIANCE will pass into your breast milk. Talk to your doctor if you would like to breast-feed.
- are allergic to empagliflozin or any of the other ingredients listed below.
What the medicinal ingredient is
What the non-medicinal ingredients are
Colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, macrogol, microcrystalline cellulose, titanium dioxide, talc, and yellow ferric oxide.
What dosage forms it comes in
Tablets 10 mg and 25 mg.
Warnings and Precautions
BEFORE you use JARDIANCE talk to your doctor or pharmacist if you
- are older than 65 years of age;
- have or have had any kidney problems;
- have or have had any cases of liver disease;
- have heart disease or 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 or 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 lactose;
- are 85 years old or older as you should not start taking
- are dehydrated or suffer from excessive vomiting, diarrhea, or sweating;
- are on a very low carbohydrate diet;
- have a history of diabetic ketoacidosis (DKA).
JARDIANCE is not recommended for use in patients under 18 years of age.
JARDIANCE will cause your urine to test positive for sugar (glucose).
JARDIANCE may cause changes in the amount of cholesterol or fats in your blood.
JARDIANCE increases the chance of getting a yeast infection of the penis or vagina. This is more likely in people who have had yeast infections in the past.
Rare cases of diabetic ketoacidosis (DKA) have been reported in patients treated with JARDIANCE. Symptoms of ketoacidosis include difficulty breathing, feeling very thirsty, vomiting, stomach pain, nausea, loss of appetite, confusion, and unusual tiredness. Get immediate medical help if you think you have these symptoms.
Driving and using machines: JARDIANCE may cause dizziness or lightheadedness. Do not drive or use machines until you know how the medicine affects you.
Interactions with this Medication
Talk to your doctor or pharmacist about all the drugs you take. This includes prescription drugs, as well as those you buy yourself, and herbal supplements.
Drugs that may interact with JARDIANCE include: medicines you take for diabetes, especially sulphonylurea medications or insulin. Low blood sugar (hypoglycemia) may occur if you already take another medication to treat diabetes. Discuss with your doctor how much of each medicine to take.
Proper Use of this Medication
Follow the directions given to you by your doctor.
- once a day;
- at any time of the day;
- by mouth;
- with or without food.
Swallow whole. Do NOT cut or divide tablets.
Usual Adult dose
Recommended starting dose: one 10 mg tablet a day.
Your doctor may increase your dose to one 25 mg tablet, if needed to further control your blood sugar level.
|In case of drug overdose, contact a health care practitioner, hospital emergency department, or regional Poison Control Centre immediately, even if there are no symptoms.|
Do not take a double dose of JARDIANCE.
If it is 12 hours or more until your next dose, take JARDIANCE 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.
Side Effects and what to do about them
Side effects may include:
- unusual thirst;
- passing more urine than usual or needing to pass more often;
- straining or pain when empting the bladder.
If any of these affects you severely, tell your doctor or pharmacist.
JARDIANCE can cause abnormal blood test results. Your doctor will decide when to perform blood tests. They may check kidney function, blood fat levels and amount of red blood cells in your blood (hematocrit).
This is not a complete list of side effects. For any unexpected effects while taking JARDIANCE, contact your doctor or pharmacist.
Serious side effects, how often they happen and what to do about them
|Frequency||Symptom / effect||Talk with your doctor or pharmacist||Get immediate medical help|
|Only if severe||In all cases|
|Very Common||Low blood sugar (hypoglycaemia):|
shaking, sweating, rapid heartbeat, change in vision, hunger, headache and change in mood.
|Common||Urinary tract infection: burning sensation when passing urine, pain in the pelvis, or mid-back pain, or increased need to urinate.||✓|
Vaginal yeast infection: severe itching, burning, soreness, irritation, and a whitish-gray cottage cheese-like discharge. Yeast infection of the penis: red, swollen, itchy, head of penis, thick, lumpy discharge under foreskin, unpleasant odour, difficulty retracting foreskin, pain passing urine or during sex.
|Common||Volume depletion (loss of needed fluids from the body, dehydration, especially in patients older than 75 years of age):|
dry or sticky mouth, headache, dizziness or urinating less often than normal.
|Uncommon||Low Blood Pressure:|
dizziness, fainting, lightheadedness. May occur when you go from lying to sitting to standing up.
|Rare||Diabetic Ketoacidosis (DKA):|
difficulty breathing, feeling very thirsty, vomiting, stomach pain, nausea, loss of appetite, confusion, and unusual tiredness.
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
- ways to report:
- Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program Health Canada, Postal Locator 0701E
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).
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.
How to store it
Store at room temperature (15 - 30°C).
Keep in a safe place out of reach from children.
The most current information, the Consumer Information Leaflet
plus the full Product Monograph, prepared for health professionals can be found at: http://www.boehringer-ingelheim.ca or by contacting the sponsor, Boehringer Ingelheim (Canada) Ltd., at: 1-800-263-5103, ext. 84633 (Medical Information).