Jardiance

Do not give Jardiance (Empagliflozin) to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take Jardiance (Empagliflozin) if their doctor has not prescribed it.

How should I use Jardiance (Empagliflozin)?

The usual starting dose of Jardiance (Empagliflozin) is 10 mg taken by mouth once a day. Depending on how effectively it reduces your blood glucose, your doctor may increase the dose to 25 mg taken once a day.

Jardiance (Empagliflozin) may be taken at any time of the day, with or without food. The tablet must be swallowed whole. Do not cut or chew the tablets.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Jardiance (Empagliflozin) exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is less than 12 hours until your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Jardiance (Empagliflozin) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause unusual tiredness; it could make you more prone to urinary tract infections and infections of the genital organs; it may make you urinate more frequently; it may cause low blood sugar levels, which could make you feel dizzy, shaky or weak; it may lower your blood pressure, which could cause weakness and/or dizziness; occasionally, it may cause weight loss. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

10 mg
Each pale yellow, round, biconvex and bevelled-edged, film-coated tablet, debossed with "S10" on one side and the Boehringer Ingelheim company symbol on the other side, contains 10 mg of Jardiance (Empagliflozin). Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, macrogol, microcrystalline cellulose, titanium dioxide, talc, and yellow ferric oxide.

25 mg
Each pale yellow, oval, biconvex, film-coated tablet, debossed with "S25" on one side and the Boehringer Ingelheim company symbol on the other side, contains 25 mg of Jardiance (Empagliflozin). Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, macrogol, microcrystalline cellulose, titanium dioxide, talc, and yellow ferric oxide.

Do not take Jardiance (Empagliflozin) if you:

• are allergic to Jardiance (Empagliflozin) or any ingredients of the medication
• have severely decreased kidney function or end-stage Kidney Disease, or are on dialysis
• have type I diabetes

There may be an interaction between Jardiance (Empagliflozin) and any of the following:

• acetylsalicylic acid (Asa)
• androgens (e.g., testosterone)
• angiotensin converting enzyme inhibitors (ACEIs; Captopril, Enalapril, Ramipril)
• atypical antipsychotics (e.g., Clozapine, Olanzapine, Quetiapine, Risperidone)
• other diabetes medications (e.g., chlorpropamide, glipizide, Glyburide, insulin, Metformin, Rosiglitazone)
• Disopyramide
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• Duloxetine
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Everolimus
• Glucagon
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
• Lanreotide
• levodopa
• mifepristone
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• Niacin
• Octreotide
• oral corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Pasireotide
• pentamidine
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• somatostatin
• sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
• Tacrolimus
• Teriflunomide
• Vorinostat

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Jardiance (Empagliflozin). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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).

This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. Like all individuals with diabetes, you should monitor your blood sugar levels regularly using the appropriate device. If you remember missing a dose within 12 hours of the time it is usually taken, take it as soon as you remember, then take the next dose at the regularly scheduled time. If the dose is missed by more than 12 hours, skip the missed dose. Do not double the next dose to catch up. This medication may be taken with or without food.