Uses

Empagliflozin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Empagliflozin is also used in patients with type 2 diabetes and heart disease to lower the risk of death from heart attack or stroke. Empagliflozin works by increasing the removal of sugar by your kidneys.

Empagliflozin is also used to treat heart failure and kidney disease. It helps to lower the risk of death from heart disease and reduces the need of going to a hospital to treat heart failure or kidney disease. It also helps to lower the risk of dialysis in people with kidney disease. Empagliflozin works by increasing the removal of sodium by your kidneys.

How To Use

Read the Medication Guide provided by your pharmacist before you start taking empagliflozin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. The dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Tell your doctor if your condition does not improve or if it worsens.

Side Effects

Frequent urination, dizziness, or lightheadedness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of a urinary tract infection (such as burning/painful/frequent/urgent urination, pink/bloody urine)
• signs of kidney problems (such as change in the amount of urine)

Get medical help right away if you have any very serious side effects, including:

• unusual tiredness
• nausea/vomiting
• stomach/abdominal pain
• trouble breathing

This medication may cause a new yeast infection in the vagina or the penis. It may also cause a rare but very serious bacterial infection in the genital/anal area (Fournier's gangrene) in people with type 2 diabetes. Tell your doctor right away if you have signs of a yeast infection in the vagina (such as unusual vaginal discharge/burning/itching/odor) or in the penis (such as redness/itching/swelling of the penis, unusual discharge from the penis). However, get medical help right away if you have any pain/redness/swelling in or around the genital/anal area, along with a fever or feeling unwell.

This medication may increase the risk of lower limb amputation (especially of the toe and foot). The risk is higher if you have poor blood flow in the legs, nerve problems, foot ulcers, or have had a previous amputation. To lessen the risk, check your feet regularly and tell your doctor if you have new pain, tenderness, sores, or ulcers on your legs or feet.

This medication may cause you to become dehydrated. This can lead to serious kidney damage. Drink plenty of fluids to prevent dehydration. Tell your doctor or pharmacist right away if you are not able to drink fluids as usual, or losing fluid (such as due to vomiting, diarrhea, or heavy sweating). Also, tell your doctor right away if you have any signs of dehydration, such as urinating less than usual, unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness/fainting.

If you are taking empagliflozin for diabetes, empagliflozin does not usually cause low blood sugar (hypoglycemia). Low blood sugar may occur if this drug is prescribed with other diabetes medications, or if you do not consume enough calories from food, or if you do unusually heavy exercise. Talk with your doctor or pharmacist about whether the dose of your other diabetes medication needs to be lowered. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include increased thirst/urination. If these symptoms occur, tell your doctor right away. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking empagliflozin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney problems (such as kidney dialysis)
• liver problems
• disease of the pancreas (pancreatitis)
• dehydration
• use/abuse of alcohol
• low blood pressure
• high cholesterol
• history of yeast infections in the vagina or penis
• blocked or narrowed blood vessels, usually in the leg
• nerve problems (such as diabetic peripheral neuropathy)
• foot sores or ulcers
• amputation

If you have diabetes, you may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcohol while taking this medication because it can increase your risk of developing low blood sugar and a high ketone level.

If you have diabetes, it may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Also, if you are eating less or not able to eat due to these conditions or any illness, this can lead to a high ketone level while you are taking this medication. Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar or ketone testing.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be at greater risk for low blood sugar while using this drug.

Older adults may be more sensitive to the side effects of this drug, especially dehydration, kidney problems, and dizziness/fainting (usually when standing).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin).

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are unaffected by these drugs.

Many drugs can affect blood sugar, making it harder to control in people with diabetes. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar if you have diabetes. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This medication may interfere with certain lab tests (such as urine glucose test), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as kidney function, blood pressure, blood sugar, cholesterol, ketones) may be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

If you have diabetes, attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams. Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar regularly as directed.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).