Empagliflozin

WHY is this medicine prescribed?

Empagliflozin is used along with diet and exercise, and sometimes with other medications, to lower blood sugar levels in adults and children 10 years of age and older with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally). Empagliflozin is also used to reduce the risk of stroke, heart attack, or death in people who have type 2 diabetes along with heart and blood vessel disease. Empagliflozin is also used in adults with heart failure to reduce the risk of needing to be hospitalized and death due to heart and blood vessel disease. It is also used to reduce the risk of worsening kidney disease, the need to be hospitalized, and the risk of death due to heart disease in adults with kidney disease. Empagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to get rid of more glucose in the urine. Empagliflozin is not used to treat type 1 diabetes (condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated).

Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Taking empagliflozin, making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Empagliflozin comes as a tablet to take by mouth. It is usually taken once a day in the morning with or without food. Take empagliflozin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take empagliflozin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of empagliflozin and increase your dose as needed.

Empagliflozin helps to control your condition, but does not cure it. Continue to take empagliflozin even if you feel well. Do not stop taking empagliflozin without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking empagliflozin,

• tell your doctor and pharmacist if you are allergic to empagliflozin, any other medications, or any of the ingredients in empagliflozin tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you regularly drink alcohol or sometimes drink large amounts of alcohol in a short time (binge drinking), have ever had an amputation, are on a low sodium diet, or if you have an infection. Also, tell your doctor if you have or have ever had urinary tract infections or problems with urination, low blood pressure, high cholesterol, pancreatic disease including pancreatitis (swelling of the pancreas) or have had surgery on your pancreas, yeast infections in the genital area, peripheral vascular disease (narrowing of blood vessels in feet, legs, or arms causing numbness, pain, or coldness in that part of the body), neuropathy (nerve damage that causes tingling, numbness, and pain, usually in your hands and feet), foot ulcers or sores, or kidney or liver disease. If you are male, tell your doctor if you have never been circumcised. Tell your doctor if you are eating or drinking less due to illness, surgery, or a change in your diet; if you are following a ketogenic diet (a high fat, low carbohydrate diet); or if you have recently had diarrhea, vomiting, been in the sun too long, or have been sweating a lot, which may cause dehydration (loss of a large amount of body fluids).

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Do not breastfeed while you are taking empagliflozin. If you become pregnant while taking empagliflozin, call your doctor.

• you should know that empagliflozin may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. If you have this problem, call your doctor. This problem is more common when you first start taking empagliflozin. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

• alcohol may cause a change in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are taking empagliflozin.

• ask your doctor what to do if you get sick, develop an infection or fever, experience unusual stress, or are injured. These conditions can affect your blood sugar and the amount of empagliflozin you may need.

What SPECIAL DIETARY instructions should I follow?

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthful diet and exercise regularly. Follow your doctor's instructions about drinking enough fluids throughout the day while you are on this medication.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

Empagliflozin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• urinating a lot, including at night
• increased thirst

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• frequent, urgent, burning, or painful urination
• urine that is cloudy, red, pink, or brown
• pelvic or back pain, fever, nausea, or vomiting
• (in women) vaginal odor, white or yellowish vaginal discharge (may be lumpy or look like cottage cheese), or vaginal itching
• (in men) redness, itching, or swelling of the penis; rash on the penis; foul smelling discharge from the penis; or pain in the skin around the penis
• feeling tired, weak, or uncomfortable; along with a fever and pain, tenderness, redness, and swelling of the genitals or the area between the genitals and the rectum

If you experience any of the following symptoms, stop taking empagliflozin and call your doctor immediately or get emergency medical treatment:

• rash
• hives
• itching
• difficulty swallowing or breathing
• swelling of the face, throat, tongue, lips, mouth, or eyes
• hoarseness

If you experience any of the following symptoms of ketoacidosis, stop taking empagliflozin and call your doctor immediately or get emergency medical treatment. If possible, check for ketones in your urine if you have these symptoms, even if your blood sugar is less than 250 mg/dL:

• nausea
• vomiting
• stomach-area pain
• tiredness
• difficulty breathing

You should know that empagliflozin can increase the risk of having a lower limb (toe, foot, or leg) amputation. Your doctor will tell you how to take care of your legs and feet properly to help avoid infections and complications that could lead to an amputation. Follow the doctor's instructions carefully and call your doctor right away if you have any pain, tenderness, sores, ulcers, or swollen, warm, reddened area in your leg or foot, fever or chills, or other signs and symptoms of infection.

Empagliflozin can cause dehydration. It is important that you drink plenty of water while taking empagliflozin. Talk to your doctor or pharmacist about the right amount of water to drink to prevent dehydration while taking empagliflozin.

Empagliflozin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will probably order certain laboratory tests before and during your treatment to check your body's response to empagliflozin.

Your blood sugar levels should be checked regularly to determine your response to empagliflozin. Your doctor will order other lab tests, including glycosylated hemoglobin (HbA1c), to check your response to empagliflozin. Your doctor will also tell you how to check your response to this medication by measuring your blood sugar levels at home. Follow these instructions carefully.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking empagliflozin. Because of the way this medication works, your urine may test positive for glucose.

You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.