Canagliflozin is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Canagliflozin is also used to lower the risk of death from heart attack, stroke, or heart failure in adults with type 2 diabetes who also have heart disease.

Canagliflozin is also used to reduce the risk of end-stage kidney disease and hospitalization or death from heart problems in adults who also have kidney problems caused by type 2 diabetes.

Canagliflozin is not for treating type 1 diabetes.

Canagliflozin may also be used for purposes not listed in this medication guide.

You should not use canagliflozin if you have severe kidney disease or if you are on dialysis.

Canagliflozin can cause serious infections in the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or if you don't feel well.

Canagliflozin comes as a tablet to take by mouth. It is usually taken once a day before breakfast or the first main meal of the day. Take canagliflozin 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 canagliflozin 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 canagliflozin and gradually increase your dose.

Canagliflozin controls type 2 diabetes but does not cure it. Continue to take canagliflozin even if you feel well. Do not stop taking canagliflozin without talking to your doctor.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Canagliflozin is usually taken once per day, before the first meal of the day.

You may have very low blood pressure while taking this medicine. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. Drink plenty of liquids while you are taking canagliflozin.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Canagliflozin is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using canagliflozin.

Store at room temperature away from moisture and heat.

You should not use canagliflozin if you are allergic to it, or if you have:

• severe kidney disease (or if you are on dialysis).

Canagliflozin may increase your risk of lower leg amputation, especially if you have had a prior amputation, a foot ulcer, heart disease, circulation problems, or nerve damage.

Tell your doctor if you have ever had:

• heart problems;

• a diabetic foot ulcer or amputation;

• circulation problems or nerve problems in your legs or feet;

• kidney disease;

• liver disease;

• bladder infections or other urination problems;

• a pancreas disorder;

• if you drink often, or drink large amounts of alcohol;

• if you are eating less than usual; or

• if you are on a low salt diet.

Follow your doctor's instructions about using canagliflozin if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester.

You should not use canagliflozin during the second or third trimester of pregnancy.

You should not breastfeed while using this medicine.

Canagliflozin is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

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.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical attention right away if you have signs of a genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well. These symptoms may get worse quickly.

Canagliflozin may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• little or no urination;

• pain or burning when you urinate;

• new pain, tenderness, sores, ulcers, or infections in your legs or feet;

• high potassium--nausea, irregular heartbeats, weakness, loss of movement;

• ketoacidosis (too much acid in the blood)--nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing; or

• dehydration symptoms--dizziness, weakness, feeling light-headed (like you might pass out).

You may be more likely to have a broken bone while using canagliflozin. Talk with your doctor about how to avoid the risk of fractures.

Side effects may be more likely to occur in older adults.

Common side effects of canagliflozin may include:

• genital infections; or

• urinating more than usual.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• insulin or other oral diabetes medicines;

• a diuretic or "water pill";

• digoxin, digitalis;

• rifampin;

• ritonavir; or

• seizure medication--phenobarbital, phenytoin.

This list is not complete. Other drugs may affect canagliflozin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor will order a lab test before and during your treatment with canagliflozin to check how well your kidneys are working. Your blood sugar levels should be checked regularly to determine your response to canagliflozin. Your doctor will order other lab tests, including glycosylated hemoglobin (HbA1c), to check your response to canagliflozin. 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 canagliflozin. 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.

• Invokamet® (containing Canagliflozin and Metformin)