Canagliflozin and metformin is a combination medicine used with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Canagliflozin and metformin 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 and metformin 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.

This medicine is not for treating type 1 diabetes.

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

You should not use this medicine if you are allergic to canagliflozin or metformin, or if you have:

• severe kidney disease; or
• ketoacidosis (call your doctor for treatment).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking canagliflozin and metformin.

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;
• liver or kidney disease;
• low levels of vitamin B12 or calcium in your blood;
• bladder infections or other urination problems;
• a pancreas disorder or surgery;
• a change in your diet; or
• if you are on a low salt diet.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

Tell your doctor right away if you become pregnant. Canagliflozin may harm the unborn baby if you take this medicine during your second or third trimester.

Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

You should not breastfeed while using this medicine.

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

Use Invokamet XR (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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.

Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Stop taking this medicine and call your doctor right away if you have unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.

Call your doctor at once if you have:

• new pain, tenderness, sores, ulcers, or infections in your legs or feet;
• little or no urination;
• a light-headed feeling, like you might pass out;
• high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, muscle weakness;
• ketoacidosis (too much acid in the blood)--nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing; or
• signs of a bladder infection--pain or burning when you urinate, urine that looks cloudy, pain in pelvis or back.

Older adults may be more likely to get dehydrated or have kidney problems while taking this medicine.

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

Common side effects may include:

• urinating more than usual;
• headache, weakness;
• gas, stomach pain, indigestion;
• nausea, vomiting; or
• diarrhea.

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.

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.