Canagliflozin-metFORMIN

Canagliflozin and metformin are oral diabetes medicines that help control blood sugar levels. Canagliflozin works by helping the kidneys get rid of glucose from your bloodstream. Metformin lowers glucose production in the liver and also causes your intestines to absorb less glucose.

Canagliflozin and metformin is a combination medicine used together with diet and exercise to treat type 2 diabetes. Canagliflozin 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 have severe kidney disease, if you are on dialysis, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin). Canagliflozin and metformin is not for treating type 1 diabetes.

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

This medicine may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

You should not use this medicine if you are allergic to canagliflozin (Invokana) or metformin (Glucophage, Actoplus Met, Avandamet, Fortamet, Glucovance, Janumet, Jentadueto, Kazano, Kombiglyze, Metaglip, PrandiMet, Riomet), or if you have:

• kidney disease (or if you are on dialysis); or
• if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

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

Some people taking metformin develop a serious condition called lactic acidosis. This may be more likely if you have liver or kidney disease, congestive heart failure, a severe infection, if you are dehydrated, or if you drink large amounts of alcohol. Talk with your doctor about your risk.

To make sure canagliflozin and metformin is safe for you, tell your doctor if you have:

• low blood pressure;
• liver disease;
• heart disease, congestive heart failure;
• a history of stroke or heart attack;
• an electrolyte imbalance (such as high levels of potassium in your blood);
• if you are on a low salt diet; or
• if you are 80 or older and your kidneys have not been tested.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether canagliflozin and metformin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

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

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

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• high potassium--slow heart rate, weak pulse, muscle weakness, tingly feeling;
• ketoacidosis (too much acid in the blood)--nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing;
• signs of a kidney problem--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath;
• signs of a bladder infection--pain or burning when you urinate, urine that looks cloudy, pain in pelvis or back; or
• signs of a genital infection (penis or vagina)--pain, burning, itching, rash, redness, odor, or discharge.

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

You may be more likely to have bone fractures (even after only a minor impact trauma) while you are taking medicine that contains canagliflozin. Talk with your doctor about how to avoid the risk of fractures.

Common side effects may include:

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

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.

Your doctor may perform kidney function tests before you start taking canagliflozin and metformin.

This medicine is usually taken 2 times per day with meals. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Your doctor may have you take extra vitamin B12 while you are taking canagliflozin and metformin. Take only the amount of vitamin B12 that your doctor has prescribed.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medicine, which can lead to severely low blood pressure or a serious electrolyte imbalance.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.

If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor's advice.

If you need to fast (stop eating) before a surgery, tell the surgeon ahead of time that you take canagliflozin and metformin. You may need to stop using the medicine for a short time.

Canagliflozin and metformin can cause positive results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using canagliflozin.

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

Store tablets in their original container at room temperature, away from moisture and heat. Do not put canagliflozin and metformin tablets into a daily pill box.

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

An overdose of metformin may cause lactic acidosis. Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.

Take the missed dose as soon as you remember (be sure to take the medicine with food). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Pregnancy Category: C

Canagliflozin: Based on studies in rats, may affect renal development

Metformin: Metformin was not teratogenic in rats and rabbits at doses up to 600 mg/kg/day; determination of fetal concentrations demonstrated a partial placental barrier to metformin

Lactation: Unknown if canagliflozin is distributed in human breast milk; metformin is excreted into milk in rats and reaches levels comparable to those in plasma; breastfeeding not recommended

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.