Dapagliflozin & Metformin hydrochloride

Dapagliflozin/metformin is a prescription medication used to improve blood sugar control in patients with type 2 diabetes. It must be used in conjunction with a healthy diet and exercise plan. Dapagliflozin/metformin is not appropriate for treatment of type 1 diabetes.

It is a single product containing 2 medications: dapagliflozin and metformin. Dapagliflozin belongs to a group of drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors. These work by helping the kidneys get glucose out of the body in the urine. Metformin belongs to a group of drugs called biguanides. These work by decreasing the amount of glucose your body can absorb from food and decreasing the amount of glucose made by the liver.

This medication comes in extended-release tablet form and is taken once a day, in the morning with food.

Do not chew, divide, or break dapagliflozin/metformin tablets. Swallow tablets whole.

Common side effects of dapagliflozin/metformin include yeast infection in females, a cold, urinary tract infection, diarrhea, and headache.

Dapagliflozin/metformin can also cause dizziness. Do not drive or operate heavy machinery until you know how dapagliflozin/metformin affects you.

Serious side effects have been reported with dapagliflozin/metformin. See the “Dapagliflozin/metformin Precautions” section.

Common side effects of dapagliflozin/metformin include the following:

• yeast infection in females
• runny nose and sore throat
• urinary tract infection
• diarrhea
• nausea
• vomiting
• headache

This is not a complete list of Dapagliflozin/metformin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The dose dapagliflozin/metformin for blood glucose control in adults with type 2 diabetes should be initiated at a low dose and slowly increased on the basis of patient response and tolerability. The maximum recommended daily dose of dapagliflozin/metformin is 10 mg dapagliflozin and 2000 mg metformin.

If you take too much dapagliflozin/metformin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If dapagliflozin/metformin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.