When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to dapagliflozin or metformin.

How to Use This Medicine:
Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• If you take the extended-release tablet, part of the tablet may pass into your stools. This is normal and is nothing to worry about.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how dapagliflozin/metformin works. Tell your doctor if you are using any of the following:
  
  • Acetazolamide, amiloride, cimetidine, dichlorphenamide, digoxin, morphine, phenobarbital, phenytoin, procainamide, quinidine, quinine, ranitidine, rifampin, ritonavir, triamterene, trimethoprim, vancomycin, zonisamide
  • Blood pressure medicine
  • Diuretic (water pill)
  • Insulin or other diabetes medicine
  • NSAID pain or arthritis medicine (including aspirin, diclofenac, ibuprofen, naproxen)
• Several other medicines may affect your blood sugar levels. Closely monitor your blood sugar levels when you start or stop another medicine while you are using dapagliflozin/metformin.
• Limit the amount of alcohol you drink. Heavy alcohol use increases your risk for lactic acidosis.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, adrenal or pituitary disease, heart failure, high cholesterol, a vitamin B12 deficiency, or a history of bladder cancer, pancreas problems, or urinary tract or genital yeast infections. Tell your doctor if you are on a low-salt diet.
• This medicine may cause the following problems:
  
  • Lactic acidosis (rare but serious build-up of acid in the blood)
  • Low blood pressure
  • Ketoacidosis (high ketones and acid in the blood)
  • Kidney damage
  • Low blood sugar levels
  • Increased risk of genital yeast or urinary tract infections
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results. This medicine may affect the results of urine glucose tests or interact with the dye used for an x-ray or a CT scan.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, bloody urine, difficult or painful urination, lower back or side pain, fever, chills
• Fast breathing, trouble breathing, stomach pain, nausea, vomiting, severe weakness, tiredness
• Increased hunger, headache, confusion, shaking, trembling, sweating
• Lightheadedness, dizziness, fainting

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Redness, itching, pain, or swelling of the penis, bad-smelling discharge from the penis
• Stuffy or runny nose
• White or yellow vaginal discharge, vaginal itching or odor

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088