Dapagliflozin Propanediol (dap-a-gli-FLOE-zin proe-pane-DYE-ol), Metformin Hydrochloride (met-FOR-min hye-droe-KLOR-ide), Saxagliptin (sax-a-GLIP-tin)

Treats type 2 diabetes.

Brand Name(s):

When This Medicine Should Not Be Used:

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. Take this medicine in the morning.
• 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: If you miss a dose and it is less than 12 hours until your next regular dose, skip the missed dose and take your next dose at the regular time. If you miss a dose and it is 12 hours or more until your next regular dose, take the missed dose as soon as possible, and then go back to your regular schedule.
• 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 medicines can affect how this medicine works. Tell your doctor about all other medicines that you are using, including the following:
  • Acetazolamide, atazanavir, cimetidine, clarithromycin, dichlorphenamide, dolutegravir, indinavir, isoniazid, itraconazole, ketoconazole, nefazodone, nelfinavir, nicotinic acid, phenytoin, ranolazine, ritonavir, saquinavir, telithromycin, vandetanib, zonisamide
  • Birth control pills (including estrogen)
  • Blood pressure medicine
  • Diuretic (water pill)
  • Insulin or other oral diabetes medicine
  • NSAID pain or arthritis medicine (including aspirin, diclofenac, ibuprofen, naproxen)
  • Phenothiazine medicine
  • Steroid medicine
  • Thyroid medicine
• Limit how much alcohol you drink.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding. If you had problems ovulating or have irregular periods, this medicine may cause you to ovulate, which could lead to pregnancy if you are sexually active. Also, you should not use this medicine during the last 6 months of pregnancy. Talk to your doctor about effective birth control while you are using this medicine.
• Tell your doctor if you have kidney disease, liver disease, heart disease, heart failure, vitamin B12 deficiency, a history of pancreas problems, genital yeast or urinary tract infections, or alcohol abuse.
• This medicine may cause the following problems:
  • Pancreatitis (swelling of the pancreas)
  • Lactic acidosis (too much acid in the blood)
  • Heart failure
  • Low blood pressure
  • Ketoacidosis (high ketones and acid in the blood), which can be life-threatening
  • Kidney problems
  • Increased risk of genital yeast or urinary tract infections
  • Low blood sugar, when used with other diabetes medicines
  • Fournier's gangrene (skin or tissue damage of the area between the anus and genitals)
  • Serious skin reactions
  • High cholesterol level
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests. Your doctor may advise you to stop taking this medicine at least 3 days before a surgery.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may 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
• Blistering, peeling, red skin rash, large, hard skin blisters
• Change in how much or how often you urinate, bloody urine, painful or difficult urination, lower back or side pain, chills
• Fast or troubled breathing, severe weakness, tiredness, or confusion
• Increased hunger, headache, shaking, trembling, sweating
• Lightheadedness, dizziness, fainting
• Pain, tenderness, redness, or swelling of the area between the anus and genitals, fever
• Rapid weight gain, swelling in your hands, ankles, or feet
• Severe joint pain
• Sudden and severe stomach pain, nausea, vomiting

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

• Cough, stuffy or runny nose, sore throat
• Redness, itching, pain, or swelling of the penis, bad-smelling discharge from the penis
• 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