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 saxagliptin 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. Take this medicine with the evening meal, unless your doctor tells you otherwise.
• 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.
• Drink plenty of fluids to help prevent dehydration.
• Missed dose: Skip the missed dose and take your next dose at the regularly scheduled time. 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 saxagliptin/metformin works. Tell your doctor if you are using any of the following:
  
  • Amiloride, cimetidine, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin
  • Atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin
  • Blood pressure medicine, including beta-blocker medicine
  • Insulin or other diabetes medicine
• Some medicines may affect your blood sugar level, including a diuretic (water pill), birth control pills, corticosteroid (including dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone), phenothiazine medicine (including chlorpromazine, perphenazine, prochlorperazine, promethazine, thioridazine), thyroid medicine, niacin, and isoniazid.
• Limit the amount of alcohol you drink. Too much alcohol increases your risk of lactic acidosis.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, vitamin B12 deficiency, heart failure, adrenal or pituitary gland disease, high cholesterol, or a history of gallstones, or alcoholism.
• This medicine may cause the following problems:
  
  • Lactic acidosis (rare but serious build-up of acid in the blood)
  • Pancreatitis
  • Heart failure
  • Low blood sugar and vitamin B12 levels
  • Serious allergic reactions, including skin reactions
• 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.
• 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.
• 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, or red skin rash
• Fast breathing, trouble breathing, nausea and vomiting, lightheadedness, severe weakness, tiredness, or confusion
• Rapid weight gain, swelling in your hands, ankles, or feet
• Severe joint pain
• Shaking, trembling, sweating, fast or pounding heartbeat, faintness, hunger, confusion
• Sudden and severe stomach pain, nausea, vomiting, fever, lightheadedness

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

• Cough, stuffy or runny nose
• Headache

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