Ertugliflozin (er-too-gli-FLOE-zin), Metformin Hydrochloride (met-FOR-min hye-droe-KLOR-ide)

Treats type 2 diabetes.

Brand Name(s):

Segluromet

When This Medicine Should Not Be Used:

How to Use This Medicine:

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.
• 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 medicines can affect how ertugliflozin/metformin works. Tell your doctor about all other medicines that you are using, including the following:
  • Acetazolamide, cimetidine, dichlorphenamide, dolutegravir, isoniazid, lithium, nicotinic acid, phenytoin, ranolazine, vandetanib, zonisamide
  • Birth control pills (including estrogen)
  • Blood pressure medicine
  • Diuretic (water pill)
  • Insulin or another diabetes medicine
  • Medicine to treat mental illness
  • NSAID pain or arthritis medicine (including aspirin, diclofenac, ibuprofen, naproxen)
  • Phenothiazine medicine
  • Steroid medicine
  • Thyroid medicine
• 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 ertugliflozin/metformin.
• Limit the amount of alcohol you drink. Heavy alcohol use or binge drinking increases your risk for lactic acidosis.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant. Do not use this medicine during the second and third part of your pregnancy, unless your doctor tells you to. 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. Talk to your doctor about effective birth control while you are using this medicine.
• Do not breastfeed during treatment with this medicine.
• Tell your doctor if have kidney disease, liver disease, heart failure, blood vessel disease, nerve problems, adrenal or pituitary gland problem, vitamin B12 deficiency, or a history of pancreas problems, leg surgery or foot ulcers, or urinary tract or genital yeast infections. Tell your doctor if you are on a low-salt diet, if you drink alcohol, or if you are having a surgery or other procedures that require fasting.
• This medicine may cause the following problems:
  • Lactic acidosis (too much acid in the blood)
  • Low blood pressure
  • Diabetic ketoacidosis (high ketones and acid in the blood), which can be life-threatening
  • Kidney problems
  • Increased risk of genital yeast or urinary tract infections
  • Increased risk for lower leg or foot amputation (removal)
  • Low blood sugar, when used with other diabetes medicine
  • Fournier's gangrene (skin or tissue damage of the area between the anus and genitals)
• This medicine may cause some patients to become dehydrated. Drink plenty of water every day, during exercise, or in hot weather.
• 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.
• 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. You may need to stop taking this medicine at least 4 days before a surgery.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• 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, chills
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fast or trouble breathing, muscle pain
• Lightheadedness, dizziness, fainting, drowsiness
• Pain, tenderness, redness, or swelling of the genitals or in the area between the anus and genitals, fever, unusual tiredness or weakness
• Pain, tenderness, sores or ulcers, or infections on the leg or foot
• Shaking, trembling, sweating, fast or pounding heartbeat, hunger, confusion

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

• Diarrhea, passing gas, stomach upset
• Headache
• White or yellow vaginal or penile discharge, vaginal or penile 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