Ertugliflozin/Sitagliptin Oral Tablet (ERTUGLIFLOZIN/SITAGLIPTIN - ORAL)

Instructions

This medicine may be taken with or without food.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Drink plenty of water while on this medicine.

Tell your doctor if you have severe or persistent sweating, diarrhea or vomiting. These can increase your risk of a serious side effect.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

This medicine may cause low blood sugar. Eat regular meals and exercise as instructed by your doctor. Tell your doctor if you have symptoms of low blood sugar such as nausea, sweating, cold skin, fast heartbeat, hunger, and irritability.

If you have diabetes and use urine glucose tests, this medicine may cause incorrect results. Please check with your doctor before making any changes to your diabetes treatment plan.

Keep all appointments for medical exams and tests while on this medicine.

Do not take the medicine more than once during 24 hours.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients with weak hearts may have worsening of symptoms. If you notice difficulty breathing, weight gain, or swelling of your legs or ankles, let your doctor know right away.

This medicine is associated with a rare but very serious medical condition. Please speak with your doctor about symptoms you should look out for while on this medicine. Notify your doctor immediately if you develop those symptoms.

This medicine may rarely increase risk of losing a lower limb. This may result in loss of a toe, foot, or leg. Please speak with your doctor whether you are at risk. If you notice any pain, redness, swelling, or sores on your leg or foot, contact your doctor right away.

Do not use the medication any more than instructed.

This medicine may cause dizziness or fainting. Do not stand or sit up quickly.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Please check with your doctor before drinking alcohol while on this medicine.

Avoid becoming overheated during exercise or other activities. Try to stay cool in hot weather.

It is unknown if this medicine passes into breast milk. Ask your doctor before breastfeeding.

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• dizziness
• low blood sugar
• increased urinary frequency
• waking up at night to urinate

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• blurry vision
• dry mouth
• swelling of the legs, feet, and hands
• feeling cold or numb, especially in arms and legs
• fever or chills
• numbness or tingling in hands and feet
• fast or irregular heart beats
• pain in the joints
• signs of kidney damage (such as change in urine color or bubbly urine)
• nausea and vomiting
• pale or blue skin, lips or fingernails
• shortness of breath
• red, peeling or blistering skin
• severe stomach pain that spreads to the back
• excessive thirst
• unusual or unexplained tiredness or weakness
• urinary tract infections
• difficulty or discomfort urinating
• blood in urine
• vaginal dryness or irritation
• vaginal itching or discharge
• sudden or unexplained weight gain
• yeast infection of the penis (redness, itching, swelling or discharge)

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.