Dapagliflozin/Metformin Extended Release Oral Tablet (DAPAGLIFLOZIN/METFORMIN EXTENDED-RELEASE - ORAL)

Instructions

Swallow the medicine without crushing or chewing it.

Take the medicine with a meal.

You may take with food to prevent stomach upset.

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.

It may take several weeks for this medicine to fully work.

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.

This medicine usually does not cause low blood sugar levels if you eat regular meals.

This medicine may cause menstrual changes and make it easier to become pregnant. Speak with your healthcare provider about effective birth control options.

Parts of this medicine may come out in the stool. This is normal.

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.

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.

Do not use the medication any more than instructed.

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.

If you drink more than a few alcoholic beverages each day, ask your doctor whether you should be on this medicine.

Contact your doctor if you notice a change in the amount or darkening of your urine.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

Always carry an ID card or wear a medical alert bracelet indicating your medical condition.

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.

The side effects may improve with continued use.

Always refill this medicine before it runs out.

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.

• bloating
• diarrhea
• excess gas
• headaches
• low blood sugar
• nausea and vomiting
• runny nose
• sore throat
• stomach upset or abdominal pain

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

• irregular heart beat
• severe, watery or bloody diarrhea
• dizziness
• swelling of the legs, feet, and hands
• fever or chills
• numbness or tingling in hands and feet
• fast, irregular, or slow heartbeat
• muscle pain
• pale or blue skin, lips or fingernails
• rapid breathing
• shortness of breath
• severe stomach or bowel pain
• unusual or unexplained tiredness or weakness
• increased urinary frequency
• urinary tract infections
• waking up at night to urinate
• urinating less often
• difficulty or discomfort urinating
• blood in urine
• dark urine
• vaginal itching or yeast infection
• blurring or changes of vision
• severe or persistent vomiting
• 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.