Dapagliflozin, Metformin Hydrochloride Oral tablet, extended-release
What is this medicine?
DAPAGLIFLOZIN; METFORMIN (DAP a gli FLOE zin; met FOR min) is a combination of 2 medicines used to treat type 2 diabetes. This medicine lowers blood sugar. Treatment is combined with a balanced diet and exercise.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
diet low in salt
eating less due to illness, surgery, dieting, or any other reason
history of pancreatitis or pancreas problems
history of yeast infection of the penis or vagina
if you often drink alcohol
infections in the bladder, kidneys, or urinary tract
low blood pressure
polycystic ovary syndrome
serious infection or injury
type 1 diabetes
an unusual or allergic reaction to dapagliflozin, metformin, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
Take this medicine by mouth with a glass of water. Take this medicine in the morning with food. Follow the directions on the prescription label. Do not cut, crush, or chew this medicine. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
certain contrast medicines given before X-rays, CT scans, MRI, or other procedures
This medicine may also interact with the following medications:
certain antiviral medicines for HIV infection or hepatitis
female hormones, like estrogens or progestins and birth control pills
medicines for blood pressure, heart disease, irregular heart beat
phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
steroid medicines like prednisone or cortisone
stimulant medicines for attention disorders, weight loss, or to stay awake
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress.
This medicine can cause a serious condition in which there is too much acid in the blood. If you develop nausea, vomiting, stomach pain, unusual tiredness, or breathing problems, stop taking this medicine and call your doctor right away. If possible, use a ketone dipstick to check for ketones in your urine.
A test called the HbA1C (A1C) will be monitored. This is a simple blood test. It measures your blood sugar control over the last 2 to 3 months. You will receive this test every 3 to 6 months.
Learn how to check your blood sugar. Learn the symptoms of low and high blood sugar and how to manage them.
Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. They must get medical help at once.
Tell your doctor or health care professional if you have high blood sugar. You might need to change the dose of your medicine. If you are sick or exercising more than usual, you might need to change the dose of your medicine.
Do not skip meals. Ask your doctor or health care professional if you should avoid alcohol. Many nonprescription cough and cold products contain sugar or alcohol. These can affect blood sugar.
This medicine may cause ovulation in premenopausal women who do not have regular monthly periods. This may increase your chances of becoming pregnant. You should not take this medicine if you become pregnant or think you may be pregnant. Talk with your doctor or health care professional about your birth control options while taking this medicine. Contact your doctor or health care professional right away if think you are pregnant.
If you are going to need surgery, a MRI, CT scan, or other procedure, tell your doctor that you are taking this medicine. You may need to stop taking this medicine before the procedure.
Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.
You may see empty tablets in your stool. This is normal.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
feeling faint or lightheaded, falls
muscle aches or pains
nausea, vomiting, unusual stomach upset or pain
signs and symptoms of low blood sugar such as feeling anxious, confusion, dizziness, increased hunger, unusually weak or tired, sweating, shakiness, cold, irritable, headache, blurred vision, fast heartbeat, loss of consciousness
signs and symptoms of a urinary tract infection, such as fever, chills, a burning feeling when urinating, blood in the urine, back pain
trouble passing urine or change in the amount of urine, including an urgent need to urinate more often, in larger amounts, or at night
penile discharge, itching, or pain in men
slow, irregular heartbeat
unusually tired or weak
vaginal discharge, itching, or odor in women
Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):
mild increase in urination
stuffy or runny nose
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
March 21, 2017
U.S. FDA-approved Package Insert