Dapagliflozin; Saxagliptin; Metformin extended-release tablets

What is this medication?

DAPAGLIFLOZIN; SAXAGLIPTIN; METFORMIN (DAP a gli FLOE zin; SAX a glip tin; met FOR min) is a combination of 3 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.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• anemia
• bladder cancer
• dehydration
• diabetic ketoacidosis
• diet low in salt
• eating less due to illness, surgery, dieting, or any other reason
• having surgery
• heart disease
• heart failure
• high cholesterol
• 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
• kidney disease
• liver disease
• low blood pressure
• on hemodialysis
• polycystic ovary syndrome
• previous swelling of the tongue, face, or lips with difficulty breathing, difficulty swallowing, hoarseness, or tightening of the throat
• problems urinating
• serious infection or injury
• type 1 diabetes
• uncircumcised male
• vomiting
• an unusual or allergic reaction to dapagliflozin, saxagliptin, metformin, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

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 have 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.

Overdosage: If you think you have 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 and it is 12 hours or more until the next dose, the dose should be taken. If it is less than 12 hours until the next dose, skip the missed dose and take the next dose at the usual time. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• Certain contrast medications given before X-rays, CT scans, MRI, or other procedures
• Dofetilide

This medicine may also interact with the following medications:

• Acetazolamide
• Alcohol
• Certain antibiotics, such as clarithromycin, telithromycin
• Certain antivirals for HIV or hepatitis
• Certain medicines for blood pressure, heart disease, irregular heart beat
• Certain medicines for fungal infections, such as ketoconazole, itraconazole
• Cimetidine
• Dichlorphenamide
• Digoxin
• Diuretics
• Estrogen or progestin hormones
• Glycopyrrolate
• Isoniazid
• Lamotrigine
• Lithium
• Memantine
• Methazolamide
• Metoclopramide
• Midodrine
• Nefazodone
• Niacin
• Phenobarbital
• Phenothiazines, such as chlorpromazine, prochlorperazine, thioridazine
• Phenytoin
• Ranolazine
• Rifampin
• Steroid medicines, such as prednisone or cortisone
• Stimulant medicines for attention disorders, weight loss, or staying awake
• Thyroid medications
• Topiramate
• Trospium
• Vandetanib
• Zonisamide

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 medication?

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 you 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.

This medicine may cause a decrease in folic acid and vitamin B12. You should make sure that you get enough vitamins while you are taking this medicine. Discuss the foods you eat and the vitamins you take with your health care professional.

What side effects may I notice from receiving this medication?

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
• breathing problems
• feeling faint or lightheaded, falls
• penile discharge, itching, or pain in men
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• signs and symptoms of a genital infection, such as fever; tenderness, redness, or swelling in the genitals or area from the genitals to the back of the rectum
• signs and symptoms of a urinary tract infection, such as fever, chills, a burning feeling when urinating, blood in the urine, back pain
• signs and symptoms of heart failure like breathing problems, fast, irregular heartbeat, sudden weight gain; swelling of the ankles, feet, hands; unusually weak or tired
• 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 muscle injury like dark urine; trouble passing urine or change in the amount of urine; unusually weak or tired; muscle pain; back pain
• slow or irregular heartbeat
• an urgent need to urinate more often, in larger amounts, or at night
• unusual stomach upset or pain
• vaginal discharge, itching, or odor in women
• vomiting

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• headache
• mild increase in urination
• nausea
• sore throat
• 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.

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 medication?

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.