Dapagliflozin and metformin

Dapagliflozin and metformin is a combination medicine that, along with diet and exercise, helps adults with type 2 diabetes mellitus manage their blood sugar levels. Dapagliflozin and metformin is not for treating type 1 diabetes.

Dapagliflozin and metformin is also used to reduce the risk of being hospitalized for heart failure in adults with type 2 diabetes who also have heart disease.

Dapagliflozin and metformin is also used to lower the risk of worsening kidney disease and death from heart issues, as well as the need for hospitalization due to heart failure in adults with type 2 diabetes who also have chronic kidney disease.

Dapagliflozin and metformin may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may sometimes change your dose. Use the medicine exactly as directed.

Take with food to avoid an upset stomach.

Swallow the tablet whole and do not crush, chew, or break it.

You may experience low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Make sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking dapagliflozin and metformin, which can lead to severely low blood pressure or a serious electrolyte imbalance.

If you need surgery or medical tests, inform any doctor who treats you that you are using dapagliflozin and metformin.

This medicine is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Your kidney function may need to be checked during treatment with dapagliflozin and metformin.

Your doctor may have you take extra vitamin B12 while you are taking dapagliflozin and metformin. Take only the amount of vitamin B12 that your doctor has prescribed.

Store at room temperature, away from moisture and heat.

You may develop lactic acidosis, which is a dangerous build-up of lactic acid in your blood. Call your doctor or seek emergency medical help if you experience unusual muscle pain, difficulty breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

In rare cases, dapagliflozin and metformin can cause serious infections in the penis or vagina. Get medical help immediately if you have burning, itching, odor, discharge, pain, tenderness, redness, or swelling of the genital or rectal area, fever, or if you feel unwell.

You should not use this medicine if you are allergic to dapagliflozin (Farxiga) or metformin, or if you have

• severe kidney disease (or if you are on dialysis); or
• metabolic acidosis or diabetic ketoacidosis (call your doctor for treatment).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking dapagliflozin and metformin.

Tell your doctor if you have ever had:

• liver or kidney disease;
• a bladder infection or urination problems;
• heart problems, low blood pressure;
• problems with your pancreas, including surgery; or
• if you are on a low salt diet.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

Follow your doctor's instructions about using this medicine if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester.

Tell your doctor right away if you become pregnant. You should not use dapagliflozin and metformin during the second or third trimester of pregnancy.

Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

You should not breastfeed while using this medicine.

Dapagliflozin and metformin is not approved for use by anyone younger than 18 years old.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Seek medical attention right away if you have signs of a genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well. These symptoms may worsen quickly.

Dapagliflozin and metformin may cause serious side effects. Call your doctor immediately if you have:

• little or no urination;
• signs of a bladder infection--pain or burning when you urinate, increased urination, blood in your urine, fever, pain in your pelvis or back;
• dehydration symptoms--dizziness, weakness, feeling light-headed (like you might faint);
• ketoacidosis (too much acid in the blood)--nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing; or
• lactic acidosis--unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.

Side effects may be more likely to happen in older adults.

Common side effects of dapagliflozin and metformin may include:

• genital infections;
• headache;
• nausea, vomiting, diarrhea; or
• runny or stuffy nose, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take the medicine (with food) as soon as you remember. If it is nearly time for your next dose, skip the missed dose. Do not take two doses at once.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. You may have very low blood sugar if you experience extreme weakness, nausea, tremors, sweating, confusion, trouble speaking, fast heartbeats, or seizures.

Avoid drinking alcohol. It can lower blood sugar and may increase your risk of lactic acidosis.

Be careful not to get up too quickly from a sitting or lying position, as this may cause dizziness.

Tell your doctor about all your other medicines, especially:

• digoxin (digitalis, Lanoxin);
• rifampin;
• phenytoin;
• a diuretic or "water pill";
• insulin or other oral diabetes medications; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may affect dapagliflozin and metformin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.