Empagliflozin (em-pa-gli-FLOE-zin), Linagliptin (lin-a-GLIP-tin)

Treats type 2 diabetes and lowers the risk of death in patients with type 2 diabetes and heart or blood vessel disease.

Brand Name(s):

Glyxambi

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. This medicine is usually taken in the morning.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how empagliflozin/linagliptin works. Tell your doctor if you are using any of the following:
  • Lithium, rifampin
  • Blood pressure medicine
  • Diuretic (water pill)
  • Insulin or other diabetes medicine
  • NSAID pain or arthritis medicine (including aspirin, celecoxib, diclofenac, ibuprofen, naproxen)
• Limit the amount of alcohol you drink.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant. Do not use this medicine during the second and third part of your pregnancy, unless your doctor tells you to.
• Do not breastfeed during treatment with this medicine.
• Tell your doctor if you have kidney disease, a history of pancreas problems, heart failure, urinary tract or genital yeast infections, leg problems (including amputation, blood vessel disease), or foot infection, sores, or ulcers. Tell your doctor if you drink alcohol, if you are on a low-salt diet, or if you are having surgery or other procedures that require fasting.
• This medicine may cause the following problems:
  • Pancreatitis (swelling of the pancreas)
  • Heart failure
  • Low blood pressure
  • Ketoacidosis (high ketones and acid in the blood), which can be life-threatening
  • Kidney problems
  • Low blood sugar, when used with other diabetes medicines
  • Increased risk of genital yeast or urinary tract infections
  • Increased risk for leg, foot, or toe amputation (removal)
  • Fournier's gangrene (skin or tissue damage of the area between the anus and genitals)
  • Serious skin reactions
• This medicine may cause some patients to become dehydrated. Drink plenty of water every day, during exercise, or in hot weather.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, bloody urine, painful or difficult urination, lower back or side pain, chills
• Fast or trouble breathing, cold sweat, bluish-colored skin
• Increased hunger, headache, confusion, shaking, trembling, sweating
• Large, hard skin blisters
• Lightheadedness, dizziness, fainting
• Pain, tenderness, redness, or swelling of the area between the anus and genitals, fever, unusual tiredness or weakness
• Pain, tenderness, sores or ulcers, or infections on the leg or foot
• Rapid weight gain, swelling in your hands, ankles, or feet
• Severe joint pain
• Sudden or severe stomach pain, nausea, vomiting

If you notice these less serious side effects, talk with your doctor:

• Cough, stuffy or runny nose, sore throat
• Redness, itching, pain, or swelling of the penis, bad-smelling discharge from the penis
• White or yellowish vaginal discharge, vaginal itching or odor

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088