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empagliflozin, linagliptin, and metformin

Pronunciation: EM pa gli FLOE zin, LIN a GLIP tin, and met FOR min

Brand: Trijardy XR

What is the most important information I should know about empagliflozin, linagliptin, and metformin?

You should not use this medicine if you have severe kidney disease (or if you are on dialysis) or diabetic ketoacidosis, or if you have ever had a severe allergic reaction to empagliflozin or linagliptin.

Call your doctor at once if you have signs of a serious side effect, such as severe pain in your upper stomach spreading to your back, vomiting, fast heart rate, dizziness, feeling very thirsty or hot, decreased urination, heavy sweating, or hot and dry skin.

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

In rare cases, this medicine can cause serious infections in the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or if you don't feel well.

What is empagliflozin, linagliptin, and metformin?

Empagliflozin, linagliptin, and metformin (Trijardy XR) is a combination medicine used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Trijardy XR is also used to lower the risk of death from heart attack, stroke, or heart failure in adults with type 2 diabetes who also have heart disease.

Trijardy XR is not for treating type 1 diabetes.

Empagliflozin, linagliptin, and metformin may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking Trijardy XR?

You should not use this medicine if you are allergic to empagliflozin, linagliptin, or metformin, or if you have:

  • severe kidney disease (or if you are on dialysis);
  • a history of severe allergic or skin reaction after taking linagliptin; or
  • metabolic acidosis or diabetic ketoacidosis (call your doctor for treatment).

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking this medicine. Be sure your caregivers know ahead of time that you are using this medication.

Tell your doctor if you have ever had:

  • liver or kidney disease;
  • a bladder infection or urination problems;
  • a pancreas disorder;
  • heart failure, low blood pressure;
  • gallstones;
  • alcoholism;
  • a genital infection (penis or vagina);
  • if you are on a low salt diet; or
  • if you are 65 or older.

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 or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

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.

How should I take Trijardy XR?

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

Trijardy XR is usually taken in the morning with a meal.

Swallow the tablet whole and do not crush, chew, break, or dissolve it. Tell your doctor if you have trouble swallowing the tablet.

Tell your doctor if you notice a tablet in your stool that was not absorbed or melted in the body. Your blood sugar levels may need to be checked to be sure this medicine is working well.

Your blood sugar will need to be checked often, and you may also need to test the level of ketones your urine. Empagliflozin can cause life-threatening ketoacidosis (too much acid in the blood). Even if your blood sugar is normal, contact your doctor if a urine test shows that you have ketones in the urine.

You may have 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. Be 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.

This medicine can affect the results of certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Trijardy XR.

Store at room temperature away from moisture and heat.

Your doctor may have you take extra vitamin B12 while you are taking Trijardy XR. Take only the amount of vitamin B12 your doctor has prescribed.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can cause life threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, confusion, tremors, sweating, fast heart rate, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure (convulsions).

What should I avoid while taking Trijardy XR?

Avoid drinking alcohol. It may increase your risk of lactic acidosis.

What are the possible side effects of Trijardy XR?

Get emergency medical help if you have signs of an allergic reaction: hives, itching, flaking or peeling skin; trouble swallowing, difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical attention right away if you have signs of a rare but serious 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 get worse quickly.

Stop taking this medicine and call your doctor at once if you have:

  • severe or ongoing pain in your joints;
  • lactic acidosis --unusual muscle pain, trouble breathing, stomach pain, vomiting, slow or irregular heart rate, dizziness, feeling cold, or feeling very weak or tired;
  • serious skin reaction --itching, blisters, breakdown of the outer layer of skin;
  • ketoacidosis (too much acid in the blood) --nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing;
  • pancreatitis --severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • dehydration symptoms --dizziness, weakness, feeling light-headed (like you might pass out);
  • signs of a bladder infection --pain or burning when you urinate, blood in your urine, pain in pelvis or back; or
  • symptoms of heart failure --shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain.

Common side effects may include:

  • stomach pain, diarrhea, constipation;
  • a bladder infection;
  • headache; or
  • cold symptoms such as stuffy nose, sneezing, 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.

What other drugs will affect Trijardy XR?

Other drugs may increase or decrease the effects of empagliflozin, linagliptin, and metformin on lowering your blood sugar. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • insulin, or other oral diabetes medicine;
  • rifampin (to treat tuberculosis); or
  • a diuretic or "water pill."

This list is not complete. Other drugs may affect empagliflozin, linagliptin, and metformin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about empagliflozin, linagliptin, and metformin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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