empagliflozin and linagliptin

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Pronunciation: EM pa gli FLOE zin and LIN a GLIP tin

Brand: Glyxambi

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

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

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.

What is empagliflozin and linagliptin?

Empagliflozin and linagliptin are oral diabetes medicines that help control blood sugar levels. Empagliflozin works by helping the kidneys get rid of glucose from your bloodstream. Linagliptin works by regulating the levels of insulin your body produces after eating.

Empagliflozin and linagliptin is a combination medicine used together with diet and exercise to improve blood sugar control in adults with diabetes mellitus.

Empagliflozin and linagliptin 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.

This medicine is not for treating type 1 diabetes.

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

What should I discuss with my healthcare provider before taking empagliflozin and linagliptin?

You should not use empagliflozin and linagliptin if you are allergic to it, 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
  • if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure empagliflozin and linagliptin is safe for you, tell your doctor if you have ever had:

  • heart problems;
  • kidney disease;
  • liver disease;
  • a pancreas disorder;
  • low blood pressure;
  • gallstones;
  • high cholesterol or triglycerides (a type of fat in the blood);
  • alcoholism;
  • a genital infection (penis or vagina);
  • if you are on a low salt diet; or
  • if you are 65 or older.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether empagliflozin and linagliptin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take empagliflozin and linagliptin?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Empagliflozin and linagliptin is usually taken in the morning. You may take this medicine with or without food.

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.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and 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, blurred vision, headache, and tiredness.

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 cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using empagliflozin and linagliptin.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An empagliflozin and linagliptin 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 empagliflozin and linagliptin?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

What are the possible side effects of empagliflozin and linagliptin?

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.

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

  • severe or ongoing pain in your joints;
  • 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, or light-headed feeling (like you might pass out);
  • signs of a bladder infection --pain or burning when you urinate, urine that looks cloudy, pain in pelvis or back;
  • signs of a genital infection (penis or vagina) --pain, burning, itching, rash, redness, odor, or discharge; 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:

  • urination problems;
  • sore throat; or
  • runny nose, stuffy nose, sinus pain.

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 empagliflozin and linagliptin?

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

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

This list is not complete. Other drugs may interact with empagliflozin and linagliptin, 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 and linagliptin.

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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