Jentadueto

linagliptin-metformin
Chemical Name: metformin hydrochloride
Drug Type: antidiabetic combinations

You should not use this medicine if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment).

Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. Stop taking this medicine and get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, trouble breathing, stomach pain, nausea, and feeling very weak or tired.

Linagliptin and metformin are oral diabetes medicines that help control blood sugar levels. Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Linagliptin works by regulating the levels of insulin your body produces after eating.

Linagliptin and metformin is a combination medicine used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. This medicine is not for treating type 1 diabetes.

Linagliptin and metformin may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to metformin (Actoplus Met, Avandamet, Fortamet, Glucophage, Riomet), or:

  • if you have ever had a severe allergic reaction (breathing problems, swelling, severe skin rash) to linagliptin (Tradjenta);
  • if you have severe kidney disease; or
  • if you have diabetic ketoacidosis (call your doctor for treatment).

Some people taking metformin develop a serious condition called lactic acidosis. This may be more likely if you have liver or kidney disease, congestive heart failure, a heart attack or stroke, a severe infection, if you are 65 or older, if you are dehydrated, or if you drink a lot of alcohol. Talk with your doctor about your risk.

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

  • kidney disease (your kidney function may need to be checked before you take this medicine);
  • liver disease;
  • heart disease;
  • a history of pancreatitis;
  • gallstones;
  • high triglycerides (a type of fat in the blood);
  • a history of alcoholism; or
  • if you are over 80 years old and have not recently had your kidney function checked.

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 will need to temporarily stop taking linagliptin and metformin. Be sure your caregivers know ahead of time that you are using this medication.

Follow your doctor's instructions about using this medicine if you are pregnant or breast-feeding a baby. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Your dose needs may also be different while you are breast-feeding.

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

This medicine is not approved for use by anyone younger than 18 years old.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take linagliptin and metformin twice daily with meals, unless your doctor tells you otherwise.

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.

Your doctor may want you to stop taking this medicine for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.

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.

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

Store at room temperature away from moisture and heat.

Take the missed dose as soon as you remember (be sure to take the medicine with food). 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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have signs of low blood sugar, such as extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

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

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

Stop taking this medicine and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, or fast heartbeats.

Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as:

  • muscle pain or weakness;
  • numb or cold feeling in your arms and legs;
  • trouble breathing;
  • feeling dizzy, light-headed, tired, or very weak;
  • stomach pain, nausea with vomiting; or
  • slow or uneven heart rate.

Call your doctor at once if you have:

  • a severe autoimmune reaction--itching, blisters, breakdown of the outer layer of skin;
  • severe or ongoing pain in your joints;
  • swelling, rapid weight gain; or
  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • sore throat;
  • sinus pain, stuffy nose; or
  • diarrhea.

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.

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

  • rifampin (to treat tuberculosis); or
  • insulin or other oral diabetes medicine.

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

Your pharmacist can provide more information about linagliptin and metformin.