FOR U.S. RESIDENTS ONLY AGE 18 AND OVER

Side Effects

What are severe potential side effects of Jentadueto

The most severe potential side effect is lactic acidosis

Another serious side effect is inflammation of the pancreas (pancreatitis)

Serious side effects may include low blood sugar (hypoglycemia)

JENTADUETO may cause low blood sugar, especially when taken with another medicine that can cause low blood sugar

Allergic reactions can occur up to 3 months after starting Jentadueto

Allergic (hypersensitivity) reactions can happen after your first dose or up to 3 months after starting JENTADUETO

SOME PEOPLE DEVELOP JOINT PAIN THAT CAN BE SEVERE

SOME PEOPLE DEVELOP JOINT PAIN THAT CAN BE SEVERE

Allergic reactions can occur up to 3 months after starting Jentadueto

Some people may develop a serious skin reaction while taking JENTADUETO or JENTADUETO XR

Common side effects of Jentadueto® (linagliptin / metformin HCI)

The most common side effects include stuffy or runny nose, sore throat, and diarrhea

Serious side effects can happen in people taking JENTADUETO, including:

Lactic Acidosis

Metformin, one of the medicines in JENTADUETO can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.

Call your doctor right away if you feel cold in your hands or feet, feel dizzy or lightheaded, have a slow or irregular heartbeat, feel very weak or tired, have unusual (not normal) muscle pain, have trouble breathing, feel sleepy or drowsy, have stomach pains, nausea or vomiting as these could be symptoms of lactic acidosis.

Most people who have had lactic acidosis with metformin have other things that, combined with metformin, led to the lactic acidosis. Tell your doctor if you have had severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye, have liver problems, drink alcohol very often, or drink a lot of alcohol in short-term (“binge” drinking), get dehydrated (lose a large amount of body fluids), have surgery, or have a heart attack, severe infection, or stroke. The best way to keep from having a problem with lactic acidosis from metformin is to tell your doctor if you have any of the problems in the list above.

Pancreatitis

Inflammation of the pancreas (pancreatitis) is another serious side effect that can happen to people taking JENTADUETO. Pancreatitis may be severe and lead to death. Before you start taking JENTADUETO tell your doctor if you have ever had pancreatitis, gallstones, a history of alcoholism, or high triglyceride levels.

Stop taking JENTADUETO and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

Low Blood Sugar

JENTADUETO may cause low blood sugar (hypoglycemia), especially if you take JENTADUETO with another medicine that can cause low blood sugar, such as sulfonylurea or insulin. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, or feeling jittery.

Serious Allergic Reactions

Allergic (hypersensitivity) reactions can happen after your first dose or up to 3 months after starting JENTADUETO. Symptoms may include swelling of your face, lips, throat, and other areas on your skin; difficulty with swallowing or breathing; raised, red areas on your skin (hives); skin rash, itching, flaking, or peeling. If you have any symptoms of a serious allergic reaction, stop taking JENTADUETO and call your doctor or go to the emergency room right away.

Joint Pain

Some people who take medicines called DPP-4 inhibitors, one of the medicines in JENTADUETO, may develop joint pain that can be severe. Call your doctor if you have severe joint pain.

Skin Reaction

Some people who take medicines called DPP-4 inhibitors, one of the medicines in JENTADUETO and JENTADUETO XR, may develop a skin reaction. Tell your doctor right away if you develop blisters.

Most Common Side Effects

The most common side effects of JENTADUETO include stuffy or runny nose, sore throat, and diarrhea. These are not all the possible side effects of JENTADUETO. For more information, ask your doctor or pharmacist.

What are JENTADUETO and JENTADUETO XR?

JENTADUETO and JENTADUETO XR are prescription medicines that contain 2 diabetes medicines, linagliptin (TRADJENTA) and metformin hydrochloride. JENTADUETO and JENTADUETO XR can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

JENTADUETO and JENTADUETO XR are not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine). If you have had inflammation of the pancreas (pancreatitis) in the past, it is not known if you have a higher chance of getting pancreatitis while you take JENTADUETO or JENTADUETO XR.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about JENTADUETO or JENTADUETO XR?

JENTADUETO and JENTADUETO XR can cause serious side effects, including Lactic Acidosis (a build-up of lactic acid in the blood). Metformin, one of the medicines in JENTADUETO and JENTADUETO XR, can cause lactic acidosis, a rare but serious condition that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.

Stop taking JENTADUETO or JENTADUETO XR and call your doctor right away or go to the nearest hospital emergency room if you get any of the following symptoms, which could be signs of lactic acidosis: feel very weak and tired, have unusual muscle pain, have trouble breathing, have stomach or intestinal problems with nausea and vomiting, or diarrhea, feel sleepy or sleep longer than usual, feel cold in your arms and legs, feel dizzy or lightheaded, or have a slow or irregular heartbeat.

You have a higher chance of getting lactic acidosis with JENTADUETO or JENTADUETO XR if you have severe kidney problems, liver problems, drink a lot of alcohol (very often or short-term "binge" drinking), get dehydrated (lose a large amount of body fluids), have x-ray tests with injectable dye, have surgery, have congestive heart failure, have a heart attack, severe infection, or stroke, or are 65 years of age or older.

Inflammation of the pancreas (pancreatitis) is another serious side effect that can happen to people taking JENTADUETO or JENTADUETO XR. Pancreatitis may be severe and lead to death. Before you start taking JENTADUETO or JENTADUETO XR tell your doctor if you have ever had pancreatitis, gallstones, a history of alcoholism, or high triglyceride levels.

Stop taking JENTADUETO or JENTADUETO XR and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

Heart failure. Heart failure means your heart does not pump blood well enough. Before you start taking JENTADUETO or JENTADUETO XR, tell your doctor if you have ever had heart failure or have problems with your kidneys. Contact your doctor right away if you have any of the following symptoms: increasing shortness of breath or trouble breathing, especially when you lie down; swelling or fluid retention, especially in the feet, ankles, or legs; an unusually fast increase in weight or unusual tiredness. These may be symptoms of heart failure.

Who should not take JENTADUETO or JENTADUETO XR?

Do not take JENTADUETO or JENTADUETO XR if you:


What should I tell my doctor before using JENTADUETO or JENTADUETO XR?

Tell your doctor about all of your medical conditions, including if you:

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. JENTADUETO or JENTADUETO XR may affect the way other medicines work, and other medicines may affect how JENTADUETO or JENTADUETO XR works.

Especially tell your doctor if you take:

What are the possible side effects of JENTADUETO and JENTADUETO XR?

JENTADUETO and JENTADUETO XR may cause serious side effects, including:

The most common side effects of JENTADUETO and JENTADUETO XR include stuffy or runny nose, sore throat, and diarrhea.

These are not all the possible side effects of JENTADUETO and JENTADUETO XR. For more information, ask your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑10881‑800‑FDA‑1088.

CL-JD-100022 03.30.2020

Please see Prescribing Information, including Boxed Warning about lactic acidosis, and Medication Guide for JENTADUETO.
Please see Prescribing Information, including Boxed Warning about lactic acidosis, and Medication Guide for JENTADUETO XR.

What are JENTADUETO and JENTADUETO XR?

JENTADUETO and JENTADUETO XR are prescription medicines that contain 2 diabetes medicines, linagliptin (TRADJENTA) and metformin hydrochloride. JENTADUETO and JENTADUETO XR can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

JENTADUETO and JENTADUETO XR are not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine). If you have had inflammation of the pancreas (pancreatitis) in the past, it is not known if you have a higher chance of getting pancreatitis while you take JENTADUETO or JENTADUETO XR.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about JENTADUETO or JENTADUETO XR?

JENTADUETO and JENTADUETO XR can cause serious side effects, including Lactic Acidosis (a build-up of lactic acid in the blood). Metformin, one of the medicines in JENTADUETO and JENTADUETO XR, can cause lactic acidosis, a rare but serious condition that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.

Stop taking JENTADUETO or JENTADUETO XR and call your doctor right away or go to the nearest hospital emergency room if you get any of the following symptoms, which could be signs of lactic acidosis: feel very weak and tired, have unusual muscle pain, have trouble breathing, have stomach or intestinal problems with nausea and vomiting, or diarrhea, feel sleepy or sleep longer than usual, feel cold in your arms and legs, feel dizzy or lightheaded, or have a slow or irregular heartbeat.

You have a higher chance of getting lactic acidosis with JENTADUETO or JENTADUETO XR if you have severe kidney problems, liver problems, drink a lot of alcohol (very often or short-term "binge" drinking), get dehydrated (lose a large amount of body fluids), have x-ray tests with injectable dye, have surgery, have congestive heart failure, have a heart attack, severe infection, or stroke, or are 65 years of age or older.

Inflammation of the pancreas (pancreatitis) is another serious side effect that can happen to people taking JENTADUETO or JENTADUETO XR. Pancreatitis may be severe and lead to death. Before you start taking JENTADUETO or JENTADUETO XR tell your doctor if you have ever had pancreatitis, gallstones, a history of alcoholism, or high triglyceride levels.

Stop taking JENTADUETO or JENTADUETO XR and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

Heart failure. Heart failure means your heart does not pump blood well enough. Before you start taking JENTADUETO or JENTADUETO XR, tell your doctor if you have ever had heart failure or have problems with your kidneys. Contact your doctor right away if you have any of the following symptoms: increasing shortness of breath or trouble breathing, especially when you lie down; swelling or fluid retention, especially in the feet, ankles, or legs; an unusually fast increase in weight or unusual tiredness. These may be symptoms of heart failure.

Who should not take JENTADUETO or JENTADUETO XR?

Do not take JENTADUETO or JENTADUETO XR if you:


What should I tell my doctor before using JENTADUETO or JENTADUETO XR?

Tell your doctor about all of your medical conditions, including if you:

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. JENTADUETO or JENTADUETO XR may affect the way other medicines work, and other medicines may affect how JENTADUETO or JENTADUETO XR works.

Especially tell your doctor if you take:

What are the possible side effects of JENTADUETO and JENTADUETO XR?

JENTADUETO and JENTADUETO XR may cause serious side effects, including:

The most common side effects of JENTADUETO and JENTADUETO XR include stuffy or runny nose, sore throat, and diarrhea.

These are not all the possible side effects of JENTADUETO and JENTADUETO XR. For more information, ask your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑10881‑800‑FDA‑1088.

CL-JD-100022 03.30.2020

Please see Prescribing Information, including Boxed Warning about lactic acidosis, and Medication Guide for JENTADUETO.
Please see Prescribing Information, including Boxed Warning about lactic acidosis, and Medication Guide for JENTADUETO XR.