Linagliptin

What it is used for

JENTADUETO XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JENTADUETO XR is a combination of linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of Use Not recommended in patients with type 1 diabetes mellitus Has not been studied in patients with a history of pancreatitis Limitations of Use JENTADUETO XR is not recommended in patients with type 1 diabetes mellitus.

JENTADUETO XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO XR.

The most important thing to know

TRADJENTA can cause serious side effects, including: Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis. Before you start taking TRADJENTA, tell your healthcare provider if you have ever had: inflammation of your pancreas (pancreatitis) a history of alcoholism stones in your gallbladder (gallstones) high blood triglyceride levels Stop taking TRADJENTA and call your healthcare provider 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 to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis. What is TRADJENTA? TRADJENTA is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes mellitus. TRADJENTA is not for people with type 1 diabetes mellitus.

If you have had pancreatitis in the past, it is not known if you have a higher chance of getting pancreatitis while you take TRADJENTA. It is not known if TRADJENTA is safe and effective in children.

How to take it

Take TRADJENTA exactly as your healthcare provider tells you to take it. Take 1 tablet 1 time each day with or without food. If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take two doses of TRADJENTA at the same time.

Your healthcare provider may tell you to take TRADJENTA along with other diabetes medicines. Low blood sugar can happen more often when TRADJENTA is taken with certain other diabetes medicines. See "

Side effects, and when to stop

" If you take too much TRADJENTA, call your healthcare provider or local poison control center or go to the nearest hospital emergency room right away. What are the possible side effects of TRADJENTA? TRADJENTA may cause serious side effects, including: Low blood sugar (hypoglycemia). If you take TRADJENTA with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher.

The dose of your sulfonylurea medicine or insulin may need to be lowered while you take TRADJENTA. Signs and symptoms of low blood sugar may include: headache irritability drowsiness hunger weakness fast heartbeat dizziness sweating confusion shaking or feeling jittery Allergic (hypersensitivity) reactions. Serious allergic reactions have happened in people who are taking TRADJENTA.

Symptoms may include: swelling of your face, lips, tongue, throat, and other areas on your skin raised, red areas on your skin (hives) difficulty with swallowing or breathing skin rash, itching, flaking, or peeling If you have any of these symptoms, stop taking TRADJENTA and call your healthcare provider right away or go to the nearest hospital emergency room.

Joint pain. Some people who take TRADJENTA, may develop joint pain that can be severe. Call your healthcare provider if you have severe joint pain. Skin reaction. Some people who take medicines called DPP-4 inhibitors like TRADJENTA, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital.

Tell your healthcare provider right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your healthcare provider may tell you to stop taking TRADJENTA. Heart failure. Heart failure means your heart does not pump blood well enough. Before you start taking TRADJENTA, tell your healthcare provider if you have ever had heart failure or have problems with your kidneys.

Contact your healthcare provider 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 unusual tiredness These may be symptoms of heart failure.

The most common side effects of TRADJENTA include: stuffy or runny nose and sore throat cough diarrhea Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TRADJENTA. For more information, ask your healthcare provider or pharmacist.

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

Who should not take it

Do not take TRADJENTA if you: are allergic to linagliptin or any of the ingredients in TRADJENTA. See the end of this Medication Guide for a complete list of ingredients in TRADJENTA. Symptoms of a serious allergic reaction to TRADJENTA may include: skin rash, itching, flaking or peeling raised red patches on your skin (hives) swelling of your face, lips, tongue and throat that may cause difficulty in breathing or swallowing difficulty with swallowing or breathing If you have any of these symptoms, stop taking TRADJENTA and call your healthcare provider right away or go to the nearest hospital emergency room.

What to say before you start

Before taking TRADJENTA, tell your healthcare provider about all of your medical conditions, including if you: have or have had inflammation of your pancreas (pancreatitis). are pregnant or plan to become pregnant. It is not known if TRADJENTA will harm your unborn baby. If you are pregnant, talk with your healthcare provider about the best way to control your blood sugar while you are pregnant.

are breastfeeding or plan to breastfeed. It is not known if TRADJENTA passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you take TRADJENTA. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

TRADJENTA may affect the way other medicines work, and other medicines may affect how TRADJENTA works. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Storing it

Store TRADJENTA at room temperature between 68°F and 77°F (20°C and 25°C). Keep TRADJENTA and all medicines out of the reach of children.