Jentadueto contains a combination of linagliptin and metformin. 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.

Jentadueto is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Jentadueto is not for treating type 1 diabetes.

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

There may be an increased risk of developing 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.

Before you take Jentadueto, tell your doctor if you have liver disease, a serious infection, heart disease, a history of pancreatitis, if you have recently had a heart attack, or if you are over 65 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 may need to temporarily stop taking Jentadueto.

You may develop lactic acidosis. Get emergency medical help if you have unusual muscle pain, trouble breathing, irregular heartbeats, dizziness, vomiting, or if you feel cold, tired, or very weak.

Take Jentadueto exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take Jentadueto with a meal, unless your doctor tells you otherwise.

Swallow the tablet whole and do not crush, chew, or break it.

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.

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

Store at room temperature away from moisture and heat.

Usual Adult Dose for Diabetes Type 2:

Linagliptin-metformin immediate release tablets:
-Initial dose for patients currently not receiving metformin: linagliptin 2.5 mg/metformin 500 mg orally twice a day
-Initial dose for patients currently receiving metformin: linagliptin 2.5 mg in combination with one-half of current metformin dose orally twice a day
-Initial dose for patients currently receiving linagliptin and metformin as individual components: switch to combination product containing the same doses of each component orally twice a day
Maintenance dose: Individualize dose based on safety and efficacy
Maximum dose: linagliptin 5 mg/day; metformin 2000 mg/day

Linagliptin-metformin extended-release tablets:
-Initial dose for patients currently not receiving metformin: linagliptin 5 mg/metformin extended-release 1000 mg orally once a day
-Initial dose for patients currently receiving metformin: linagliptin 5 mg in combination with a similar total daily dose of metformin orally once a day
-Initial dose for patients currently receiving linagliptin and metformin as individual components: switch to combination product containing similar doses of each component orally once a day
Maintenance dose: Individualize dose based on safety and efficacy
Maximum dose: linagliptin 5 mg/day; metformin 2000 mg/day

Comments:
-Patients taking two linagliptin 2.5 mg/metformin 1000 mg extended-release tablets should take the 2 tablets together once a day.
-When used in combination with insulin or an insulin secretagogue, a lower dose of insulin or the insulin secretagogue may be necessary to reduce the risk of hypoglycemia.

Use: To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise when treatment with both linagliptin and metformin are appropriate.

You should not use Jentadueto if you are allergic to linagliptin (Tradjenta) or metformin, or if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment with insulin).

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

• kidney disease;

• heart disease;

• liver disease;

• pancreatitis;

• gallstones;

• alcoholism; or

• high triglycerides (a type of fat in the blood).

You may develop lactic acidosis. 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.

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 Jentadueto. Be sure your caregivers know ahead of time that you are using this medication.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor's instructions about using Jentadueto 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.

Jentadueto may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

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

Take the medicine (with food) 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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have severely low blood sugar (extreme weakness, nausea, tremors, sweating, confusion, trouble speaking, fast heartbeats, or seizure).

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 to Jentadueto: (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

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.

Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, fast/slow or irregular heartbeats, dizziness, feeling cold, or feeling very weak or tired.

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; or

• symptoms of heart failure - shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain.

Common Jentadueto side effects 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.

Many drugs can interact with linagliptin and metformin, making this medicine less effective or increasing your risk of lactic acidosis. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.