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Jentadueto XR is the brand name for linagliptin and metformin hydrochloride and is available as an extended-release oral tablet.

Jentadueto XR is available as an extended-release oral tablet that contains:

• 5 mg linagliptin/1,000 mg metformin HCl or 2.5 mg linagliptin/1,000 mg metformin HCl

• Jentadueto XR is a DPP-4 inhibitor / Biguanide and is used to treat type 2 diabetes in adults.

Jentadueto XR is a combination of two medications. Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. It works by blocking DPP-4, a protein that breaks down certain hormones in your body. These hormones normally tell your body to make more insulin and produce less sugar. When DPP-4 causes these hormone levels to drop, you end up having high blood sugar levels. By blocking the action of DPP-4, linagliptin helps your body produce more insulin and make less sugar. In doing so, linagliptin helps lower your blood sugar levels. Metformin is a biguanide that lowers blood sugar in several ways. It lowers the amount of sugar that your liver makes. It also makes your body more sensitive to the effects of insulin. When your body is able to use insulin better, it can move more blood sugar into your cells to use as energy. In addition, metformin lowers the amount of sugar that gets absorbed through your intestines. As a result of these three pathways, metformin helps lower the amount of sugar in your bloodstream.

• Jentadueto XR is typically started at 5 mg/1000 mg (linagliptin / metformin) by mouth once daily with food. The maximum dose is 5 mg/2000 mg (linagliptin / metformin) once daily.

Jentadueto XR is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication if you have:

• Severe renal impairment (eGFR below 30 mL/min/1.73 m2)
• Metabolic acidosis, including diabetic ketoacidosis.
  Hypersensitivity to linagliptin, metformin, or any of the excipients in Jentadueto XR

Common side effects of Jentadueto XR:

• Cough, runny or stuffy nose, and other symptoms of an upper respiratory tract infection
• Diarrhea

Serious side effects are rare with Jentadueto XR. Contact your healthcare provider immediately if you experience any of the following.

• Buildup of lactic acid: confusion, feeling weak, fast or slow heartbeat, rapid breathing, no appetite, nausea, vomiting
• Inflamed pancreas: upper stomach pain, fever, nausea, vomiting
• Severe skin or allergic reactions: rash, blisters, sores, trouble breathing, swelling

The following medications may interact with Jentadueto XR:

• Carbonic Anhydrase Inhibitors: May increase risk of lactic acidosis
• Consider more frequent monitoring
• Drugs that Reduce Metformin Clearance: May increase risk of lactic acidosis. Consider benefits and risks of concomitant use
• Alcohol: Can potentiate the effect of metformin on lactate metabolism
• Warn patients against excessive alcohol intake
• Strong P-glycoprotein/CYP3A4 Inducer: Efficacy may be reduced when administered in combination (e.g., rifampin). Use of alternative treatments is strongly recommended

Boehringer Ingelheim Pharmaceuticals, Inc.

It is not known if Jentadueto XR will harm your unborn baby. If you become pregnant while receiving Jentadueto XR, talk to your healthcare provider.

• Linagliptin/Metformin