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This document outlines critical safety information and warnings associated with the use of Jentadueto (linagliptin/metformin), an antidiabetic medication. It is essential to review these details carefully and discuss any concerns with your healthcare provider to ensure safe use of the medication.

• Lactic Acidosis Risk: Rarely, metformin can lead to a serious condition known as lactic acidosis, characterized by an excessive build-up of lactic acid in the blood. This condition can be life-threatening if untreated and may result in organ failure. Individuals with kidney or liver issues, heart failure, those who are 65 years or older, who consume excessive alcohol, or are undergoing procedures with contrast dye are at higher risk. If you experience symptoms such as difficulty breathing, irregular heartbeat, muscle pain, severe fatigue, dizziness, or stomach pain with nausea or vomiting, seek immediate medical assistance.

• Pancreatitis Risk: Although uncommon, linagliptin has been linked to inflammation of the pancreas. Symptoms to watch for include upper abdominal pain, fever, nausea, and vomiting. If these occur, contact your healthcare provider promptly, as discontinuation of the medication might be necessary.

• Heart Failure Warning: Inform your healthcare provider if you have a history of heart or kidney problems before starting Jentadueto. Though rare, similar medications have been associated with heart failure. Symptoms such as difficulty breathing, fatigue, swelling, or sudden weight gain should be reported immediately, as they may require hospitalization and stopping the medication.

• Allergic Reactions: Jentadueto may cause severe allergic reactions, especially if you have a history of allergies to DPP-4 inhibitors. Symptoms include rash, skin peeling, swelling, breathing difficulties, and dizziness. Discontinue use and seek medical help if these occur.

• Vitamin B12 Deficiency: Long-term use of metformin can result in lowered vitamin B12 levels, increasing the risk of anemia. Regular monitoring of vitamin B12 levels is recommended, and supplementation may be advised if needed. Report symptoms like fatigue, dizziness, muscle issues, or tingling in extremities to your provider.

• Joint Pain: Some individuals may experience severe joint pain while taking medications similar to linagliptin. If joint discomfort arises, consult your provider, as discontinuation might be necessary.

• Severe Skin Reactions: Jentadueto has been associated with an itchy, blistering rash known as bullous pemphigoid. Discontinue the medication and consult your provider if you develop these skin symptoms.

Contraindications: Do not use Jentadueto if you have severe kidney problems, any form of serious acidosis, or a history of allergic reaction to linagliptin or metformin. Always discuss your complete medical history with your healthcare provider to ensure the safe use of this medication.

When taking this medication, you may experience some common side effects such as nausea, vomiting, diarrhea, stomach upset, and symptoms of an upper respiratory tract infection like a runny or stuffy nose. These effects are usually mild and often resolve on their own. However, if they persist or worsen, it's important to consult your healthcare provider for advice. You might also notice an empty tablet shell in your stool, which is harmless as the medication has already been absorbed by your body.

Some users report other side effects including passing gas, weakness, stomach discomfort, and headaches. If you experience these, it's advisable to monitor their intensity and consult your doctor if they become bothersome.

There are also rare but serious side effects that require immediate medical attention. These include signs of lactic acidosis, such as confusion, feeling weak, a fast or slow heartbeat, rapid breathing, or a lack of appetite. Symptoms of an inflamed pancreas, like upper stomach pain, fever, or persistent nausea and vomiting, are also critical. Additionally, severe allergic reactions such as rash, blisters, trouble breathing, or swelling, especially of the face, tongue, or throat, demand urgent care.

It's essential to recognize symptoms of low blood sugar, which may occur if this drug is combined with other anti-diabetic medications, or if you skip meals or engage in heavy exercise. These symptoms include sudden sweating, shaking, a fast heartbeat, hunger, blurred vision, dizziness, or tingling in the hands and feet. To address low blood sugar quickly, consider carrying glucose tablets or consuming a fast-acting sugar source like candy or fruit juice. Conversely, signs of high blood sugar, such as increased thirst and urination, should also be reported to your doctor, as they may require adjustments to your treatment plan.

This summary covers a range of potential side effects, but it's not exhaustive. Always communicate with your healthcare provider about any new or concerning symptoms you might experience.

When taking Jentadueto, which contains linagliptin and metformin, it's important to be aware of potential interactions with other medications. Beta-blockers, such as metoprolol, propranolol, and timolol (used in glaucoma eye drops), can mask the symptoms of low blood sugar, like a rapid heartbeat. However, they do not affect other signs of low blood sugar, such as dizziness, hunger, or sweating. Additionally, many medications can influence blood sugar control, so it is crucial to consult your doctor or pharmacist before making any changes to your medication regimen. Regularly monitor your blood sugar as advised by your healthcare provider and report any symptoms of high or low blood sugar. Your treatment plan, including medication, exercise, or diet, might need adjustments based on these results.

Furthermore, some medications can alter how linagliptin is eliminated from the body, impacting its effectiveness. For example, rifampin is known to affect linagliptin's removal. Using Jentadueto with certain medications, such as various iodinated contrast agents, aspirin, and some antibiotics, might not be recommended or may require dose adjustments due to potential interactions. It's essential to inform your healthcare team about all other medications you are taking, including over-the-counter drugs and supplements, to manage potential risks effectively.