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The safety and warning information provided here is crucial for anyone considering or currently using Glyxambi (empagliflozin / linagliptin). Consult your healthcare provider if you have any questions or concerns.

• Pancreas Issues: Although uncommon, some patients have experienced pancreatitis (inflammation of the pancreas) while using linagliptin. Symptoms to watch for include upper abdominal pain, fever, nausea, and vomiting. If these occur, contact your healthcare provider immediately as you may need to discontinue the medication.

• Ketoacidosis Risk: Diabetic ketoacidosis (DKA) can occur, especially in Type 2 diabetes patients with pancreatic issues. This condition involves excessive acid in the blood and is more likely if blood sugar levels become dangerously high. Triggers include fasting, surgery, fever, pancreatic issues, reduced insulin doses, and excessive alcohol intake.

• Dehydration and Kidney Concerns: Empagliflozin can increase urination, leading to dehydration, low blood pressure, or acute kidney injury, sometimes necessitating hospitalization or dialysis. Risk factors include older age, existing kidney issues, diuretics use, and low-sodium diets. Monitor for symptoms like dizziness, confusion, chest pain, or reduced urination and consult your healthcare provider if they occur.

• Low Blood Sugar: Combining Glyxambi with insulin or sulfonylureas may cause hypoglycemia. Symptoms include shakiness, confusion, or irritability. Keep glucose tablets or another rapid sugar source on hand to manage low blood sugar episodes.

• Infections: There is a heightened risk of genital and urinary tract infections, including kidney infections and yeast infections. Past occurrences increase your risk. Severe cases may require hospitalization. Seek immediate medical attention if you experience symptoms such as genital itching, painful urination, cloudy urine, or back pain.

• Allergic Reactions: Serious allergic reactions, including skin rash, swelling, or breathing difficulties, can occur, particularly within the first three months. Individuals with a history of reactions to DPP-4 inhibitors should exercise caution.

• Joint Pain: Severe joint pain may occur at any time during treatment. Most cases resolve upon discontinuation. Report any joint discomfort to your healthcare provider.

• Amputation Risk: Although rare, some patients have required foot or leg amputations. Those with a history of amputations, peripheral artery disease, or diabetic foot ulcers should be particularly cautious.

• Heart Failure: If you have a history of heart or kidney problems, inform your healthcare provider before starting Glyxambi. Some studies suggest a possible increased risk for heart failure. Report symptoms such as difficulty breathing, fatigue, swelling, or sudden weight gain.

Contraindications: Glyxambi should not be used by individuals undergoing dialysis as it may pose serious health risks. Always consult your healthcare provider if this applies to you.

Taking this medication may lead to increased urination, dizziness, or lightheadedness, which are generally mild and manageable. To prevent dizziness, rise slowly from sitting or lying positions. If these effects persist or worsen, consult your healthcare provider. More serious side effects, though rare, need immediate attention. These include symptoms of a urinary tract infection, such as burning or painful urination, as well as potential signs of kidney issues like a change in urination frequency, joint pain, or unusual skin blisters.

There is a risk of developing a yeast infection in the genital area, characterized by unusual discharge or itching. Additionally, this medication might increase the risk of a rare but serious bacterial infection in the genital or anal area, known as Fournier's gangrene, which requires urgent medical care if accompanied by fever and feelings of unwellness. Another serious concern is the increased risk of lower limb amputation, particularly if you have existing foot ulcers or poor blood flow.

Low blood sugar may occur, especially if combined with other diabetes medications or irregular eating habits. Symptoms include sudden sweating, shaking, and fast heartbeat. In contrast, symptoms of high blood sugar, such as increased thirst and urination, should also be reported. This medication can also lead to dehydration, potentially causing severe kidney damage; therefore, maintaining adequate fluid intake is crucial.

Severe side effects that demand prompt medical intervention include signs of inflamed pancreas, like persistent nausea and abdominal pain, or symptoms of ketoacidosis, such as shortness of breath and fruity-smelling breath. Sudden kidney problems, evidenced by decreased urination, and serious allergic reactions, including rash and difficulty breathing, also require immediate medical care. While most people do not experience severe side effects, it is important to be aware and seek assistance if necessary.

Some medications can influence how linagliptin is removed from your body, potentially altering its effectiveness. For example, rifampin may have this effect. Additionally, beta blockers, including medications like metoprolol, propranolol, and timolol (often found in glaucoma eye drops), can mask the sensation of a rapid or pounding heartbeat when your blood sugar drops too low. However, other low blood sugar symptoms, such as dizziness, hunger, or sweating, remain unaffected by these drugs.

Various medications can impact your blood sugar levels, complicating their management. It is important to consult your doctor or pharmacist before starting, stopping, or changing any medication, as they can advise on potential effects on your blood sugar. Regular monitoring of your blood sugar is crucial, and you should report any high or low blood sugar symptoms to your doctor immediately. Your doctor may need to adjust your diabetes regimen, which could include changes to your medication, exercise, or diet.

It's also important to note that linagliptin may interfere with some laboratory tests, such as urine glucose tests, possibly leading to incorrect results. Be sure to inform lab staff and all your healthcare providers that you are taking this medication.