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This essential safety and warning information is intended to help you understand the potential risks and precautions associated with the use of Segluromet (ertugliflozin/metformin). Please review these points carefully and discuss any concerns with your healthcare provider.

• Lactic Acidosis Risk: In rare cases, Segluromet can lead to lactic acidosis due to lactic acid accumulation in the blood, which can be severe and life-threatening. Symptoms to watch for include feeling unwell, muscle pain, breathing difficulties, slow or irregular heartbeat, sleepiness, feeling cold, and stomach pain. Those at higher risk include older adults, individuals with kidney or liver issues, those undergoing surgery or using contrast dye, and individuals with heavy alcohol use or dehydration. Immediate medical attention is required if symptoms occur.

• Genital and Urinary Tract Infections: Segluromet may increase the risk of serious infections, including urinary tract infections, genital yeast infections, and a severe condition known as Fournier's gangrene. Symptoms to monitor include pain or burning during urination, frequent urination, fever, and genital area tenderness or swelling. Prompt medical evaluation is necessary if these symptoms develop.

• Low Blood Pressure: Fluid loss from Segluromet can result in low blood pressure, leading to dizziness, lightheadedness, tiredness, or blurred vision. Those with kidney issues, older adults, and those on diuretics are at increased risk. Report any symptoms to your healthcare provider.

• Ketoacidosis Risk: Although rare, ketoacidosis can occur, presenting with symptoms like severe dehydration, nausea, vomiting, stomach pain, tiredness, and shortness of breath. This condition requires immediate medical intervention, especially in those with high doses, reduced insulin doses, or alcohol abuse.

• Kidney Problems: Fluid loss can also cause kidney damage, particularly in individuals with low blood volume or existing kidney or heart problems. Monitoring kidney function is essential, and any changes in fluid intake or symptoms like reduced urine output, leg swelling, or nausea should be reported to your provider.

• Risk of Amputations: There is a potential increased risk of lower leg and foot amputations. Be vigilant for infections or sores in these areas, particularly if you have a history of circulation issues or previous amputations.

• Low Blood Sugar: Combining Segluromet with insulin or other medications that increase insulin levels can result in low blood sugar. Symptoms include headache, dizziness, confusion, and shakiness. Dose adjustments may be necessary to mitigate this risk.

• Low Vitamin B12 Levels: Segluromet may reduce vitamin B12 levels, which can usually be corrected with supplements or discontinuing the medication. Regular monitoring of B12 levels is advised.

Contraindications: Do not use Segluromet if you have severe kidney problems (eGFR less than 30 mL/min/1.73 m²), end-stage kidney disease, are on dialysis, or have metabolic acidosis, including diabetic ketoacidosis. Consult your healthcare provider if any of these conditions apply to you.

When using this medication, some individuals may experience common side effects such as diarrhea, nausea, vomiting, stomach gas, indigestion, weakness, headache, or more frequent urination. Additionally, genital yeast infections and urinary tract infections can occur. These effects are generally mild, but if they persist or worsen, consult your healthcare provider for guidance.

There are other side effects that may arise, including vaginal itching, symptoms resembling a common cold, back pain, weight loss, thirst, and an increase in low-density lipoprotein cholesterol (LDL-C). These are less common but should be discussed with your healthcare provider if experienced.

Serious side effects, though rare, should not be ignored and require immediate medical attention. These include lactic acidosis, which may present with symptoms like unusual muscle pain, difficulty breathing, or sleepiness; ketoacidosis, which involves severe dehydration and shortness of breath; and Fournier's gangrene, a serious infection of the genital area accompanied by fever or discomfort. Acute kidney injury, marked by low urine production and swelling, as well as severe dehydration, characterized by dizziness or lightheadedness, are critical and need urgent care.

Furthermore, this medication might increase the risk of lower limb amputation, particularly in individuals with existing foot problems or poor blood circulation. Regular foot checks are advised. While the medication rarely leads to low blood sugar (hypoglycemia), it can occur when combined with other diabetes treatments or during heavy exercise. Symptoms include sudden sweating, shaking, or dizziness. Stay hydrated to prevent dehydration, and seek medical advice if you experience severe allergic reactions or other unlisted side effects.