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This document outlines important safety and warning information regarding the use of Synjardy. It's crucial that you review these details and discuss any concerns with your healthcare provider.

• Lactic Acidosis Risk: Metformin, a component of Synjardy, can lead to a rare but severe condition known as lactic acidosis. This is especially a risk for individuals who are older, have kidney or liver issues, suffer from heart failure, are dehydrated, consume heavy amounts of alcohol, or undergo surgery or imaging procedures that use contrast dye. Immediate medical attention is necessary if symptoms such as unusual fatigue, dizziness, severe drowsiness, chills, blue/cold skin, muscle pain, breathing difficulties, irregular heartbeat, or abdominal pain with nausea/vomiting/diarrhea occur.

• Diabetic Ketoacidosis (DKA): Empagliflozin, another key ingredient in Synjardy, can cause diabetic ketoacidosis. This condition arises when the body lacks insulin to utilize blood sugar for energy, leading to excessive production of acidic ketones. Factors increasing risk include prolonged fasting, surgery, sudden fever, pancreatic problems, changes in insulin dosage, and excessive alcohol consumption.

• Dehydration and Kidney Concerns: Synjardy may result in decreased fluid levels, potentially causing dehydration, low blood pressure, or acute kidney injury. Those aged 65 and older, individuals with a history of kidney problems, users of certain diuretics, or those on a low-sodium diet are at heightened risk.

• Genital and Urinary Infections: There is an elevated risk for genital and urinary tract infections when taking Synjardy, particularly in individuals with a history of such infections. In rare cases, these infections might become severe and necessitate hospitalization or surgery.

• Vitamin B12 Deficiency: Long-term use of Synjardy can reduce vitamin B12 levels, potentially leading to anemia. Regular monitoring and supplementation may be required, especially if symptoms like low energy, dizziness, muscle issues, or tingling in the extremities are experienced.

• Amputation Risk: There is a rare possibility of leg or foot amputations, particularly in those with peripheral artery disease, diabetic foot ulcers, or a history of amputation.

• Severe Allergic Reactions: Synjardy can trigger severe allergic reactions, including rash, swelling, difficulty breathing, and dizziness. Discontinue use and seek immediate medical care if these symptoms occur. Those with a history of allergies to metformin or SGLT2 inhibitors should exercise caution.

• Hypoglycemia Hazard: When used with other diabetes medications, Synjardy can cause low blood sugar, especially in children over 10 years old or when insulin levels are raised. It's vital to recognize hypoglycemia symptoms and have quick-acting carbohydrates available for treatment.

Contraindications: Synjardy is not recommended for individuals with severe kidney issues, including those on dialysis, those experiencing acute or chronic acidosis, or those with a history of allergic reactions to its active ingredients, empagliflozin, or metformin.

In case of overdose or severe side effects, seek emergency medical assistance promptly. Always consult your healthcare provider for personalized advice and before making any changes to your medication regimen.

When taking this medication, you may encounter some common side effects such as headache, diarrhea, nausea, vomiting, and symptoms resembling a common cold, such as a runny nose or sore throat. These are usually mild and should subside over time. However, if they persist or worsen, it's important to inform your healthcare provider.

Some users may experience low blood sugar, with symptoms like sudden sweating, shaking, or a fast heartbeat. It's advisable to have a quick source of sugar at hand, such as glucose tablets, to address this swiftly. Urinary tract infections and increased urination can also occur, as well as vaginal yeast infections in females and genital fungal infections in males. Joint pain, excessive gas, belly discomfort, indigestion, and lack of energy are other potential side effects.

Rare but serious side effects require immediate medical attention. These include lactic acidosis, characterized by confusion, rapid breathing, or feeling weak; ketoacidosis, marked by shortness of breath and fruity-smelling breath; sudden kidney problems, which might present as reduced urination; and low blood pressure, resulting in dizziness or lightheadedness. A severe genital infection, known as Fournier's gangrene, may cause pain, swelling, or redness in the genital area, accompanied by fever or a general feeling of being unwell. In very rare cases, severe allergic reactions can occur, with symptoms like rash, severe dizziness, or trouble breathing.

To minimize the risk of dehydration and potential kidney damage, ensure you stay well-hydrated, especially if you experience vomiting or diarrhea. Be vigilant about any changes in your condition and consult your healthcare provider if any symptoms arise or persist.