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When using Kombiglyze XR, it is crucial to be aware of several important safety and warning considerations. Please review the following information and discuss any concerns with your healthcare provider:

• Lactic Acidosis: Kombiglyze XR contains metformin, which can rarely lead to lactic acidosis, a serious and potentially fatal condition. Symptoms to watch for include unusual tiredness, dizziness, severe drowsiness, chills, blue or cold skin, muscle pain, fast or difficult breathing, irregular heartbeat, and stomach pain accompanied by nausea, vomiting, or diarrhea. Seek immediate medical attention if these symptoms occur. This risk is heightened in individuals with kidney or liver disease, dehydration, heart failure, heavy alcohol use, or those undergoing surgery or certain medical procedures. Inform your doctor of any pre-existing conditions or medications.

• Heart Failure: The saxagliptin component of Kombiglyze XR has been associated with heart failure. Symptoms include shortness of breath, fluid retention, rapid weight gain, and increased fatigue. Consult your healthcare provider if you experience these symptoms, especially if you have a history of heart or kidney problems.

• Vitamin B12 Deficiency: Metformin may cause low vitamin B12 levels, potentially leading to anemia. Symptoms include persistent fatigue, muscle weakness, decreased appetite, and tingling in the hands or feet. Regular monitoring of B12 levels is recommended every 2-3 years, particularly for long-term users or those with reduced calcium or vitamin B12 absorption.

• Hypoglycemia (Low Blood Sugar): There is a risk of low blood sugar, particularly when Kombiglyze XR is combined with other diabetes medications. Symptoms include shakiness, rapid heartbeat, sweating, confusion, drowsiness, headache, vision changes, and extreme hunger. Discuss these risks with your provider, especially if you have dietary changes, consume alcohol, or have liver or kidney issues.

• Joint Pain: Severe joint pain has been reported with the use of saxagliptin. If you experience significant discomfort in your joints, contact your healthcare provider promptly.

• Pancreatitis: In rare cases, Kombiglyze XR can cause life-threatening pancreatitis. Alert your healthcare provider to severe stomach or back pain or vomiting. This risk is higher for individuals with alcoholism, high triglycerides, a history of pancreatitis, or gallstones.

• Bullous Pemphigoid: This medication may lead to the development of fluid-filled blisters on the skin. If you notice such blisters, seek medical advice as you may need to discontinue use and consult a dermatologist.

• Allergic Reactions: Some users may experience severe allergic reactions to saxagliptin, such as rash, hives, swelling of the face, tongue, or throat, and difficulty breathing. Immediate medical intervention is necessary if these occur.

Always inform your healthcare provider of your complete medical history and any other medications you are taking to ensure safe use of Kombiglyze XR.

Common side effects:

• Nausea
• Vomiting
• Diarrhea
• Headache
• Metallic taste in mouth

Less common but important to monitor:

• Low blood sugar
• High blood sugar
• Empty tablet shell in stool

Serious side effects:

• Lactic acidosis
• Severe allergic reactions
• Inflammation of the pancreas
• Heart failure
• Severe joint pain
• Skin reactions

Interactions with high risk of serious adverse effects and should be avoided:

• Azole antifungals (such as itraconazole, ketoconazole)
• Nefazodone
• Telithromycin
• Ritonavir

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Beta-blockers (such as metoprolol, propranolol, timolol)