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Empagliflozin/Metformin is an oral tablet that contains:

• 5 mg empagliflozin/500 mg metformin
• 5 mg empagliflozin/1,000 mg metformin
• 12.5 mg empagliflozin/500 mg metformin or
• 12.5 mg empagliflozin/1,000 mg metformin

Empagliflozin/Metformin is a SGLT2 inhibitor/biguanide combination that is used for the following:

• Type 2 diabetes
• Lowering the risk of death due to heart problems in adults with Type 2 diabetes and heart disease
• Lowering the risk of hospitalization and death due to heart problems in adults with Type 2 diabetes and heart failure

Empagliflozin/Metformin is a combination of two medications:
Empagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. It works in the kidneys to prevent sugar and sodium (salt) from absorbing back into your body. It lowers blood sugar by causing your body to get rid of excess sugar through your urine. By preventing sodium reabsorption, the heart fills with blood easier and pumps blood more easily throughout the body. Metformin is a biguanide. It lowers the amount of sugar that your liver makes. It also lowers the amount of sugar absorbed through the intestines. In addition, it makes your body more sensitive to a hormone called insulin. This means your cells are better able to take up sugar from the bloodstream and use it as energy.

• Your dose of Empagliflozin/Metformin will depend on your current medications — whether you’re currently taking either Jardiance (empagliflozin), metformin, or both
• Dosing for people who currently aren’t taking either Jardiance (empagliflozin) or metformin is listed below.
• Empagliflozin/Metformin
• Adults and children 10 years and older: The typical dose ranges from 5 mg/500 mg (empagliflozin / metformin) to 12.5 mg/1,000 mg (empagliflozin / metformin) by mouth twice daily with food. The maximum dose is 12.5 mg/1,000 mg (empagliflozin / metformin) twice daily.
• Empagliflozin/Metformin XR
• Adults only: The typical starting dose is 10 mg/1000 mg (empagliflozin / metformin) by mouth once daily in the morning with food. The maximum dose is 25 mg/2,000 mg (empagliflozin / metformin) once daily

Empagliflozin/Metformin is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication if you have any of the following:
Severe renal impairment (eGFR below 30 mL/min/1.73 m2), end stage renal disease, or on dialysis. Metabolic acidosis, including diabetic ketoacidosis. Hypersensitivity to empagliflozin, metformin or any of the excipients in Empagliflozin/Metformin or Empagliflozin/Metformin XR.

Common side effects of Empagliflozin/Metformin:

• Low blood sugar
• Urinary tract infections
• Upper respiratory tract infection or common cold symptoms (e.g., cough, runny nose)
• Vaginal yeast infection in females
• Genital fungal infections in males
• Joint pain
• Frequent urination
• Nausea
• Vomiting
• Diarrhea

Serious side effects are rare with Empagliflozin/Metformin. Contact your healthcare provider immediately if you experience any of the following.

• Buildup of lactic acid: confusion, feeling weak, fast heartbeat, rapid breathing, no appetite, nausea, vomiting
• Ketoacidosis (high ketone levels in the blood): shortness of breath, vomiting, belly pain, dry skin, dry mouth, feeling very tired, fruity-smelling breath
• Sudden kidney problems: urinating less than usual, chest pain
• Low blood pressure: dizziness, lightheadedness, confusion
• Serious genital infection: pain, swelling, or redness in the genital area; fever; weakness
  Severe allergic reactions: rash, blisters, sores, trouble breathing, swelling

The following medications may interact with Empagliflozin/Metformin:

• Carbonic Anhydrase Inhibitors: May increase risk of lactic acidosis
• Consider more frequent monitoring
• Drugs that Reduce Metformin Clearance: May increase risk of lactic acidosis. Consider benefits and risks of concomitant use
• See full prescribing information for additional drug interactions and information on interference of Empagliflozin/Metformin or Empagliflozin/Metformin XR with laboratory tests

Various FDA-approved generic manufacturers

Based on animal data showing adverse renal effects from empagliflozin, Empagliflozin/Metformin and Empagliflozin/Metformin XR are
not recommended during the second and third trimesters of pregnancy.

• Synjardy
• Synjardy XR