Empagliflozin/Metformin Tablet 12.5/500 mg (Empagliflozin, Metformin Hydrochloride)

Adult dose

The recommended dosage of this medication is 1 tablet taken twice a day. The dosage should not exceed the maximum daily recommended doses of empagliflozin 25 mg and metformin 2000 mg for each ingredient, considering each patient’s current treatment regimen, efficacy, and tolerability. The recommended dosage for patients who cannot achieve sufficient blood sugar control through monotherapy with metformin or in combination with other medications such as insulin is empagliflozin 5 mg taken twice a day (total daily dose 10 mg) and the existing dosage of metformin. If tolerated well with empagliflozin 10 mg (total daily dose), it can be increased to empagliflozin 25 mg (total daily dose) if additional blood sugar control is needed. Patients transitioning from a regimen of empagliflozin (total daily dose 10 mg or 25 mg) and metformin should start with their existing doses of empagliflozin and metformin. If this medication is taken in combination with sulfonylureas or insulin, a dosage reduction of sulfonylureas or insulin should be considered to decrease the risk of hypoglycemia (refer to precautions 4. and drug interactions 6.). This medication should be taken with meals to reduce gastrointestinal side effects related to metformin. If a dose is missed, take it as soon as you remember, but do not take double doses, and skip the missed dose. Special populations Patients with renal impairment No dose adjustment is needed for patients with mild renal impairment. Due to the presence of metformin, this medication can be used with dose adjustment in patients with an estimated glomerular filtration rate (eGFR) of 45-59 ml/min/1.73 m² or a creatinine clearance (CrCl) of 45-59 ml/min, provided they do not exhibit other symptoms that may increase the risk of lactic acidosis. In such patients, the initial dose of metformin should be 500 mg or 850 mg once daily, so treatment should be initiated with empagliflozin and metformin as separate agents. The maximum daily administration of metformin hydrochloride that can be given with this medication is 1000 mg, which can be taken as 500 mg twice a day. Renal function should be closely monitored every 3-6 months (refer to precautions, 3. Use with caution in the following patients). If CrCl < 45 ml/min or eGFR < 45 ml/min/1.73 m² occurs, this medication must be discontinued immediately (refer to precautions 2. Do not use in the following patients 2.). Elderly Patients aged 75 and older should consider the risk of decreased renal function and fluid volume.

This medication is used for the treatment of diabetes and helps in controlling blood sugar. However, this medication may cause rare complications such as severe lactic acidosis, so if symptoms like vomiting, abdominal pain, or difficulty breathing occur during treatment, you should consult a doctor immediately. Moreover, it is important to note that hypoglycemia may occur when this medication is taken along with other antidiabetic agents such as insulin or sulfonylureas. Patients with impaired renal function or those who have suffered acute kidney injury should not use this medication, as it may pose risks. Avoid using this medication during acute infections, severe dehydration, heart failure, or acute myocardial infarction. It is advisable for women who are pregnant or breastfeeding not to take this medication. Regular blood tests are recommended before and during treatment to monitor kidney function and blood creatinine levels, and extra caution should be taken in the elderly or in patients with decreased renal function. This medication may increase the risk of urinary tract infections and genital infections, so it is important to notify healthcare professionals immediately if infection symptoms appear. Additionally, this medication can reduce body fluid levels, leading to low blood pressure or dehydration, thus fluid status should be carefully monitored, especially in hypertensive patients or the elderly. It is advisable to avoid alcohol consumption during treatment, and temporarily discontinue use before and after sudden surgeries or examinations using iodine contrast agents. Be cautious as hypoglycemic symptoms may occur, particularly if meals are missed or excessive exercise is undertaken, and if hypoglycemic symptoms appear, appropriate actions should be taken immediately. Vitamin B12 levels may decrease, so regular blood tests are recommended for long-term use. Potential side effects of this medication include gastrointestinal disturbances such as nausea, vomiting, diarrhea, abdominal pain, headaches, dizziness, and in rare cases, rashes or allergic reactions may occur. If any abnormal symptoms occur during use, consult a doctor immediately and adhere to the prescribed dosage and administration guidelines.

Serious side effects

• Hives
• angioedema
• perineal necrosis
• ketoacidosis
• lactic acidosis
• urosepsis
• pyelonephritis
• cerebral infarction
• myocardial infarction
• acute kidney injury

Mild side effects

• Hypoglycemia
• urinary tract infections
• genital infections
• increased urination
• nausea
• vomiting
• diarrhea
• abdominal pain
• loss of appetite
• constipation

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture and should be kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the efficacy of the medication.

Appearance

Light brownish-purple, double convex, oval, film-coated tablet

Package unit

60 tablets/box[10 tablets/PTP × 6], 10 tablets/box[10 tablets/PTP × 1], 60 tablets/bottle, 30 tablets/bottle