Empagreen Duo Tablet 5/850mg

Adult dose

The recommended dosage of this medication is 1 tablet taken twice daily. For patients unable to achieve sufficient blood sugar control with metformin alone or in combination with insulin or other medications, the recommended dosage is 5 mg of empagliflozin taken twice daily (total daily amount of 10 mg) along with the existing metformin dosage. If a patient demonstrates good tolerability to 10 mg of empagliflozin (total daily amount) and requires additional blood sugar control, the dose may be increased to 25 mg (total daily amount). Patients switching to this medication from a regimen of empagliflozin (total daily amount of 10 mg or 25 mg) and metformin should be administered based on the current doses of empagliflozin and metformin. When taken in conjunction with sulfonylureas or insulin, it may be advisable to reduce the doses of sulfonylureas or insulin to minimize the risk of hypoglycemia (refer to precaution 4. adverse reactions and 6. interactions). This medication should be taken with meals to reduce gastrointestinal side effects related to metformin. If a dose is forgotten, take it as soon as remembered. However, do not take a double dose at once; in such cases, the missed dose should be skipped. Special Groups Renal Impairment Dose adjustment is not necessary for patients with mild renal impairment. Due to the presence of metformin, patients with an estimated glomerular filtration rate (eGFR) of 45-59 ml/min/1.73m2, or creatinine clearance (CrCl) of 45-59 ml/min may use it with caution if they do not exhibit other symptoms that increase the risk of lactic acidosis. The initial dosage of metformin for such patients is 500 mg or 850 mg once daily, so treatment should commence with individual single doses of empagliflozin and metformin. The maximum daily dose of metformin hydrochloride that can be administered with this medication is 1000 mg, which may be dosed as 500 mg twice daily. Renal function should be carefully monitored every 3-6 months (refer to precaution, section 3. use cautiously in the following patients, item 1). If CrCl < 45 ml/min or eGFR < 45 ml/min/1.73m2 indicates declining renal function, this medication should be discontinued immediately (refer to precaution 2. do not administer to the following patients, item 2). Elderly Patients over 75 years of age should consider the risks of reduced kidney function and fluid volume.

This medication contains metformin and empagliflozin, which help with blood sugar control. When taking this medication, there is a risk of rare side effects such as severe lactic acidosis, so caution is required for patients with impaired kidney function or liver dysfunction. Moreover, when taken together with insulin or sulfonylurea medications, there may be an increased risk of hypoglycemia, so blood sugar levels should be closely monitored. Patients with moderate to severe renal impairment or acute infections, heart failure, or acute myocardial infarction should not take this medication. This medication should be temporarily discontinued before and after tests using iodine contrast media, and resuming medication should only occur once kidney function is confirmed to be normal after the examination. Patients at risk of decreased fluid volume, such as those experiencing dehydration, vomiting, or diarrhea, require additional caution when taking this medication. This medication may increase the risk of genital infections and urinary tract infections, so patients should consult medical personnel immediately if infection symptoms occur. Vitamin B12 levels may decrease, so it is recommended to regularly check vitamin B12 concentrations during long-term use. Women who are pregnant or may become pregnant, and nursing mothers should not take this medication; particularly, it is recommended to refrain from breastfeeding while on this medication. Elderly individuals commonly experience impaired kidney function, so regular kidney function checks and starting at the minimum dosage is advisable when taking this medication. In cases of overdose, serious side effects such as lactic acidosis may occur, so it is essential to adhere to prescribed dosages, and seek immediate medical attention if side effects arise. This medication has not yet been established for safety and efficacy in children, so it is not recommended for individuals under 18 years of age. Finally, while on this medication, it is important to continuously monitor blood sugar levels and physical condition, and notify medical personnel immediately if unusual symptoms occur.

Serious side effects

• Hives
• angioedema
• perineal necrosis
• ketoacidosis
• lactic acidosis
• pyelonephritis
• urosepsis
• acute kidney injury
• acute cholecystitis
• autoimmune hepatitis

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 or moisture. It is recommended to maintain room temperature between 1 to 30 degrees Celsius.

Appearance

Yellowish white, bilaterally convex, oval film-coated tablet

Package unit

10 tablets/box [(10 tablets/PTP x 1)], 60 tablets/box [(10 tablets/PTP x 6)], 60 tablets/bottle