Empagliflozin/Metformin Hydrochloride 12.5/1000 mg Tablet

Adult dose

The recommended dose of this medication is 1 tablet taken twice daily. The maximum recommended daily doses for each component should not exceed 25 mg for empagliflozin and 2000 mg for metformin. For patients whose blood sugar control is inadequate, a dose of 5 mg of empagliflozin taken twice daily (total daily dose of 10 mg) along with the existing dose of metformin is recommended. If tolerance is good, empagliflozin can be increased to between 10 mg and 25 mg.

This medication may cause a rare but serious side effect called lactic acidosis, so caution is warranted. When used in conjunction with other diabetes medications, hypoglycemia may occur, so caution is necessary. It should not be used in patients with significantly impaired kidney function, acute kidney issues, serious infections, heart failure, or other serious conditions. It is safe to avoid this medication in pregnant or breastfeeding women. Kidney function should be regularly monitored before and during treatment to assess condition. Caution is advised in situations of dehydration or where there is a risk of dehydration. This medication may increase the risk of urinary tract infections and genital infections, so consult a doctor immediately if symptoms of infection occur. In some patients, urination may increase, which should be noted. Long-term use may decrease vitamin B12 levels, so regular blood tests are necessary. Alcohol consumption may increase the risk of lactic acidosis, so excessive drinking should be avoided during use. This medication should be temporarily discontinued before and after surgery or tests using radiocontrast agents, and resumed only after confirming normal kidney function. Elderly patients are at higher risk for reduced kidney function, so dose adjustments and periodic monitoring are required. Any symptoms of hypoglycemia, lactic acidosis, or ketoacidosis during treatment should be reported to healthcare professionals immediately. This medication is not used in children as safety and efficacy have not been verified.

Serious side effects

Urticaria, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reaction, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attack, respiratory distress with coughing and fever, yellowing of skin or eyes (jaundice), profound malaise, liver abnormalities (jaundice), sudden

Mild side effects

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

This medication is sensitive to air and moisture, so it should be kept in a tightly sealed container. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius.

Appearance

A double-sided, convex, oval film-coated tablet with a dark brownish purplish color.

Package unit

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