Empagliflozin/Metformin Tablets 12.5/850 mg

Adult dose

The recommended dosage of this medication is 1 tablet once, twice daily. The dosage should be determined considering the current treatment regimen, efficacy, and tolerability of the patient without exceeding the maximum recommended daily doses of empagliflozin 25 mg and metformin 2000 mg. When glycemic control is inadequate with monotherapy of metformin or in combination with other medications like insulin, the recommended dosage is empagliflozin 5 mg twice daily for a total of 10 mg per day, along with the existing metformin dosage.

This medication is an antidiabetic agent that helps lower blood sugar. It may cause a rare side effect known as lactic acidosis, which can lead to a dangerous condition due to excessive lactate build-up in the body, so caution is advised. There is a risk of hypoglycemia when taken with insulin or other antidiabetic medications, so blood glucose levels should be monitored closely. Patients with severely impaired renal function, certain acute illnesses, Type 1 diabetes, or women who are pregnant or breastfeeding should not take this medication. Prior to and after examinations using iodinated contrast agents, this medication should be temporarily discontinued to prevent risks of worsening renal function and lactic acidosis. Regular kidney function tests should be performed during the use of this medication, and it should be suspended or used carefully before and after dehydration, severe infections, or surgery. This medication can increase urination and may elevate the risk of urinary tract infections or genital infections, so consult a doctor if symptoms appear. Additionally, various side effects such as gastrointestinal disturbances, hypoglycemia, liver function abnormalities, skin rashes, etc., may occur; any unusual symptoms should be reported. Elderly patients or those at risk of fluid loss should take special care. Alcohol consumption may increase the risk of lactic acidosis, so it should be avoided. Women who are pregnant, may become pregnant, or are breastfeeding are advised not to use this medication. In case of overdose, hemodialysis might be necessary; thus, adherence to the prescribed dose and the doctor's instructions is crucial. The safety and efficacy of this medication in children have not been established, and it is not recommended for individuals under 18 years of age. Regular blood tests and kidney function tests should be conducted during the course of this medication, with attention paid to signs of hypoglycemia or infection. Caution is needed when driving or operating machinery during the use of this medication, depending on symptoms.

Serious side effects

• Urticaria
• angioedema
• perineal necrosis
• ketoacidosis
• lactic acidosis
• urosepsis
• pyelonephritis
• severe allergic reactions
• severe skin reactions
• difficulty breathing

Mild side effects

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

Store this medication in a tightly closed container to protect from air and moisture. It is advisable to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance

Pink-tinged white, biconvex oval film-coated tablets

Package unit

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