Empagliflozin/Metformin Hydrochloride Tablets 12.5/1000 mg

Adult dose

The recommended dosage of this medication is 1 tablet, twice a day. The dosage should be determined based on the patient's treatment regimen, efficacy, and tolerability, without exceeding 25 mg of empagliflozin and 2000 mg of metformin. If blood glucose control is insufficient, it is recommended to take 5 mg of empagliflozin twice daily (total 10 mg) with the existing dose of metformin. If tolerability is excellent, it can be increased from 10 mg to 25 mg of empagliflozin.

This medication can cause a rare but serious side effect known as severe lactic acidosis, so regular checks on kidney function should be conducted to prevent this. Caution is needed as this medication may cause hypoglycemia when taken with other antidiabetic medications like insulin or sulfonylureas. Patients with moderate to severe renal impairment, acute kidney issues, severe infections, or heart failure should not take this medication. Patients undergoing examinations using iodine contrast agents should stop this medication 48 hours prior to the examination and resume only after confirming normal kidney function. It is safest for pregnant or breastfeeding women not to take this medication, and women who may become pregnant should also avoid it. This medication may cause side effects such as increased urination, urinary tract infections, and genital infections; if any abnormal symptoms appear, consult a doctor immediately. Especially elderly patients or those at risk of dehydration should be cautious as hypotension or dizziness may occur due to fluid loss. Regular blood tests to monitor kidney function and vitamin B12 levels during medication is essential. No special effects have been reported during driving or operating machinery, but caution is advised for symptoms of hypoglycemia or dizziness. In case of overdose, visit a hospital immediately for appropriate treatment, as rapid medical intervention is necessary due to the risk of lactic acidosis.

Serious side effects

• Hives
• angioedema
• perineal necrosis
• lactic acidosis
• ketoacidosis
• urinary sepsis
• pyelonephritis
• severe rash with fever
• blisters
• skin peeling

Mild side effects

• Nausea
• vomiting
• diarrhea
• abdominal pain
• loss of appetite
• constipation
• altered taste
• itching
• rash
• hives

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 to 30 degrees Celsius.

Appearance

A biconvex, oval film-coated tablet with a dark brownish purple color.

Package unit

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