Kwangdong Empaglo Tablet 25 mg (Empagliflozin)

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and additional combination therapy with insulin and other hypoglycemic agents. If 10 mg of this medication is tolerated well and additional blood sugar control is needed, the dose may be increased to 25 mg once daily. This medication can be administered without regard to meals. The tablet should be swallowed whole. If a dose is missed, take it as soon as remembered.

This medication should not be used in certain patients. First, it should not be administered to patients with known allergies to its components. Second, it is not for use in patients with type 1 diabetes or diabetic ketoacidosis. Third, it should not be given to patients with severely impaired renal function, end-stage renal disease, or those on dialysis. Fourth, since this medication contains lactose, patients with lactose intolerance or galactose metabolism disorders should avoid it. When using this medication, caution is especially advised in patients with reduced renal function. If renal function falls below a certain level, the dose of this medication should be reduced or use should be discontinued. It is not expected to be effective in patients with end-stage renal disease or those on dialysis. It should be used cautiously in patients with mild heart failure, and is not recommended for patients with severe heart failure. The risk of hypoglycemia may increase when used in combination with other hypoglycemic agents like insulin or sulfonylureas, so dosage adjustments of these medications may be necessary. Side effects such as hypoglycemia, genital infections, urinary tract infections, increased urination, decreased fluid volume, liver function abnormalities, etc., may occur during treatment; therefore, attention to symptoms is crucial. Particularly, serious metabolic disturbances such as ketoacidosis may occur, so if symptoms like vomiting, abdominal pain, or difficulty breathing arise, immediate consultation with a physician is necessary. Elderly patients or those at risk of fluid volume loss should be cautious of dehydration or hypotension, and may require temporary discontinuation of this medication. Additionally, this medication may increase the risk of genital fungal infections, so treatment is needed if symptoms of infection appear. Glucose may be detected on urinalysis during the course of this medication, so please be aware. Pregnant or breastfeeding women are advised to avoid the use of this medication, and it should be discontinued upon confirmation of pregnancy. Safety and efficacy in pediatric patients have not been established, therefore it should not be used in patients under 18 years of age. In the case of overdose, appropriate treatment should be administered based on the patient's condition; the removal effect through hemodialysis is not known. This medication should be kept out of the reach of children and is not recommended to be transferred to another container. Caution should be taken when driving or operating machinery considering the risk of hypoglycemia. Finally, while this medication aids in blood sugar control, appropriate dose adjustments and regular monitoring are required based on the patient’s condition.

Serious side effects

• Urticaria
• angioedema
• ketoacidosis
• urinary tract sepsis
• pyelonephritis
• perineal necrosis

Mild side effects

• Hypoglycemia
• vulvovaginal candidiasis
• external genital inflammation
• balanitis
• and other genital infections
• increased urination
• rash
• itching
• decreased fluid volume
• increased serum lipids

This medication should be stored in a tightly closed container to prevent air or moisture from entering. It should be kept at normal room temperature between 1 to 30 degrees Celsius, avoiding excessively hot or cold places.

Appearance

Pale yellow oval film-coated tablet

Package unit

30 tablets/PTP (10 tablets/PTP×3), 10 tablets/PTP (10 tablets/PTP×1)