Kwangdong Empaglo Tablets 10 mg (Empagliflozin)

Adult dose

The recommended dosage of this medication is 10 mg once daily for monotherapy and as an adjunctive therapy with insulin or other hypoglycemic agents. If good tolerance is achieved with this medication and further blood sugar control is needed, the dosage can be increased to 25 mg once daily. This medication can be taken regardless of meals, and the tablet should be swallowed whole. If a dose is missed, take it as soon as remembered, but do not take double the dose in one day.

This medication should not be used in patients who have allergies to the active or inactive ingredients. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. This medication is not to be used in patients with severely impaired renal function, that is, those with a glomerular filtration rate of less than 30 mL/min/1.73m2, end-stage kidney disease patients, or those undergoing dialysis. This medication contains lactose and should not be administered to patients with lactose intolerance, galactose intolerance, hereditary lactase deficiency, or glucose-galactose malabsorption. Caution is advised when administering to patients with slightly impaired renal function, and the dosage should be adjusted or discontinued if renal function continues to decline. In patients with heart failure classified as NYHA class I-II, caution is advised, while use is not recommended in patients classified as class III-IV. Coadministration with insulin or sulfonylureas may increase the risk of hypoglycemia, thus adjustment of their dosages may be necessary. During treatment with this medication, adverse reactions such as hypoglycemia, genital infections, urinary tract infections, increased urination, and decreased fluid volume may occur. There is a particular risk of serious conditions such as ketoacidosis, thus immediate consultation with a healthcare professional is advised upon symptom occurrence. Elderly patients or those at risk of fluid volume loss should be cautious due to the potential for low blood pressure or dehydration. This medication increases the risk of genital fungal infections, so appropriate treatment is necessary if related symptoms arise. Regular monitoring of kidney function and fluid status during treatment is important. Use during pregnancy should be avoided, and breastfeeding should be discontinued if necessary. Safety and effectiveness in children under 18 years of age have not been established. No specific toxic symptoms have been reported in case of overdose, but appropriate treatment is necessary depending on the clinical condition. This medication should be kept out of the reach of children and should not be transferred to other containers. Particular caution should be taken when driving or operating machinery, especially when taken with insulin or sulfonylureas due to the increased risk of hypoglycemia. Serious side effects, such as limb amputation or perineal necrosis, have been rarely reported; hence, immediate consultation with a healthcare professional should be sought if related symptoms appear.

Serious side effects

• Urticaria
• angioedema
• ketoacidosis
• rash
• perineal necrosis
• urosepsis
• pyelonephritis

Mild side effects

• Vulvovaginal candidiasis
• vulvitis
• balanitis and other genital infections
• hypoglycemia
• pruritus
• rash
• decreased fluid volume
• increased urination
• urination difficulties
• interstitial nephritis

This medication should be stored in a tightly closed container to protect it from air and moisture. Additionally, it is recommended to keep the medication at room temperature between 1°C and 30°C, avoiding extremes of heat or cold.

Appearance

Pale yellow round film-coated tablet

Package unit

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