Gyro Tablet 10 mg (Empagliflozin)

Adult dose

The recommended dose of this medication is 10 mg once daily, both as monotherapy and in combination therapy with other antihyperglycemic agents such as insulin. If a patient tolerates a dose of 10 mg well but requires additional blood sugar control, the dose may be increased to 25 mg once daily. When administered in conjunction with sulfonylureas or insulin, the dose of these agents may need to be decreased to reduce the risk of hypoglycemia.

This medication should not be used in patients with an allergy to the active ingredient or any other components. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. It should not be used in patients with severely impaired kidney function, defined as a glomerular filtration rate of less than 30 mL/min/1.73m² or those with end-stage renal disease or on dialysis. This medication contains lactose, therefore it should not be administered to patients with lactose intolerance, galactose intolerance, or hereditary lactase deficiency. In patients with slightly impaired kidney function, careful monitoring is required, with potential need for dose adjustment or discontinuation during treatment. The use of this medication is not recommended in patients with severe heart failure, and caution should also be exercised in mild cases. When used in conjunction with insulin or insulin secretagogues, the risk of hypoglycemia may increase, necessitating potential dose reduction of these medications. While using this medication, individuals should be cautious of possible side effects such as hypoglycemia, genital infections, urinary tract infections, increased urination, and decreased fluid volume. Particularly, serious metabolic acidosis known as ketoacidosis may occur, and immediate treatment should be sought if symptoms appear; this medication should be discontinued. Elderly patients or those at risk of fluid volume depletion should be closely monitored for symptoms of dehydration and low blood pressure. This medication may increase the risk of serious infections such as urosepsis, pyelonephritis, and necrotizing fasciitis, necessitating prompt treatment for any signs of infection. Use during pregnancy is not recommended, and it should be discontinued if pregnancy is confirmed. Use during breastfeeding is also not recommended, thus breastfeeding should be stopped. The safety and efficacy of this medication in children under 18 have not been established. In case of overdose, appropriate treatment should be sought; there is no information on whether this medication can be removed by hemodialysis. Store this medication in a tightly sealed container away from children's reach and do not transfer to other containers. When driving or operating machinery, caution should be exercised considering the risk of hypoglycemia. Regular monitoring of kidney function, fluid status, and signs of infection during medication use is essential.

Serious side effects

Hives, angioedema, severe swelling (edema), ketoacidosis, urosepsis, pyelonephritis, necrotizing fasciitis, cold sweat, pallor, difficulty breathing, asthma attack, respiratory issues, yellowing of skin or eyes (jaundice), liver anomalies, sudden and severe headache, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, significantly reduced urine output, extreme generalized edema with elevated blood pressure, severe swelling or abdominal

Mild side effects

• Hypoglycemia
• vulvovaginal candidiasis
• vulvitis
• balanitis and other genital infections
• increased urination
• rash
• itching
• headache
• orthostatic dizziness
• dizziness

This medication should be stored in a tightly sealed container to avoid exposure to air and moisture. The storage temperature should be maintained between 1 to 30 degrees Celsius.

Appearance

Light yellow, biconvex, round film-coated tablet

Package unit

10 tablets/box [(10 tablets/PTP × 1)], 30 tablets/box [(10 tablets/PTP × 3)], 30 tablets/bottle