Empagliflozin 10 mg Tablet

Adult dose

The recommended dosage is 10 mg once daily as monotherapy or in combination with other antidiabetic agents such as insulin. If there is good tolerance and additional blood sugar control is needed, the dosage may be increased to 25 mg once daily. This medication can be taken with or without food. Tablets should be swallowed whole. If a dose is missed, take it as soon as remembered, but do not double the dosage for that day.

This medication should not be administered to individuals with allergies to the active ingredient or any components. It should not be used in patients with type 1 diabetes or diabetic ketoacidosis. The use of this medication is not recommended for individuals with severely impaired renal function, end-stage renal disease, or those undergoing dialysis. Additionally, it should not be taken by individuals with lactose intolerance or genetic disorders related to lactose. In patients with mildly impaired renal function, this medication should be administered with caution, and the dosage may need to be adjusted or the medication discontinued according to renal function. The medication is not effective in patients with end-stage renal disease or those undergoing dialysis. It should be used cautiously in patients with mild to moderate heart failure, and it is not recommended for those with severe heart failure. There may be a risk of hypoglycemia when taken with insulin or sulfonylureas, thus dosage adjustments may be necessary. While taking this medication, side effects such as hypoglycemia, genital infections, increased urination, urinary tract infections, and decreased fluid volume may occur, thus caution is advised. The risk of hypoglycemia may increase, especially when taken with sulfonylureas or insulin. Genital infections are more common in females, and there may be increased urination. Symptoms of low blood pressure or dehydration due to fluid volume loss may occur, warranting caution in elderly patients or those with low blood pressure. Serious metabolic disturbances such as ketoacidosis may develop, and patients should immediately notify healthcare providers if symptoms appear. The administration of this medication may be temporarily suspended in cases of acute illness or surgery leading to instability in bodily conditions. Liver damage is a possibility, so caution is advised in patients with liver dysfunction. Elderly patients are at greater risk for fluid volume loss, hence careful administration is necessary, and its use is not recommended in those aged 85 years and older. This medication may lead to severe urinary infections, such as urosepsis or pyelonephritis, thus immediate treatment is necessary if infection symptoms present themselves. The risk of genital fungal infections may also increase, and appropriate treatment is needed for related symptoms. Additionally, this medication may show a positive response in urine glucose tests, necessitating careful interpretation of test results. Caution is advised when driving or operating machinery, especially when taken with insulin or sulfonylureas due to the risk of hypoglycemia. Patients with diabetes should pay attention to foot care in daily life, as there is a rare increased risk of limb amputation. Pregnant women should avoid taking this medication, and it should be discontinued if pregnancy is confirmed. Breastfeeding mothers should also stop breastfeeding while on this medication. Safety and effectiveness in children under 18 years have not been established, so it should not be used. No specific toxic reactions have been reported in case of overdose, but appropriate treatment is necessary based on the condition of the patient. This medication should be kept out of reach of children and should not be transferred to another container.

Serious side effects

• Urticaria
• severe swelling (edema)
• angioedema
• chest tightness
• difficulty breathing
• cold sweat
• pallor
• severe rash with fever
• blisters
• skin peeling

Mild side effects

• Hypoglycemia
• vulvovaginitis
• external genital inflammation
• balanitis and other genital infections
• increased urination
• urinary tract infections
• fluid volume loss
• increased blood creatinine levels
• decreased glomerular filtration rate
• rash

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. The storage temperature should be kept between 1 degree to 30 degrees Celsius, and it is advisable to avoid extremely hot or extremely cold places.

Appearance

Light yellow, round, biconvex, film-coated tablet

Package unit

30 tablets/bottle