Selpam Tablet 10 mg (Empagliflozin)

Adult dose

The recommended dosage of this medication is once daily at 10 mg for monotherapy and for additional combination therapy with insulin or other antidiabetic medications. If the 10 mg dosage is well tolerated and additional blood sugar control is needed, the dosage can be increased to 25 mg once daily. This medication can be taken regardless of meals. The tablet should be swallowed whole. If a dose is missed, take it as soon as remembered.

This medication should not be used by patients who have allergic reactions to the active ingredient or any component. This medication should not be administered to type 1 diabetes patients or those with diabetic ketoacidosis. It is not recommended for patients with significantly impaired kidney function, that is, with a glomerular filtration rate of less than 30 mL/min/1.73 m², or those with end-stage renal disease, or those undergoing dialysis. This medication contains lactose, so it should not be administered to patients with genetic metabolic disorders such as lactose intolerance or galactose intolerance. It should be used cautiously in patients with slightly impaired kidney function, and if kidney function continues to deteriorate, dosage adjustment or discontinuation of the medication may be necessary. In cases of mild to moderate heart failure, it should be used cautiously, and it is not recommended for patients with severe heart failure. When used in combination with insulin or sulfonylureas, there may be an increased risk of hypoglycemia, so dosage adjustments may be necessary. The most common side effect of this medication is hypoglycemia, and caution is needed, especially when used with other antidiabetic medications. Genital or urinary tract infections may occur, and immediate treatment is necessary if symptoms appear. Increased urination may occur, which can lead to discomfort. There is a risk of decreased blood volume leading to lowered blood pressure or dehydration, so elderly patients or those with hypotension should be cautious. Serious metabolic abnormalities such as ketoacidosis may occur; if symptoms such as vomiting, abdominal pain, or difficulty breathing appear, immediate hospital visit is required. There have been reported cases of liver damage; if symptoms of liver dysfunction appear, the patient should consult a physician. This medication may have a mild effect on driving or operating machinery, so caution is especially needed if there is a risk of hypoglycemia. Use of this medication during pregnancy is not recommended, and it should be discontinued if pregnancy is confirmed. If breastfeeding, it is advisable to discontinue breastfeeding due to the possibility of this medication being excreted in breast milk. The safety and efficacy of this medication in children and adolescents under 18 years have not been established. No specific toxic symptoms have been reported in cases of overdose, but appropriate treatment is necessary depending on the clinical condition. This medication should be kept out of reach of children and should not be transferred to other containers. During the use of this medication, it is important to regularly monitor kidney function, and to consult medical personnel immediately if any abnormal symptoms occur.

Serious side effects

• Hives
• angioedema (severe swelling)
• ketoacidosis
• urinary tract sepsis
• pyelonephritis
• necrotizing fasciitis
• rash (severe skin reactions)

Mild side effects

• Hypoglycemia
• vulvovaginitis
• balanitis
• other genital infections
• increased urination
• difficulty urinating
• rash
• itching
• decreased blood volume
• increased serum lipids

This medication should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is best to store the medication at room temperature between 1 and 30 degrees Celsius, avoiding extremely hot or cold conditions.

Appearance

Light yellow round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP*3]