Selpam Tablets 25 mg (Empagliflozin)

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and additional combination therapy with other glucose-lowering agents such as insulin. If this 10 mg dose is well tolerated and additional blood sugar control is needed, it can 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, it should be taken as soon as remembered.

This medication should not be administered to specific patients. Patients with allergies to the active ingredient or components, those with type 1 diabetes, or those with diabetic ketoacidosis may be at risk when taking this medication. Patients with severely impaired renal function or those undergoing dialysis should also avoid this medication. Additionally, since this medication contains lactose, patients with genetic conditions such as lactose intolerance or galactose intolerance should not take it. Patients with slightly impaired renal function should use this medication cautiously. Especially if renal function continues to deteriorate or falls below a certain level, this medication should be discontinued. It is not effective in patients with end-stage renal disease or those undergoing dialysis. Regular monitoring of renal function is necessary, and caution should be observed before taking other medications that may affect the kidneys. In patients with mild or moderate heart failure, this medication should be used carefully, and it is not recommended for patients with severe heart failure. The risk of hypoglycemia may increase when used with insulin or insulin secretagogues. Therefore, when used in combination with these medications, it is necessary to adjust the dosage of insulin or secretagogues to prevent hypoglycemia. Common side effects that may occur while taking this medication include hypoglycemia, genital infections, increased urination, urinary tract infections, and volume depletion. Notably, genital infections may occur more frequently in women, so appropriate treatment is needed if symptoms arise. Additionally, this medication may rarely cause severe ketoacidosis; thus, if symptoms such as vomiting, abdominal pain, or difficulty breathing appear, immediate consultation with medical personnel is required. Blood pressure may decrease due to volume loss, so elderly individuals or those with low blood pressure should be cautious. Cases of liver damage have been reported concerning this medication, though a clear causal relationship is not established. Caution should be taken in patients 75 years and older due to the risk of volume loss, and it is not recommended to initiate treatment in those over 85 years. This medication may increase the risk of severe urinary tract infections such as urinary tract infections and pyelonephritis, so prompt treatment is necessary if symptoms of infection occur. There is also an increased risk of fungal infections in the genital area, so patients with a relevant history should take additional precautions. This medication may yield a positive response for glucose in urine tests, and this should be taken into account when interpreting test results. Caution is needed when driving or operating machinery due to the risk of hypoglycemia, particularly when combined with insulin or sulfonylurea. While taking this medication, there have been reports of increased risk of limb amputation, so foot care should be prioritized. Pain, swelling, or redness around the perineum may indicate a rare but serious risk of perineal necrosis, necessitating immediate treatment. This medication may interact with other medications; therefore, careful observation and dosage adjustments are needed, especially when used in combination with diuretics, insulin, or sulfonylureas. The use of this medication during pregnancy is not recommended, and if pregnancy is confirmed, it should be discontinued immediately. During breastfeeding, it is also advisable to avoid using this medication, and it is recommended to stop breastfeeding. Safety and efficacy in pediatric patients under 18 years old have not been established. No specific toxic symptoms have been reported in cases of overdose, but appropriate treatment may be necessary depending on clinical conditions. This medication should be kept out of the reach of children and should not be transferred to other containers.

Serious side effects

Urticaria, angioedema, ketoacidosis, urinary tract infections leading to urosepsis and pyelonephritis, perineal necrosis

Mild side effects

• Hypoglycemia
• vulvovaginal candidiasis
• vaginitis
• balanitis and other genital infections
• increased urination
• urination difficulties
• rash
• itching
• increased serum creatinine
• decreased glomerular filtration rate

This medication should be stored in a tightly closed container to protect it from exposure to air or moisture. Additionally, it should be stored at room temperature between 1 to 30 degrees Celsius, avoiding extremely hot or cold places.

Appearance

Light yellow oval film-coated tablet

Package unit

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