Empagliflozin 10 mg Tablet

Adult dose

The recommended dosage for this medication is 10 mg once daily for monotherapy and additional combination therapy with insulin and other hypoglycemic agents. If well tolerated with a need for additional blood glucose control, the dose can be increased to 25 mg once daily. This medication can be taken without regard to meals, and the tablet should be swallowed whole. Do not take double doses in one day.

This medication should not be used in certain patients. Patients with allergies to the active ingredient or any other components, patients with type 1 diabetes, and patients with diabetic ketoacidosis should not take this medication. Also, patients with very low kidney function or end-stage kidney disease, including those undergoing dialysis, should not use this medication. Furthermore, this medication contains lactose, so it is not to be administered to patients with lactose intolerance or related genetic conditions. In patients with slightly impaired kidney function, this medication should be used cautiously. If the glomerular filtration rate falls below a certain threshold, dose adjustment or discontinuation may be necessary. The efficacy of this medication is not expected in patients with end-stage kidney disease or who are on dialysis, and kidney function should be monitored regularly. In patients with heart failure, use caution in those with mild to moderate heart failure; it is not recommended for those with severe heart failure. There is a risk of hypoglycemia when this medication is used together with insulin or insulin secretagogues, so dosage adjustments may be necessary for these medications. Various adverse reactions may occur when taking this medication. The most common adverse reaction is hypoglycemia, especially increased risk when used in combination with insulin or sulfonylureas. Additionally, there may be an increase in genital infections such as vulvovaginal candidiasis, vulvitis, and balanitis. The frequency of urination may increase, and urinary tract infections may occur, so attention should be paid to symptoms. Decreased fluid volume may lead to signs of dehydration or hypotension, so caution is advised for older adults or those with low blood pressure. Increased blood creatinine levels or decreased glomerular filtration rate may occur, but this is usually temporary and resolves after discontinuation of the medication. Post-marketing studies have rare reports of severe adverse reactions, including ketoacidosis, urosepsis, pyelonephritis, skin rash, hives, angioedema, and perineal necrosis. If any of these symptoms occur, immediate consultation with healthcare professionals is necessary. Pregnant women are advised not to take this medication, and treatment should be discontinued upon confirmation of pregnancy. Nursing mothers should also discontinue breastfeeding while taking this medication. This medication has not been established for safety and efficacy in children under 18 years of age and should not be used in this population. No specific toxic symptoms have been reported in cases of overdose, but appropriate treatment should be sought if necessary. This medication should be kept out of the reach of children and should not be transferred to other containers. The risk of dehydration and hypotension may increase when this medication is used with other diuretics, so caution is warranted, and dosage adjustments may be necessary when used with insulin or insulin secretagogues to reduce the risk of hypoglycemia. Additionally, during the use of this medication, the 1,5-anhydroglucitol test, used for blood glucose control assessment, is unreliable, and alternative methods should be used. When driving or operating machinery, especially if used with insulin or sulfonylureas, there is a risk of hypoglycemia, so caution is advised. Diabetic patients should pay attention to foot care, as the risk of lower limb amputations, including toes, may increase while taking this medication. If symptoms such as pain, tenderness, or swelling occur near the perineum, there is a possibility of a severe infection, and healthcare professionals should be notified immediately.

Serious side effects

Hives, angioedema (severe swelling), ketoacidosis, urosepsis, pyelonephritis, perineal necrosis, abnormal urination (significantly decreased urination), acute kidney injury, acute pyelonephritis, increased blood creatinine, decreased glomerular filtration rate, severe skin adverse reactions (severe rash, blistering, skin peeling, pain in oral/ocular mucosa), severe allergic reactions, liver disorders (jaundice, skin or eyes turning yellow), serious neurological symptoms

Mild side effects

• Hypoglycemia
• vulvovaginal candidiasis
• vulvitis
• balanitis
• other genital infections
• itching
• rash
• increased urination
• difficulty urinating
• thirst

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and it is recommended to keep it in a cool place at room temperature between 1°C and 30°C. Proper storage will help maintain the effectiveness of the medication.

Appearance

Light yellow, round, biconvex film-coated tablet

Package unit

30 tablets/bottle