Empa Tablet 10 mg (Empagliflozin)

Adult dose

The recommended dosage for this medication is 10 mg once daily for both monotherapy and additional combination therapy with insulin or other glucose-lowering agents. If a patient tolerates 10 mg well and requires further blood sugar control, the dosage can be increased to 25 mg once daily. This medication can be taken regardless of meals, and the tablet should be swallowed whole. If a dose is missed, it should be taken as soon as remembered on the same day.

This medicine should not be administered to certain patients. First, patients who are allergic to the active substance or any ingredients of this medication should avoid taking it. Also, it should not be used in patients with type 1 diabetes or diabetic ketoacidosis. Patients with severely impaired kidney function, specifically those with a glomerular filtration rate of less than 30 mL/min/1.73m2, or those with end-stage renal disease or undergoing dialysis, should not take this medication. This drug contains lactose, so patients with genetic problems like lactose intolerance, galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take it. Caution is required when administering this medication to patients with mildly impaired kidney function. It is advised not to initiate this medication in patients with a glomerular filtration rate of less than 60 mL/min/1.73m2, and dosage adjustments or discontinuation may be needed in those already on it. Experience with this drug is limited in patients with heart failure, especially those with severe heart failure, so caution is warranted, and its use is not recommended in certain severe cases. Caution is necessary if this medication is taken in conjunction with insulin or sulfonylureas, as the risk of hypoglycemia may increase, possibly requiring dosage adjustments. Side effects such as hypoglycemia, genital infections, urinary tract infections, increased urination, decreased fluid volume, increased serum creatinine, among others, may occur during the use of this drug, thus symptoms should be carefully monitored. There is a risk of serious metabolic acidosis known as ketoacidosis, so if symptoms such as vomiting, abdominal pain, breathing difficulties, or malaise occur, immediate consultation with a healthcare professional is needed. Caution is required for the elderly, particularly those aged 75 and above, as the risk of hypotension or dehydration due to fluid loss may increase. This medication may also increase the risk of genital fungal infections; early treatment should be initiated if infection symptoms appear. Precautions should be taken when driving or operating machinery, particularly if combined with insulin due to the risk of hypoglycemia. It is not recommended for pregnant women, and it should be discontinued immediately if pregnancy is confirmed. During breastfeeding, as there is a possibility of this drug being secreted in breast milk, it is advisable to stop breastfeeding. Safety and efficacy in children and adolescents (under 18 years) have not been established, so it should not be used in this population. No specific toxic symptoms have been reported in cases of overdose; however, appropriate treatment may be needed based on clinical conditions. This medication must be kept out of the reach of children and transferring it to other containers is not beneficial for maintaining quality.

Serious side effects

• Hives
• angioedema
• ketoacidosis
• urosepsis and pyelonephritis
• perineal necrosis

Mild side effects

• Hypoglycemia
• vulvovaginal candidiasis
• vulvitis
• balanitis
• and other genital infections
• increased urination
• urinary tract infections
• fluid volume loss
• increased serum lipids
• increased serum creatinine

This medicine should be stored in a tightly closed container to avoid exposure to air or moisture and kept at room temperature between 1 and 30 degrees Celsius. Storing it in this manner helps maintain the drug's effectiveness.

Appearance

Light yellow round film-coated tablet

Package unit

PTP packaging - 30 tablets/PTP[10 tablets/PTPX3], PTP packaging - 10 tablets/PTP[10 tablets/PTPX1]