Empalil Tablet 10 mg (Empagliflozin)

Adult dose

The recommended dose of this drug is 10 mg once daily for monotherapy and additional combination therapy with other hypoglycemic agents such as Insulin. If a patient has good tolerance to 10 mg of this drug and requires additional blood sugar control, the dose may be increased to 25 mg once daily. This drug can be taken regardless of meals and should be swallowed whole. Do not take twice the dose in one day.

This drug should not be administered to certain patients. For example, individuals with allergies to the active ingredient or components of this drug, patients with type 1 diabetes, or individuals suffering from diabetic ketoacidosis should not take this medication. Additionally, this drug is not suitable for patients with severely impaired kidney function, those with end-stage kidney disease, or those on dialysis. This drug contains lactose, so individuals with genetic issues such as lactose intolerance or galactose intolerance should not take it. Patients with slightly reduced kidney function should take this drug cautiously at a controlled dose, and if kidney function worsens, treatment should be discontinued. This medication is not used for patients with end-stage kidney disease or those on dialysis, as its efficacy is not expected. In patients with heart failure, it should be used cautiously in mild to moderate cases, and it is not recommended for severe heart failure patients. When taken together with diabetes medications such as Insulin or Sulfonylureas, there may be a risk of hypoglycemia, so dose adjustments may be necessary. When taking this drug, side effects such as hypoglycemia, genital infections, increased urination, urinary tract infections, and reduced fluid volume may occur, so care is needed. Particularly, if symptoms of genital infections or urinary tract infections appear, immediate consultation with healthcare professionals is necessary. Post-marketing, there have been reports of serious side effects such as ketoacidosis, pyelonephritis, and necrotizing fasciitis, and immediate treatment should be sought if related symptoms occur. Elderly patients, especially those over 75 years, are at higher risk of fluid loss, so caution is needed during administration, and it is not recommended for those over 85 years. This drug may affect the body's hydration status, so patients at risk of dehydration or hypotension should consult healthcare professionals before taking it. Caution is also required when driving or operating machinery due to the risk of hypoglycemia, especially when taken in combination with Insulin, etc. Pregnant women should avoid taking this drug, and treatment should be discontinued immediately if pregnancy is confirmed. For breastfeeding women, it is also safe to discontinue breastfeeding while taking this medication. Children, i.e., those under 18 years of age, should not take this drug as its safety and efficacy have not been established.

Serious side effects

Hives, angioedema, necrotizing fasciitis, ketoacidosis, urosepsis, pyelonephritis, severe allergic reactions, severe skin reactions, significant edema or urination abnormalities, liver abnormalities (jaundice), kidney damage, acute renal injury, acute cholecystitis, autoimmune hepatitis, gallstones, deep vein thrombosis, angina, Prinzmetal angina, coronary artery disease, acute pyelonephritis, fever, elevated blood pressure, headache, cerebral infarction, intracranial bleeding

Mild side effects

• Hypoglycemia
• itching
• rash
• increased urination
• vulvovaginitis
• balanitis
• urinary tract infection
• thirst
• elevated serum lipids
• increased serum creatinine

This medication should be stored in a tightly closed container to protect it from air and moisture, at room temperature between 1 and 30 degrees Celsius. This helps maintain the drug's efficacy and ensures safe use.

Appearance

Light yellow, biconvex, round film-coated tablets

Package unit

10 tablets/box [(10 tablets/PTP)*1], 30 tablets/box [(10 tablets/PTP)*3], 30 tablets/bottle