Empagduo Tablet 5/1000 mg

Adult dose

The recommended dosage of this medicine is 1 tablet per dose, twice daily. The determination must consider each patient's current treatment regimen, efficacy, and tolerance within the maximum recommended daily limits of 25 mg of empagliflozin and 2000 mg of metformin. For patients unable to achieve adequate blood glucose control with monotherapy of metformin or in combination with other medications such as insulin, the recommended regimen consists of 5 mg of empagliflozin twice daily along with the existing dose of metformin. If necessary

This medicine can cause severe lactic acidosis, with reported cases of deaths resulting from it, so extreme caution is required. When using this drug in combination with other diabetes treatments, serious hypoglycemia may occur infrequently, so caution is needed. Patients with allergies to the ingredients in this medicine or moderate to severe renal impairment should not use this medicine. It should not be administered to patients with acute renal function deterioration, severe infections, cardiovascular issues, type 1 diabetes, or diabetic ketoacidosis. Before and after undergoing tests that use iodine contrast agents, administration of this medicine should be stopped and restarted only after normal renal function has been restored. In cases where surgery is planned, this medicine should be temporarily ceased 48 hours prior to surgery and resumed only after verifying normal renal function post-operation. It is safest for women who are pregnant or may become pregnant, as well as breastfeeding mothers, not to use this medicine. The use and dosage of this medicine should be adjusted according to renal function; particularly, elderly patients or those with impaired renal function should regularly monitor their kidney function. This medicine may cause side effects such as hypoglycemia, urinary infections, reproductive infections, increased urination, nausea, vomiting, diarrhea, abdominal pain, loss of appetite, constipation, liver enzyme abnormalities, hepatitis, altered taste, itching, rash, erythema, increased serum lipids, increased serum creatinine, decreased serum creatinine, decreased vitamin B12 and deficiency, fluid volume reduction, headaches, dizziness, insomnia, chest discomfort, chest pain, weakness, fever, peripheral edema, facial swelling, and increased blood pressure, thus any abnormal symptoms should be immediately discussed with healthcare personnel. Fluid loss may occur, so patients experiencing dehydration symptoms or at high risk for fluid volume loss should be cautious while taking this medicine. Patients with liver dysfunction should avoid this medicine, and if liver dysfunction symptoms appear, they should promptly inform their physician. This medicine may reduce vitamin B12 levels, so patients on long-term treatment should periodically check their vitamin B12 levels. Excessive alcohol consumption should be avoided while taking this medicine as it may increase the risk of lactic acidosis. While taking this medicine, it is necessary to maintain a regular meal and exercise routine for blood sugar control, as irregular meals or excessive exercise may increase the risk of hypoglycemia. The effects of this medicine on driving or operating machinery are not well-defined, so caution is advised. In cases of overdose, emergency measures such as hemodialysis may be required, so the dosage must be strictly adhered to. This medicine is not recommended for children and adolescents under 18 years old, as safety and efficacy have not been established in this population. This medicine should be taken strictly according to a physician's prescription and instructions, and any occurrence of unusual symptoms should be immediately discussed with healthcare personnel.

Serious side effects

Hives, angioedema, perineal necrosis, ketoacidosis, lactic acidosis, severe edema, acute kidney damage, acute pyelonephritis, urinary sepsis, sepsis, myocardial infarction, cerebral infarction, intracranial aneurysm, acute cholecystitis, autoimmune hepatitis, cholelithiasis, hepatitis, severe allergic reactions, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by coughing and fever, yellowing of the skin or eyes

Mild side effects

• Hypoglycemia
• urinary infections
• reproductive infections
• increased urination
• nausea
• vomiting
• diarrhea
• abdominal pain
• loss of appetite
• constipation

This medicine can be sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 degree and 30 degrees Celsius to safely preserve the effectiveness of the medicine.

Appearance

Brownish yellow, bilaterally convex oval film-coated tablets

Package unit

10 Tablets/Box [10 Tablets/PTPX1], 60 Tablets/Box [10 Tablets/PTPX6], 60 Tablets/Bottle