Empagduo Tablet 5/500 mg

Adult dose

The recommended dosage of this medication is 1 tablet, twice a day. The dosage should be determined considering each patient's current therapy, efficacy, and tolerability, while not exceeding the maximum daily recommended doses of empagliflozin 25 mg and metformin 2000 mg for each component. For patients who cannot achieve adequate blood sugar control with monotherapy of metformin alone or in combination with other medications such as insulin, the recommended dosage is empagliflozin 5 mg taken twice daily (total daily dosage of 10 mg) combined with their current metformin dosage. If tolerability to empagliflozin 10 mg (total daily dose) is good and additional blood sugar control is necessary, the dose can be increased to empagliflozin 25 mg (total daily dosage). Patients switching to this medication from treatments involving empagliflozin (total daily dose of 10 mg or 25 mg) and metformin should continue their existing doses of empagliflozin and metformin. When combining with sulfonylurea or insulin, reducing the doses of sulfonylurea or insulin may be considered to decrease the risk of hypoglycemia (see precautions regarding adverse reactions 4 and interactions 6). This medication should be taken with food to reduce gastrointestinal side effects associated with metformin. If a dose is missed, take it as soon as remembered; however, do not double the dose at once, and skip the missed dose if that occurs. Special groups: Patients with renal impairment: Dose adjustments are not needed for mild renal impairment. This medication contains metformin; therefore, it may be used with dose adjustments in patients with an estimated glomerular filtration rate (eGFR) of 45-59 ml/min/1.73 m² or creatinine clearance (CrCl) of 45-59 ml/min if they do not have other symptoms that would increase the risk of lactic acidosis. In such patients, the starting dose of metformin is 500 mg or 850 mg once daily, thus initiating treatment with individual active ingredients of empagliflozin and metformin. The maximum daily dose of metformin hydrochloride that can be administered is 1000 mg, given as 500 mg twice daily. Kidney function should be closely monitored every 3-6 months (refer to precautions regarding patients requiring careful administration, section 3). If CrCl < 45 ml/min or eGFR < 45 ml/min/1.73 m² indicates diminishing kidney function, this medication should be discontinued immediately (refer to precautions regarding patients who should not be given this medication, section 2). Elderly: Patients over 75 years old should consider the risks of reduced kidney function and fluid volume depletion.

This medication can cause a rare but serious side effect called lactic acidosis. Lactic acidosis occurs when there is an excessive buildup of lactate in the body, which may present with symptoms such as difficulty breathing, muscle pain, malaise, and abdominal pain. Additionally, this medication may increase the risk of hypoglycemia when taken in combination with other diabetes drugs, so blood sugar levels should be monitored frequently. This medication should not be used in patients with severely impaired kidney function, acute kidney problems, severe infections, or those with unstable heart conditions. Patients receiving iodinated contrast agents used in radiological studies should temporarily suspend this medication before and after the examination and resume only after kidney function has returned to normal. Pregnant or nursing women should not take this medication, and women who may become pregnant should also avoid it. This medication can cause fluid loss, so caution is advised in cases of dehydration symptoms, diarrhea, or vomiting. Regular monitoring of kidney function, blood sugar, and vitamin B12 levels is necessary while on this medication. This medication may increase the risk of genital infections and urinary tract infections, so any signs of infection should lead to immediate consultation with a physician. The elderly, malnourished patients, and those who consume excessive alcohol should be particularly cautious due to increased risks of hypoglycemia and lactic acidosis. Patients undergoing surgery should stop this medication 48 hours before the procedure and only resume after kidney function has returned to normal following the surgery. During the course of treatment, symptoms of hypoglycemia and lactic acidosis should be carefully monitored, and any abnormal symptoms should be reported to healthcare personnel immediately. Also, caution is necessary when driving or operating machinery, so the patient's condition should be assessed thoroughly. In case of overdose, it is essential to visit a hospital immediately for appropriate treatment, especially if symptoms of lactic acidosis occur, which require prompt intervention. This medication is not recommended for children and should be stored out of reach of children.

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweats, pallor, severe allergic reactions, severe rashes, blisters, skin peeling, pain in oral/ocular mucosa, severe skin reactions, asthma attacks, respiratory issues along with cough + fever, breathing problems, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache,

Mild side effects

• Hypoglycemia
• urinary tract infection
• genital infection
• increased urination
• nausea
• vomiting
• diarrhea
• abdominal pain
• loss of appetite
• constipation

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is room temperature between 1 and 30 degrees Celsius. This will help maintain the effectiveness and safety of the medication for a long time.

Appearance

Orange-yellow, bilaterally convex oval film-coated tablet

Package unit

10 tablets/box [10/PTP X 1], 60 tablets/box [10/PTP X 6], 60 tablets/bottle