Empagliflozin/Metformin Hydrochloride Tablet 5/500 mg (Empagliflozin, Metformin Hydrochloride)

Adult dose

The recommended dose of this medication is 1 tablet by mouth, twice daily. The dose should be determined considering the current therapy, efficacy, and tolerability, without exceeding the daily maximum recommended doses of empagliflozin 25 mg and metformin 2000 mg. Patients who cannot achieve adequate blood sugar control with metformin alone or in combination with other medications such as insulin should take empagliflozin 5 mg twice daily (total daily amount of 10 mg).

This medication helps regulate blood sugar levels. Serious side effects such as lactic acidosis may occur while taking this medication, so caution is advised. Lactic acidosis is a condition arising from an excessive accumulation of lactic acid in the body, with symptoms including fatigue, muscle pain, difficulty breathing, abdominal pain, etc. Furthermore, if this medication is taken with other antidiabetic agents, there is a risk of hypoglycemia, so blood sugar changes should be closely monitored. Patients with decreased kidney function or severe kidney disease should not take this medication. It should also be avoided in cases of acute infections, dehydration, heart problems, severe trauma, or liver dysfunction as risks may arise. Before and after undergoing examinations with iodinated contrast agents, temporarily discontinuing this medication is necessary, and it should not be resumed until kidney function is confirmed to be normal after the examination. Women who are pregnant or breastfeeding should not take this medication, and women who may become pregnant should consult prior to use. This medication may lead to fluid loss, so caution is warranted in cases of dehydration, diarrhea, or vomiting. Regular checks of kidney function, including serum creatinine levels, should be done during treatment, especially in the elderly who should be particularly cautious about kidney function. This medication may increase the risk of genital and urinary tract infections, so consult a doctor immediately if symptoms of infection arise. Vitamin B12 levels may decrease with long-term use, so regular blood tests are recommended. Alcohol consumption can increase the risk of lactic acidosis, so avoid excessive drinking while using this medication. No special effects have been reported concerning driving or operating machinery, but caution should be exercised as hypoglycemic symptoms may occur. Regular blood sugar and kidney function tests are necessary during treatment, and if unusual symptoms occur, consult a doctor promptly. In the event of an overdose, immediate medical attention is required, and blood dialysis may be necessary.

Serious side effects

• Urticaria
• angioedema
• necrotizing fasciitis
• ketoacidosis
• lactic acidosis
• urosepsis and pyelonephritis
• severe lactic acidosis
• severe allergic reactions
• severe cutaneous adverse reactions
• acute kidney injury

Mild side effects

Hypoglycemia, urinary tract infection, genital infection, increased urination, nausea, vomiting, diarrhea, abdominal pain, loss of appetite, constipation, abnormal liver function tests, taste disturbances, erythema, thirst, decreased vitamin B12 levels and deficiency, increased serum creatinine, increased serum lipids, decreased glomerular filtration rate, vitamin B12 deficiency, dizziness, headache, orthostatic dizziness, insomnia, fatigue, peripheral edema, facial swelling, weight loss, others

Store this medication in a tightly closed container to protect it from air and moisture, at room temperatures between 1 to 30 degrees Celsius. This will help maintain the efficacy of the medication over time.

Appearance

Orange-yellow, biconvex, oval film-coated tablet

Package unit

60 tablets/bottle, 60 tablets/box [10 tablets/PTP x 6]