Medication info
Empagliflozin and Metformin Hydrochloride Tablets 12.5/500 mg (Empagliflozin, Metformin Hydrochloride)

Empagliflozin and Metformin Hydrochloride Tablets 12.5/500 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
일동제약(주)
Appearance
Light brown-purple, bilaterally convex oval film-coated tablet
Packaging
60 tablets/bottle, 60 tablets/box [10 tablets/PTP x 6]
Approval status
Active

MFDS item code 202501731 · Approved 2025.07.09 · Insurance code 642907040

Summary

Main use
Effects on blood glucose control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage of this medication is 1 tablet twice a day. The dosage should be determined considering the current treatment regimen, efficacy, and tolerance without exceeding the maximum recommended daily doses of empagliflozin 25 mg and metformin 2000 mg. For patients on monotherapy with metformin or in combination with other drugs such as insulin where glycemic control is insufficient, a recommended dosage would be 5 mg empagliflozin twice a day with the previously prescribed dose of metformin.

Ingredients

Manufacturer
일동제약(주)

Efficacy & effects

Effects on blood glucose control in type 2 diabetes and prevention of cardiovascular events

  • Abnormal blood glucose control
  • type 2 diabetes
  • cardiovascular disease
  • cardiovascular events
View approved original text

This medication is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. It is particularly suitable for patients whose blood sugar is not adequately controlled, and caution should be taken under the guidance of a healthcare professional in patients with cardiovascular disease. This medication helps improve blood glucose control and manage the risk of cardiovascular diseases.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet twice a day. The dosage should be determined considering the current treatment regimen, efficacy, and tolerance without exceeding the maximum recommended daily doses of empagliflozin 25 mg and metformin 2000 mg. For patients on monotherapy with metformin or in combination with other drugs such as insulin where glycemic control is insufficient, a recommended dosage would be 5 mg empagliflozin twice a day with the previously prescribed dose of metformin.

Precautions

This medication is used for the treatment of diabetes and helps lower blood sugar levels. However, there is a risk of rare but severe side effects such as lactic acidosis. Caution should be exercised when used with other diabetes medications, as there may be an increased risk of hypoglycemia. This medication should not be used in certain patients with severe renal impairment, acute renal problems, severe infections, heart failure, and others. Additionally, it should be temporarily discontinued before and after undergoing surgery or tests using iodinated contrast media. It is also advisable for pregnant or nursing women to avoid this medication. This medication may be affected by kidney function, and regular kidney function tests are recommended. Extra caution is needed if there is a risk of fluid loss or symptoms of dehydration. While taking this medication, patients should be aware of symptoms of hypoglycemia, and dosage adjustments may be necessary if using insulin or other hypoglycemic agents. Urinary tract or genital infections may occur during treatment; if symptoms appear, consult healthcare providers immediately. Vitamin B12 deficiency may occur; therefore, routine blood tests during long-term treatment are recommended. Alcohol consumption may increase the risk of lactic acidosis, so it is safer to avoid it. If abnormal symptoms occur while taking this medication, consult a doctor immediately. This medication is not recommended for children or teenagers under the age of 18. Elderly patients should have their dosage adjusted and monitored carefully due to the risk of reduced kidney function. In case of overdose, seek immediate medical attention; blood dialysis may be required. This medication should be stored out of reach of children and kept in its original container.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • necrotizing fasciitis
  • ketoacidosis
  • lactic acidosis
  • cerebral infarction
  • acute pyelonephritis
  • urosepsis
  • severe allergic reactions
  • liver abnormalities (jaundice)
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  • severe neurological symptoms
  • severe swelling or urinary problems
  • myocardial infarction
  • acute cholecystitis
  • autoimmune hepatitis
  • gallstones
  • acute kidney injury
  • sepsis
  • pneumonia
  • shock
  • acute myocardial infarction
  • renal failure
  • hypotension
  • hypoxia
  • acute congestive heart failure
  • and sudden headaches.

Mild side effects

  • Hypoglycemia
  • urinary tract infection
  • genital infection
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • abnormal liver function tests
  • hepatitis
  • altered taste
  • itching
  • rash
  • erythema
  • increased serum creatinine
  • decreased glomerular filtration rate
  • decreased and deficient vitamin B12
  • reduced fluid volume
  • thirst
  • headache
  • dizziness
  • fatigue
  • insomnia
  • weight loss
  • chest discomfort
  • chest pain
  • weakness
  • fever
  • arteriosclerosis
  • hypertension
  • and instability.

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. The recommended storage temperature is between 1 and 30 degrees Celsius at room temperature to maintain its effectiveness.

Appearance and packaging

Appearance

Light brown-purple, bilaterally convex oval film-coated tablet

Package unit

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

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.