Medication info
Empagliflozin 2L-Proline/Metformin 12.5/500 mg Tablet

Empagliflozin 2L-Proline/Metformin 12.5/500 mg Tablet

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin 2L-Proline›18.88mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
(주)경보제약
Appearance
Pale purple oval film-coated tablet
Packaging
30 tablets/bottle, 60 tablets/bottle
Approval status
Active

MFDS item code 202502977 · Approved 2025.11.18

Summary

Main use
Effect on blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage is 1 tablet at a time, twice a day. The maximum recommended daily dosage for each ingredient is 25 mg of Empagliflozin and 2000 mg of Metformin. If a patient cannot achieve sufficient blood sugar control with Metformin alone or in combination with other medications like insulin, the recommended dosage is 5 mg of Empagliflozin twice a day (a total of 10 mg daily) along with the current dose of Metformin. The tolerance is excellent.

Ingredients

Manufacturer
(주)경보제약

Efficacy & effects

Effect on blood sugar control in type 2 diabetes and prevention of cardiovascular events

  • Type 2 diabetes
  • poor blood sugar control
  • cardiovascular disease
View approved original text

This medication is used as an adjunct to diet and exercise to improve blood sugar control in patients with type 2 diabetes. It is particularly suitable for patients whose blood sugar is not adequately controlled, and it should be used cautiously in patients with cardiovascular disease. It is important to reference expert clinical trial information before starting this medication. This medication effectively helps with blood sugar management and contributes to the prevention of diabetes-related complications.

How to take

Adult dose

The recommended dosage is 1 tablet at a time, twice a day. The maximum recommended daily dosage for each ingredient is 25 mg of Empagliflozin and 2000 mg of Metformin. If a patient cannot achieve sufficient blood sugar control with Metformin alone or in combination with other medications like insulin, the recommended dosage is 5 mg of Empagliflozin twice a day (a total of 10 mg daily) along with the current dose of Metformin. The tolerance is excellent.

Precautions

This medication can cause a rare side effect called severe lactic acidosis, so it should be used with caution, especially in patients with impaired kidney function, heart disease, or liver disease. When used in combination with other diabetes medications, hypoglycemic symptoms may occur, so blood sugar levels should be closely monitored. This medication should not be used in patients with moderate or severe renal impairment or in cases where acute kidney injury is suspected. It may be temporarily discontinued when a patient is in an unstable state, such as during acute infections, dehydration, severe trauma, or around surgery. Pregnant women or those who may become pregnant, and nursing mothers are advised not to take this medication. Elderly patients should have their kidney function regularly monitored due to a higher risk of renal impairment. This medication may increase the risk of urinary tract infections and genital infections, so medical consultation should be sought immediately in case of infection symptoms. Patients with dehydration or low blood pressure should be particularly cautious, as this medication may cause fluid loss; it may be temporarily discontinued if necessary. Vitamin B12 deficiency may occur, so those on long-term treatment should regularly check their vitamin B12 levels. It is important to avoid alcohol while taking this medication. If sudden fatigue, muscle pain, or breathing difficulties occur, visit the hospital immediately. Additionally, as this medication can affect blood sugar control, blood sugar levels should be checked regularly, and dosages should be adjusted as instructed by a healthcare provider. Before surgery or tests that involve contrast agents, this medication should be discontinued and resumed only after kidney function has returned to normal. During treatment with this medication, symptoms of hypoglycemia, lactic acidosis, and ketoacidosis should be carefully monitored, and any abnormal symptoms should be reported to healthcare professionals immediately.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweats, pallor, severe allergic reaction
  • Severe rash with fever, blisters, skin peeling, mucosal pain in the mouth/eyes, severe skin adverse reactions
  • Difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever
  • Jaundice (yellowing of the skin or eyes), extreme lethargy, liver abnormalities (jaundice)
  • Sudden and severe headache

Mild side effects

  • Hypoglycemia
  • urinary tract infections
  • genital infections
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • abnormal liver function tests
  • hepatitis
  • taste disturbances
  • itching
  • rash
  • erythema
  • thirst
  • decreased and deficient vitamin B12
  • fluid volume decrease
  • increased blood creatinine
  • decreased glomerular filtration rate
  • headache
  • dizziness
  • insomnia
  • fatigue
  • weakness
  • fever
  • increased blood lipids
  • weight loss
  • pruritus of the vulva
  • pruritus of the genital area

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air and should be kept at room temperature between 1 to 30 degrees Celsius. Proper storage maintains the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Pale purple oval film-coated tablet

Package unit

30 tablets/bottle, 60 tablets/bottle

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.