Medication info
Empagazmet Tablet 12.5/1000 Milligrams (Empagliflozin 2L-Proline, Metformin)

Empagazmet Tablet 12.5/1000 Milligrams (Empagliflozin 2L-Proline, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin 2L-Proline›18.88mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
(주)경보제약
Appearance
Dark purple oval film-coated tablet
Packaging
30 tablets/bottle, 60 tablets/bottle
Approval status
Active

MFDS item code 202502978 · Approved 2025.11.18

Summary

Main use
Effectiveness in controlling blood sugar in type 2 diabetes and preventing cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage for this medication is 1 tablet per dose, twice a day. For patients who cannot achieve sufficient blood sugar control with metformin alone or in combination with other medications such as insulin, take 5 mg of empagliflozin twice a day (total daily amount 10 mg) along with the existing dosage of metformin. If tolerance to 10 mg of empagliflozin (total daily amount) is good but additional blood sugar control is needed, the dose may be increased to 25 mg of empagliflozin.

Ingredients

Manufacturer
(주)경보제약

Efficacy & effects

Effectiveness in controlling blood sugar in type 2 diabetes and preventing cardiovascular events

  • Adult type 2 diabetes
  • abnormal blood sugar control
  • cardiovascular disease
View approved original text

This medication is used to improve blood sugar control in adult patients with type 2 diabetes, in combination with metformin and lifestyle interventions such as diet and exercise. Special caution is necessary for patients with type 2 diabetes who have cardiovascular disease, as they may have an increased risk of cardiovascular events, and consultation with a healthcare professional is recommended. This medication is used to effectively lower blood sugar levels and assist in diabetes management.

How to take

Adult dose

The recommended dosage for this medication is 1 tablet per dose, twice a day. For patients who cannot achieve sufficient blood sugar control with metformin alone or in combination with other medications such as insulin, take 5 mg of empagliflozin twice a day (total daily amount 10 mg) along with the existing dosage of metformin. If tolerance to 10 mg of empagliflozin (total daily amount) is good but additional blood sugar control is needed, the dose may be increased to 25 mg of empagliflozin.

Precautions

This medication can cause severe lactic acidosis, so if symptoms related to lactic acidosis occur, discontinue use immediately and seek medical attention. Caution is advised when used in conjunction with other diabetes medications due to the risk of hypoglycemia. Patients with moderate to severe renal impairment or acute kidney problems should not take this medication. In situations that may affect renal function such as acute infections, heart problems, pre- and post-surgery, or dehydration, the use of this medication should be avoided or temporarily discontinued. Pregnant or breastfeeding women should not use this medication, and it is not recommended for children under 18 years of age. This medication may increase the risk of urinary tract infections and genital infections, so quick treatment is necessary if infection symptoms arise. Patients at risk of fluid loss or dehydration should use this medication with caution, particularly elderly patients, who should be closely monitored for hydration status. Regular monitoring is needed as liver function abnormalities or heart function decline may occur during treatment with this medication. There is a risk of hypoglycemia, therefore dose adjustments may be necessary when used with insulin or sulfonylureas. Vitamin B12 deficiency may occur, and it is advisable to check blood Vitamin B12 levels during prolonged use. Alcohol consumption can increase the risk of lactic acidosis, so excessive drinking should be avoided while using this medication. This medication may interact with other drugs; therefore, individuals taking other medications should consult with a physician or pharmacist. In the case of overdose, seek medical care immediately, and blood dialysis may be required. Keep out of reach of children, and store in the original container to maintain quality. Immediately inform healthcare professionals if any unusual symptoms such as fever, pain, or swelling occur around the perineum during treatment with this medication.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, necrotizing fasciitis of the perineum, urosepticemia, pyelonephritis, lactic acidosis, ketoacidosis, acute kidney injury, cerebral infarction, myocardial infarction, hepatitis, acute cholecystitis, autoimmune hepatitis, cholelithiasis, liver abnormalities (yellowing of skin or eyes), severe allergic reactions (hives, severe swelling, chest tightness, difficulty breathing, sweating, pallor), severe skin reactions (severe rash with high fever,

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 blood sugar
  • decreased and deficiency of Vitamin B12
  • decreased fluid volume
  • headache
  • dizziness
  • fever
  • chest discomfort
  • insomnia
  • musculoskeletal pain
  • weight loss
  • anxiety
  • mild shortness of breath
  • coughing
  • residual phlegm
  • none

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Also, avoid extremely hot or cold places, and storing at room temperature between 1 to 30 degrees Celsius is recommended.

Appearance and packaging

Appearance

Dark 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.

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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.