Medication info
Empagliflozin and Metformin Prolonged-Release Tablet 5/1000 mg (Empagliflozin, Metformin)

Empagliflozin and Metformin Prolonged-Release Tablet 5/1000 mg (Empagliflozin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
동아에스티(주)
Appearance
Gray, convex, oval-shaped prolonged-release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202501722 · Approved 2025.07.09 · Insurance code 642507890

Summary

Main use
Effectiveness in controlling blood sugar in adults with type 2 diabetes and preventing cardiovascular events
Who takes it
Adults
Adult dose
The dosage of this medication should not exceed the maximum daily dosage of 25 mg of empagliflozin and 2000 mg of prolonged-release metformin hydrochloride. This medication should be taken once daily in the evening with meals to reduce gastrointestinal adverse reactions associated with metformin. The 10/1000 mg or 25/1000 mg prolonged-release tablets are taken once daily at a dose of 1 tablet. The 5/1000 mg prolonged-release tablets or the 12.5/1000 mg tablets are taken once daily at a dose of 2 tablets.

Ingredients

Manufacturer
동아에스티(주)

Efficacy & effects

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

  • Blood sugar control abnormalities
  • type 2 diabetes
  • cardiovascular diseases
  • cardiovascular events
View approved original text

This medication is used to assist in blood sugar control in adult patients with type 2 diabetes by combining empagliflozin and metformin. It is taken as an adjunct to diet and exercise therapy to effectively manage blood sugar levels. It is particularly suitable for patients whose blood sugar is not sufficiently controlled, and caution is needed in patients with cardiovascular diseases due to the risk of cardiovascular events. This medication helps improve blood sugar control in patients with type 2 diabetes and aids in the prevention of complications.

How to take

Adult dose

The dosage of this medication should not exceed the maximum daily dosage of 25 mg of empagliflozin and 2000 mg of prolonged-release metformin hydrochloride. This medication should be taken once daily in the evening with meals to reduce gastrointestinal adverse reactions associated with metformin. The 10/1000 mg or 25/1000 mg prolonged-release tablets are taken once daily at a dose of 1 tablet. The 5/1000 mg prolonged-release tablets or the 12.5/1000 mg tablets are taken once daily at a dose of 2 tablets.

Precautions

This medication is used for the treatment of diabetes, with the main ingredients being empagliflozin and metformin. Caution is required when taking this medication as it can cause a rare side effect called lactic acidosis. Lactic acidosis is a serious condition caused by excessive buildup of lactic acid in the blood, symptoms of which may include vomiting, abdominal pain, muscle pain, and shortness of breath. Additionally, if taken with other diabetes medications, hypoglycemia symptoms may occur, so blood sugar levels should be monitored closely. This medication should not be taken by patients with moderate to severe renal impairment or acute renal injury. Regular monitoring of renal function is important. Discontinuation of this medication is necessary in cases of acute infection, dehydration, pre- and post-surgical situations, heart failure, or other serious health conditions, and it can be restarted once health improves. This medication may increase the risk of genital and urinary tract infections, so immediate consultation with healthcare professionals is advised if any infection symptoms appear. The metformin component may lower vitamin B12 levels, so it is advisable to check vitamin B12 levels regularly during long-term use. Women who are pregnant, may become pregnant, or are breastfeeding should not take this medication. Elderly patients, especially those over 75 years of age, should be especially cautious due to higher risks of fluid loss and renal impairment. Tablets should not be broken, crushed, or chewed, and should be swallowed whole; it is normal for the tablet coating to be excreted in the stool. In the event of overdose, there is a risk of hypoglycemia or lactic acidosis, so it is important to adhere to the prescribed dosage and notify healthcare providers immediately if any abnormal symptoms occur. It is advisable to avoid alcohol consumption while taking this medication, and blood sugar and renal function should be monitored regularly. Finally, this medication can interact with several other drugs, so it is essential to inform healthcare providers of any other medications being taken.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, and other severe allergic reactions.
  • Severe skin reactions accompanied by high fever, severe rashes, blisters, skin peeling, pain in mucous membranes of mouth/eyes, etc.
  • Breathing difficulties or difficulty breathing, asthma attacks, respiratory problems accompanied by coughing and fever.
  • Jaundice indicated by yellowing of the skin or eyes, profound lethargy indicating liver dysfunction.
  • Sudden and severe health complications.

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
  • taste disturbances
  • itching
  • rash
  • erythema
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  • increased serum creatinine
  • decreased glomerular filtration rate
  • decreased and deficient vitamin B12
  • increased serum lipids
  • increased urination
  • difficulty urinating
  • abnormal liver function tests
  • hepatitis
  • decreased fluid volume
  • weight loss
  • dizziness
  • headache
  • fever
  • fatigue
  • insomnia
  • chest pain
  • increased blood pressure
  • unstable angina
  • anxiety
  • anemia
  • benign prostatic hyperplasia

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

Storage

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly sealed container. The recommended storage temperature is at room temperature between 1°C and 30°C. This helps maintain the efficacy and safety of the medication.

Appearance and packaging

Appearance

Gray, convex, oval-shaped prolonged-release film-coated tablet

Package unit

30 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.