Medication info
Empagliflozin/Metformin Duo Tablet 5/1000 mg (Empagliflozin, Metformin Hydrochloride)

Empagliflozin/Metformin Duo Tablet 5/1000 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
일동제약(주)
Appearance
A yellow, biconvex, oval film-coated tablet with a brown hue.
Packaging
60 tablets/bottle, 60 tablets/box [10 tablets/PTP x 6]
Approval status
Active

MFDS item code 202501728 · Approved 2025.07.09 · Insurance code 642907050

Summary

Main use
Type 2 diabetes (blood sugar control) and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage of this medication is one tablet, twice daily. The dosage should be adjusted according to each patient's condition, not exceeding empagliflozin 25 mg and metformin 2000 mg. If blood sugar control is inadequate, use empagliflozin 5 mg twice daily with the existing metformin dosage. If tolerance is good, it can be increased to empagliflozin 10 mg or 25 mg. Take with meals.

Ingredients

Manufacturer
일동제약(주)

Efficacy & effects

Type 2 diabetes (blood sugar control) and prevention of cardiovascular events

  • Poor blood sugar control in patients with type 2 diabetes
  • cardiovascular disease
View approved original text

This medication is used to help control blood sugar in adult patients with type 2 diabetes when taking empagliflozin and metformin in combination. It is used in conjunction with dietary and exercise therapy to effectively improve blood sugar levels. It is particularly suitable for patients with type 2 diabetes who are not sufficiently controlling their blood sugar, and caution is needed for patients with cardiovascular diseases. These patients should refer to professional clinical trial information for safe administration. Overall, this medication helps manage diabetes by improving blood sugar control.

How to take

Adult dose

The recommended dosage of this medication is one tablet, twice daily. The dosage should be adjusted according to each patient's condition, not exceeding empagliflozin 25 mg and metformin 2000 mg. If blood sugar control is inadequate, use empagliflozin 5 mg twice daily with the existing metformin dosage. If tolerance is good, it can be increased to empagliflozin 10 mg or 25 mg. Take with meals.

Precautions

This medication is used for the treatment of type 2 diabetes and has a blood sugar-lowering effect. However, one of the ingredients, metformin hydrochloride, can rarely cause a serious condition called lactic acidosis, so caution is needed. Also, when used in combination with insulin or other diabetes medications, hypoglycemia can occur, so caution is required. This medication should not be used in patients with moderate or severe renal impairment, acute kidney problems, severe infections, heart failure, and other specific patients. Administration should be temporarily suspended before and after surgery or radiological examinations with contrast agents, and can be resumed once kidney function has returned to normal. It is advisable not to administer this medication to pregnant or breastfeeding women. During the use of this medication, regular kidney function tests should be conducted, and extra caution must be taken in situations where fluid loss is a concern. Additionally, this medication may increase the risk of urinary tract infections and genital infections, so if infection symptoms appear, immediate consultation with healthcare professionals is necessary. Monitoring of blood vitamin B12 levels may also be required due to the possibility of low levels. Alcohol consumption should be avoided as it may increase the risk of lactic acidosis during treatment. Symptoms of hypoglycemia may occur, so especially when combined with other hypoglycemic agents, careful observation of blood sugar changes is essential. Older patients or those with impaired kidney function require careful dosage adjustment and monitoring. In case of overdose, serious side effects may occur, therefore, it is crucial to adhere to the prescribed dose, and if any abnormal symptoms occur, seek medical attention immediately. This medication has not established safety and effectiveness in children and is therefore not recommended for those under 18 years of age. Finally, this medication should be stored out of the reach of children and kept in its original container to maintain its quality.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (angioedema)
  • chest tightness
  • difficulty breathing
  • ketoacidosis
  • urosepsis
  • pyelonephritis
  • perineal necrosis
  • severe allergic reactions
  • severe skin reactions
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  • respiratory problems
  • liver abnormalities (jaundice)
  • sudden and severe headaches
  • cerebrovascular accidents
  • seizures
  • confusion
  • visual disturbances
  • paralysis
  • severe swelling
  • urination abnormalities
  • lactic acidosis
  • acute kidney injury
  • acute myocardial infarction
  • sepsis
  • shock
  • cerebrovascular accidents

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
  • altered taste
  • itching
  • rash
  • erythema
  • hives
  • angioedema
  • dysuria
  • interstitial nephritis
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
  • decreased and deficiency of vitamin B12
  • decreased fluid volume
  • dizziness
  • headache
  • discomfort in the head
  • weakness

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 or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. This will help preserve the effectiveness and safety of the medication for a long time.

Appearance and packaging

Appearance

A yellow, biconvex, oval film-coated tablet with a brown hue.

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.