Medication info

Empagliflozin and Metformin Hydrochloride Extended-Release Tablet 5/750 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Metformin Hydrochloride with Colloidal Anhydrous Silica›757.5mg / 1 tabletEmpagliflozin›5mg / 1 tablet
Manufacturer / importer
대원제약(주)
Appearance
Pale pink, oval-shaped extended-release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202501913 · Approved 2025.07.25

Summary

Main use
Effectiveness in controlling blood sugar in type 2 diabetes and preventing cardiovascular events
Who takes it
Adults
Adult dose
This medication is taken orally once daily in the evening with meals. For the 10/1000 mg extended-release tablet or the 25/1000 mg extended-release tablet, take 1 tablet once daily. For patients taking the 5/1000 mg extended-release tablet, 12.5/1000 mg extended-release tablet, 5/750 mg extended-release tablet, or 12.5/750 mg extended-release tablet, take 2 tablets simultaneously once daily. Increase the dosage of metformin hydrochloride as necessary.

Ingredients

Manufacturer
대원제약(주)

Efficacy & effects

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

  • Abnormal blood sugar control in adult type 2 diabetes patients
  • cardiovascular disease
  • cardiovascular events
View approved original text

This medication is suitable for adults with type 2 diabetes who have difficulty controlling blood sugar, when used in conjunction with diet and exercise. In particular, it helps improve blood sugar levels by combining empagliflozin and metformin. Furthermore, caution is required for adult type 2 diabetes patients with cardiovascular disease regarding the risk of cardiovascular events. It is important to consult with a healthcare professional before use, and this medication is effectively used for controlling blood sugar and preventing related complications.

How to take

Adult dose

This medication is taken orally once daily in the evening with meals. For the 10/1000 mg extended-release tablet or the 25/1000 mg extended-release tablet, take 1 tablet once daily. For patients taking the 5/1000 mg extended-release tablet, 12.5/1000 mg extended-release tablet, 5/750 mg extended-release tablet, or 12.5/750 mg extended-release tablet, take 2 tablets simultaneously once daily. Increase the dosage of metformin hydrochloride as necessary.

Precautions

This medication is used for the treatment of diabetes and contains two components that help control blood sugar. It is essential to verify normal kidney function before taking this medication, and it should not be administered to patients with impaired kidney function. This drug should not be used in patients with serious illnesses such as severe renal impairment, acute heart failure, acute myocardial infarction, or severe infections. Additionally, individuals allergic to any components of this medication should not take it. This medication can cause a rare but very serious side effect known as lactic acidosis, so special caution is required in cases of dehydration, hypoxia, or liver dysfunction. When used in combination with other diabetes medications, hypoglycemia may occur, so dosage adjustments may be necessary when used together with insulin or sulfonylureas. This drug may increase the risk of genital and urinary tract infections, so consult a doctor immediately if any infection symptoms occur. Regular blood tests are important to monitor kidney function and vitamin B12 levels during treatment. It is advisable for pregnant women, women of childbearing potential, or nursing mothers to avoid using this medication. Elderly patients or those at risk of fluid loss should be cautious about dehydration and low blood pressure and may need to temporarily discontinue the drug if necessary. Patients scheduled for surgery should stop taking this medication 48 hours prior to surgery and resume only after confirming normal kidney function post-surgery. This drug should be swallowed whole and not chewed or crushed, and its coating may appear in stools, which is normal. Overdose can cause severe side effects like lactic acidosis, so immediate medical attention is required for any unusual symptoms. It is advisable to avoid excessive alcohol consumption while taking this medication, and any changes in symptoms or adverse reactions should be reported to a healthcare professional immediately.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • perineal necrosis
  • ketoacidosis
  • lactic acidosis
  • decreased blood pH
  • severe swelling
  • myocardial infarction
  • cerebral infarction
  • seizures
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  • confusion
  • visual disturbances
  • paralysis
  • difficulty breathing
  • asthma attacks
  • blisters
  • skin peeling
  • pain in mucous membranes of mouth/eyes
  • liver dysfunction (jaundice)
  • hypertension
  • and significantly reduced urine output
  • high fever
  • severe allergic reactions
  • severe skin reactions
  • severe neurological symptoms
  • severe swelling or

Mild side effects

  • Hypoglycemia
  • urinary tract infections
  • genital infections
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • decreased and deficiency of vitamin B12
  • abnormal liver function tests
  • hepatitis
  • altered taste
  • itching
  • rash
  • erythema
  • angioedema
  • dysuria
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
  • increased hematocrit
  • headache
  • dizziness
  • insomnia
  • fatigue
  • chest discomfort
  • chest pain
  • weight loss

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

Storage

This medication should be stored in a tightly sealed container, protected from air and moisture, and maintained at room temperature between 1 to 30 degrees Celsius. Proper storage will safely preserve the medication's effectiveness.

Appearance and packaging

Appearance

Pale pink, oval-shaped extended-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.