Medication info
Empagliflozin/Metformin Extended-Release Tablets 5/1000 mg (Empagliflozin, Metformin)

Empagliflozin/Metformin Extended-Release Tablets 5/1000 mg (Empagliflozin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
삼진제약(주)
Appearance
Pale yellow rectangular extended-release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202502002 · Approved 2025.07.31 · Insurance code 647805920

Summary

Main use
Blood sugar control in adults with type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
This medication should be taken once daily in the evening with food to minimize gastrointestinal side effects from metformin. The 10/1000 mg extended-release tablets or the 25/1000 mg extended-release tablets should be taken once daily, one tablet per dose. Patients taking the 5/1000 mg or 12.5/1000 mg extended-release tablets should take two tablets at once, once daily. Dosage associated with the use of metformin.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Blood sugar control in adults with type 2 diabetes and prevention of cardiovascular events

  • Blood sugar control issues in adults with type 2 diabetes
  • inadequately controlled blood sugar
  • cardiovascular disease
View approved original text

This medication helps improve blood sugar control in adult patients with type 2 diabetes when used with diet and exercise. It is particularly suitable for adult patients whose blood sugar is not sufficiently controlled and may also be used in those with cardiovascular disease. However, detailed effects on cardiovascular events should be referred to in professional information. This medication is effectively used for diabetes management.

How to take

Adult dose

This medication should be taken once daily in the evening with food to minimize gastrointestinal side effects from metformin. The 10/1000 mg extended-release tablets or the 25/1000 mg extended-release tablets should be taken once daily, one tablet per dose. Patients taking the 5/1000 mg or 12.5/1000 mg extended-release tablets should take two tablets at once, once daily. Dosage associated with the use of metformin.

Precautions

This medication is a combination drug used for the treatment of type 2 diabetes, helping to regulate blood sugar levels. It should not be administered to patients with impaired kidney function and should be avoided in those with acute kidney problems or severe infection. This medication is not used in patients with severe liver dysfunction or acute or unstable heart failure. During treatment, a rare complication known as lactic acidosis can occur, so if symptoms (such as fatigue, muscle pain, difficulty breathing, abdominal pain, etc.) arise, consult a physician immediately. Also, this medication may increase the risk of hypoglycemia when used with other diabetes medications, so patients taking insulin or sulfonylurea group drugs may require dosage adjustments. Urinary infections or genital infections may occur, so prompt treatment should be sought if such symptoms appear. This medication can cause fluid loss, so precautions should be taken to prevent dehydration or fluid deficit. Pregnant women, women who may become pregnant, and nursing mothers are advised not to take this medication. Elderly patients may have reduced kidney function, so regular kidney function tests are necessary, and it is safe to avoid the maximum dosage. This medication should be swallowed whole without breaking, crushing, or chewing the tablets, although the tablet shell may pass in the stool, which is normal. Patients facing surgery should stop taking this medication 48 hours prior to surgery and resume after kidney function is normally restored post-surgery. When undergoing tests that use iodine contrast agents, this medication should be stopped before and after the tests, and it should be re-administered after confirming normal kidney function. Excessive alcohol consumption may increase the risk of lactic acidosis, so alcohol should be avoided during treatment. This medication can lower vitamin B12 levels, so checks for vitamin B12 deficiency may be needed during prolonged use. Finally, regularly check blood sugar control status while taking this medication and consult healthcare personnel immediately if unusual symptoms occur.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, significantly reduced urine output, severe body swelling with elevated blood pressure, lactic acidosis, ketoacidosis, perineal necrosis, urosepsis, and pyelonephritis.

Mild side effects

  • Hypoglycemia
  • decreased and deficiency of vitamin B12
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
  • abnormal liver function tests
  • hepatitis
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  • taste alteration
  • itching
  • rash
  • erythema
  • increased urination
  • difficulty urinating
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • increased hematocrit
  • urinary tract infections
  • vulvovaginal infections
  • balanitis
  • and other genital infections
  • fluid volume decrease
  • headache
  • dizziness
  • insomnia
  • fever
  • chest pain.

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture. It should be kept at room temperature between 1°C and 30°C. Storing it this way will help maintain the drug's effect and safety over time.

Appearance and packaging

Appearance

Pale yellow rectangular 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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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.