Medication info
Empagliflozin/Metformin Extended-Release Tablets 25/1000 mg

Empagliflozin/Metformin Extended-Release Tablets 25/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›25mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
Brownish-red oval extended-release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202501759 · Approved 2025.07.11 · Insurance code 643508930

Summary

Main use
Blood sugar control in adult patients with type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
This medication is taken once daily in the evening with meals. The 10/1000 mg extended-release tablet or the 25/1000 mg extended-release tablet should be taken once daily as 1 tablet. The 5/1000 mg extended-release tablet or the 12.5/1000 mg extended-release tablet should be taken once daily as 2 tablets simultaneously. Increases in the dose of metformin hydrochloride should be made gradually, and this medication should not be crushed, broken, ground, or chewed.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

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

View approved original text

This medication helps improve blood sugar control in adult patients with type 2 diabetes through the combined use of empagliflozin and metformin. It can enhance treatment effectiveness when used in conjunction with a dietary and exercise regimen. Careful use is also necessary for type 2 diabetes patients with cardiovascular disease whose blood sugar is inadequately controlled. This medication is expected to have a positive effect on blood sugar control and cardiovascular risk management, making it useful for the treatment of type 2 diabetes.

How to take

Adult dose

This medication is taken once daily in the evening with meals. The 10/1000 mg extended-release tablet or the 25/1000 mg extended-release tablet should be taken once daily as 1 tablet. The 5/1000 mg extended-release tablet or the 12.5/1000 mg extended-release tablet should be taken once daily as 2 tablets simultaneously. Increases in the dose of metformin hydrochloride should be made gradually, and this medication should not be crushed, broken, ground, or chewed.

Precautions

This medication helps regulate blood sugar levels. However, during the use of this medication, there is a risk of a rare complication called lactic acidosis, which warrants caution. Lactic acidosis is a serious condition caused by excessive accumulation of lactic acid in the body, with symptoms including fatigue, muscle pain, difficulty breathing, and abdominal pain. Additionally, this medication may increase the risk of hypoglycemia when taken together with insulin or sulfonylureas, so blood sugar changes should be monitored closely. Patients with impaired kidney function, acute renal failure, dehydration, severe infections, or heart failure should not take this medication. Use of iodine contrast agents requires temporary discontinuation of this medication before and after the tests, and resumption should only occur after normal kidney function is confirmed. Women who are pregnant or may become pregnant are advised against taking this medication, and it should also be avoided during breastfeeding. This medication may increase the risk of genital and urinary tract infections; therefore, if infection symptoms appear, patients should consult their doctor immediately. Elderly patients or those at risk for fluid loss should be aware of dehydration and hypotension and undergo regular kidney function checks. It is advisable to avoid alcohol consumption during treatment and to watch for hypoglycemia after sudden dietary imbalances or intense physical activities. Patients taking this medication should report any unusual symptoms to healthcare professionals immediately and undergo appropriate examinations. The tablets should be swallowed whole without breaking or chewing, and it is normal for the tablet coating to appear in the stool. This medication may interact with other drugs, so if patients are taking any other medications, they must inform their doctor or pharmacist.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral or ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, significantly reduced urine output

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
  • altered taste
  • itching
  • rash
  • redness
Show 18 more
  • hypoglycemia
  • reduction and deficiency of vitamin B12
  • genital mycotic infections
  • vulvitis
  • balanitides and other genital infections
  • urinary tract infections
  • increased urination
  • difficulty urinating
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • elevated hematocrit
  • weight loss
  • vulvar pruritus
  • benign prostatic hyperplasia
  • headache
  • dizziness
  • insomnia

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly closed container. Additionally, it is recommended to store the medication at room temperature, between 1 to 30 degrees Celsius, avoiding excessively hot or cold conditions.

Appearance and packaging

Appearance

Brownish-red oval 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.