Medication info
Empagliflozin and Metformin Hydrochloride Tablets 5/850 mg (Empagliflozin, Metformin Hydrochloride)

Empagliflozin and Metformin Hydrochloride Tablets 5/850 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
일동제약(주)
Appearance
Yellow-tinged white, double-convex oval film-coated tablet
Packaging
60 tablets/bottle, 60 tablets/box [10 tablets/PTP x 6]
Approval status
Active

MFDS item code 202501726 · Approved 2025.07.09 · Insurance code 642907060

Summary

Main use
Effect on blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dose of this medication is 1 tablet taken twice daily. It should be determined based on each patient's current treatment regimen, efficacy, and tolerability, not exceeding a total of 25 mg of empagliflozin and 2000 mg of metformin. For patients who cannot achieve sufficient blood sugar control with metformin alone or in combination with other medications such as insulin, the recommended dose is 5 mg of empagliflozin taken twice daily (a total of 10 mg per day).

Ingredients

Manufacturer
일동제약(주)

Efficacy & effects

Effect on blood sugar control in type 2 diabetes and prevention of cardiovascular events

  • Type 2 diabetes
  • abnormal blood sugar control
  • cardiovascular disease
View approved original text

This medication is used to improve blood sugar control in adult patients with type 2 diabetes in conjunction with diet and exercise. It can be used in particularly careful circumstances for adult patients with type 2 diabetes who do not achieve sufficient blood sugar control and also have cardiovascular disease. It is designed to assist in managing blood sugar levels and may have a positive effect on cardiovascular health, making it important to take under the guidance of a healthcare professional for safe use.

How to take

Adult dose

The recommended dose of this medication is 1 tablet taken twice daily. It should be determined based on each patient's current treatment regimen, efficacy, and tolerability, not exceeding a total of 25 mg of empagliflozin and 2000 mg of metformin. For patients who cannot achieve sufficient blood sugar control with metformin alone or in combination with other medications such as insulin, the recommended dose is 5 mg of empagliflozin taken twice daily (a total of 10 mg per day).

Precautions

This medication is used in the treatment of diabetes and helps lower blood sugar levels. It can cause a rare but serious side effect known as lactic acidosis; therefore, it should not be used by patients with poor kidney function or certain acute diseases. In addition, when used with other diabetes medications such as insulin or sulfonylureas, the risk of hypoglycemia may increase, so caution is advised. Patients with weakened kidney function or the elderly should regularly undergo kidney function tests, and if kidney function declines significantly, the use of this medication should be discontinued. During the use of this medication, if there is a sudden change in physical condition such as dehydration, severe infection, or surgery, it may be necessary to temporarily stop taking the medication. This medication may cause urinary tract infections or genital infections, so if symptoms of infection appear, immediate consultation with medical personnel is required. Gastrointestinal disturbances such as nausea, vomiting, and diarrhea may occur during use, and vitamin B12 deficiency may develop, so confirmation through blood tests may be necessary if needed. Women who are pregnant, potentially pregnant, or breastfeeding should not take this medication. Furthermore, alcohol consumption may increase the risk of side effects from this medication, so it is advisable to avoid it. This medication can cause water loss and drop in blood pressure, so caution is needed, especially for hypertensive patients or the elderly. If any unusual symptoms or suspected side effects occur during treatment, immediate consultation with a physician is recommended, and regular check-ups should be conducted for safe use.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (angioedema)
  • ketoacidosis
  • lactic acidosis
  • necrotizing fasciitis
  • pyelonephritis
  • urosepsis
  • acute kidney injury
  • cerebral infarction
  • myocardial infarction
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  • angina
  • deep vein thrombosis
  • acute cholecystitis
  • autoimmune hepatitis
  • cholelithiasis

Mild side effects

  • Hypoglycemia
  • urinary tract infection
  • genital infection
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • abnormal liver function tests
  • hepatitis
  • taste disturbance
  • itching
  • rash
  • erythema
  • increased serum creatinine
  • thirst
  • reduced and deficient vitamin B12
  • headache
  • dizziness
  • weakness
  • chest discomfort
  • urinary stones
  • weight loss
  • vulvar pruritus
  • insomnia
  • hypertension
  • anxiety
  • ear pain
  • orthostatic dizziness
  • anemia
  • hypothyroidism

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

Storage

This medication is prone to be affected by air or moisture, so it must be stored in a tightly sealed container. The storage temperature should ideally be maintained at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow-tinged white, double-convex oval film-coated tablet

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.