Medication info
Empavex 12.5/850 mg (Empagliflozin, Metformin Hydrochloride)

Empavex 12.5/850 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
(주)서울제약
Appearance
A pinkish-white, biconvex, oval film-coated tablet
Packaging
60 tablets/bottle, 60 tablets/box [10 tablets/PTP x 6]
Approval status
Active

MFDS item code 202501701 · Approved 2025.07.08 · Insurance code 652904760

Summary

Main use
Improvement of adult Type 2 diabetes (blood sugar control, prevention of cardiovascular events)
Who takes it
Adults
Adult dose
The recommended dosage of this medication is 1 tablet per dose, twice a day. The decision should be made considering each patient's treatment regimen, efficacy, and tolerability without exceeding the maximum recommended daily dosage of Empagliflozin 25 mg and Metformin 2000 mg. Patients who have difficulty controlling blood sugar with monotherapy of Metformin or in combination with insulin or other medications are recommended to take 5 mg of Empagliflozin twice a day along with their existing dose of Metformin.

Ingredients

Manufacturer
(주)서울제약

Efficacy & effects

Improvement of adult Type 2 diabetes (blood sugar control, prevention of cardiovascular events)

View approved original text

This medication works by combining the two ingredients, Empagliflozin and Metformin, to supplement dietary and exercise therapy, assisting in blood sugar control for adults with Type 2 diabetes. It can be used, particularly for patients whose blood sugar is not adequately controlled and have cardiovascular disease; however, guidance from a specialist regarding related cardiovascular events must be followed. This medication effectively improves blood sugar control and aids in the treatment of Type 2 diabetes.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet per dose, twice a day. The decision should be made considering each patient's treatment regimen, efficacy, and tolerability without exceeding the maximum recommended daily dosage of Empagliflozin 25 mg and Metformin 2000 mg. Patients who have difficulty controlling blood sugar with monotherapy of Metformin or in combination with insulin or other medications are recommended to take 5 mg of Empagliflozin twice a day along with their existing dose of Metformin.

Precautions

This medication is used for the treatment of diabetes, helping to lower blood sugar. However, severe lactic acidosis, a rare side effect, can occur, necessitating caution. When used in conjunction with other diabetes treatments, there is a risk of hypoglycemia, so care should be taken. Patients with impaired kidney function or acute disease should not use this medication. Additionally, women who are pregnant or breastfeeding should not take this medication. Regular kidney function tests should be performed while taking this medication, and it may be temporarily discontinued during periods of dehydration, severe infection, or before and after surgery. Patients at risk of fluid loss or elderly patients should be especially cautious when using this medication. Side effects such as gastrointestinal disturbances, urinary tract infections, genital infections, increased urination may occur; if symptoms arise, consult a physician. Symptoms of hypoglycemia, where blood sugar levels drop too low, can also appear; it is advisable to eat regularly and avoid sudden exercise or drinking alcohol. This medication should be used cautiously in patients with liver dysfunction, as liver function abnormalities may occasionally occur. Furthermore, when undergoing tests involving iodinated contrast agents, this medication should be stopped before and after the tests, and resumed only after confirming normal kidney function. Alcohol intake should be avoided while taking this medication as it may increase the risk of lactic acidosis. Patients should ensure adequate fluid intake while taking this medication and report any unusual symptoms to medical personnel immediately.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (angioedema)
  • chest tightness
  • difficulty breathing
  • cold sweat
  • paleness
  • severe rash with fever
  • blisters
  • skin peeling
  • pain in oral/ocular mucosa
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  • jaundice (yellowing of skin or eyes)
  • extreme general malaise
  • sudden and severe headache
  • thunderclap headache
  • seizures
  • altered consciousness
  • visual disturbances
  • paralysis
  • significantly decreased urine output
  • severe general swelling and hypertension
  • ketoacidosis
  • miscarriage

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 disorder
  • itching
  • rash
  • erythema
  • thirst
  • vitamin B12 deficiency
  • increase in blood creatinine levels
  • decrease in glomerular filtration rate
  • fatigue
  • chest discomfort
  • headache
  • dizziness
  • orthostatic dizziness
  • insomnia
  • fatigue
  • peripheral edema
  • facial swelling
  • weight loss
  • weight gain
  • anxiety
  • diplopia

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 air or moisture from entering. It is best to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. This will help keep the medication effective for a longer period.

Appearance and packaging

Appearance

A pinkish-white, biconvex, 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.