Medication info
Empavex Tablet 5/850 mg (Empagliflozin, Metformin Hydrochloride)

Empavex Tablet 5/850 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
(주)서울제약
Appearance
White, oval, biconvex film-coated tablets with a yellow tint
Packaging
60 tablets/bottle, 60 tablets/box [10 tablets/PTP x 6]
Approval status
Active

MFDS item code 202501668 · Approved 2025.07.04 · Insurance code 652904730

Summary

Main use
Blood sugar control in adult type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage is 1 tablet once, twice daily. The maximum recommended daily dose for each ingredient is 25 mg of empagliflozin and 2000 mg of metformin. For patients taking metformin alone or in combination with other medications like insulin, the recommended dosage is 5 mg of empagliflozin twice a day (10 mg total daily amount) along with the current metformin dosage. This applies in cases where good tolerability is observed but further blood sugar control is needed.

Ingredients

Manufacturer
(주)서울제약

Efficacy & effects

Blood sugar control in adult 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 in combination with empagliflozin and metformin to effectively enhance blood sugar control in adults with type 2 diabetes alongside dietary and exercise therapy. It is particularly suitable for adult patients whose blood sugar is not adequately controlled, and caution is needed for patients with confirmed cardiovascular diseases regarding the occurrence of cardiovascular events. Therefore, this medication helps improve blood sugar management and assists in the treatment of type 2 diabetes.

How to take

Adult dose

The recommended dosage is 1 tablet once, twice daily. The maximum recommended daily dose for each ingredient is 25 mg of empagliflozin and 2000 mg of metformin. For patients taking metformin alone or in combination with other medications like insulin, the recommended dosage is 5 mg of empagliflozin twice a day (10 mg total daily amount) along with the current metformin dosage. This applies in cases where good tolerability is observed but further blood sugar control is needed.

Precautions

This medication helps to control blood sugar levels. However, there is a risk of serious side effects such as lactic acidosis when taking this medication, so caution is necessary. Particularly, patients with impaired kidney function or those with severe infections or dehydration should be cautious as taking this medication may pose risks. Furthermore, patients with type 1 diabetes or those with acute metabolic acidosis should not use this medication. If undergoing surgery or procedures using iodine contrast agents, this medication should be temporarily discontinued. This medication may increase the risk of hypoglycemia when used in conjunction with other diabetes medications such as insulin or sulfonylureas. While taking this medication, regular monitoring of kidney function is required, and extra caution is necessary in cases of dehydration symptoms or gastrointestinal disturbances. This medication may increase the risk of urinary tract infections or genital infections, so if any infection symptoms arise, consultation with a physician is necessary. It is advisable for pregnant or breastfeeding women not to take this medication. Elderly patients or those with reduced kidney function require dose adjustment and regular monitoring. In case of overdose, seek medical attention immediately.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • perineal necrosis
  • ketoacidosis
  • lactic acidosis
  • severe lactic acidosis
  • severe allergic reactions
  • urosepsis
  • pyelonephritis
  • acute kidney injury
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  • acute cholecystitis
  • autoimmune hepatitis
  • hepatitis
  • liver abnormalities (jaundice)
  • perineal necrosis (Fournier's gangrene)
  • acute pyelonephritis
  • sepsis
  • kidney and urinary tract disorders
  • acute renal failure
  • severe edema or urination abnormalities
  • acute and unstable heart failure
  • severe skin reactions

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
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • increased hematocrit
  • decreased Vitamin B12 and deficiency
  • reduced fluid volume
  • headache
  • dizziness
  • insomnia
  • asthenia
  • chest discomfort
  • chest pain
  • weight loss
  • vulvar pruritus
  • hypertension

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 important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White, oval, biconvex film-coated tablets with a yellow tint

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.