Medication info
Empavex 5/1000 mg (empagliflozin, metformin hydrochloride)

Empavex 5/1000 mg (empagliflozin, metformin hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
(주)서울제약
Appearance
A yellow, brownish, double-convex, film-coated tablet.
Packaging
60 tablets/bottle, 60 tablets/box [10 tablets/PTP x 6]
Approval status
Active

MFDS item code 202501667 · Approved 2025.07.04 · Insurance code 652904720

Summary

Main use
Effectiveness in controlling blood sugar levels for type 2 diabetes and preventing cardiovascular events.
Who takes it
Adults
Adult dose
The recommended dose of this medication is 1 tablet per dose, taken twice daily. It is determined for each patient considering their therapeutic regimen, efficacy, and tolerability, without exceeding empagliflozin 25 mg and metformin 2000 mg per day. - When used alone with metformin or in combination with other drugs like insulin, the recommended dose is empagliflozin 5 mg taken twice daily (total daily dose of 10 mg) with the existing dose of metformin. - Excellent tolerability.

Ingredients

Manufacturer
(주)서울제약

Efficacy & effects

Effectiveness in controlling blood sugar levels for type 2 diabetes and preventing cardiovascular events.

  • Blood sugar control issues in adult type 2 diabetes patients
  • insufficient blood sugar control in adult type 2 diabetes
  • cardiovascular disease.
View approved original text

This medication is used as an adjunct to diet and exercise in adult patients with type 2 diabetes to improve blood sugar control. It is particularly suitable for patients whose blood sugar levels are not sufficiently controlled, and may be used under medical supervision in cases where cardiovascular disease is present. This assists in managing the risk of cardiovascular events while improving blood sugar control.

How to take

Adult dose

The recommended dose of this medication is 1 tablet per dose, taken twice daily. It is determined for each patient considering their therapeutic regimen, efficacy, and tolerability, without exceeding empagliflozin 25 mg and metformin 2000 mg per day. - When used alone with metformin or in combination with other drugs like insulin, the recommended dose is empagliflozin 5 mg taken twice daily (total daily dose of 10 mg) with the existing dose of metformin. - Excellent tolerability.

Precautions

This medication helps control blood sugar levels. Rare side effects such as severe lactic acidosis may occur during treatment. Caution is needed when used with other diabetes medications, as hypoglycemia may occur. Patients with moderate to severe renal impairment, acute kidney problems, severe infections, or heart failure should not take this medication. It should be temporarily discontinued prior to examinations using iodinated contrast agents and resumed only after normal kidney function is confirmed. It is also advisable to discontinue use for a certain period prior to surgery and to resume post-recovery. Patients who consume alcohol excessively or have impaired liver function should avoid using this medication. Women who are pregnant or breastfeeding should not use this medication. Regular kidney function tests should be conducted while on this medication, and any symptoms of hypoglycemia or infection should be reported to a healthcare provider immediately. This medication may increase the risk of urinary and genital infections, so prompt treatment is necessary if infection symptoms arise. Vitamin B12 levels may decrease; thus, a B12 test is recommended for prolonged use. Gastrointestinal disturbances such as dizziness, vomiting, diarrhea, and abdominal pain may occur, and if symptoms are severe, consultation with a physician is necessary. Elderly patients are at higher risk of renal impairment and should take special care during use. Blood sugar control should be regularly monitored during treatment, and proper measures must be taken in case of hypoglycemic symptoms. In case of overdose, immediate hospital visit for appropriate treatment is required, especially if symptoms of lactic acidosis arise, which need emergency treatment. Keep the medication out of reach of children and store it in its original container.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • severe swelling (edema)
  • ketosis
  • lactic acidosis
  • urosepsis
  • pyelonephritis
  • perineal necrosis
  • stroke
  • myocardial infarction
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  • acute kidney injury
  • hepatitis
  • liver dysfunction
  • cholelithiasis
  • cholecystitis
  • sepsis
  • asthma attacks
  • dyspnea
  • difficulty in breathing
  • severe allergic reactions
  • severe skin reactions
  • serious neurological symptoms
  • acute cholecystitis
  • autoimmune hepatitis
  • heart failure
  • ureteral calculi.

Mild side effects

  • Hypoglycemia
  • urinary tract infections
  • genital infections
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • abnormal liver function tests
  • altered taste
  • itching
  • rash
  • erythema
  • angioedema
  • thirst
  • increased serum creatinine
  • decreased glomerular filtration rate
  • decrease in vitamin B12
  • dizziness
  • headache
  • weakness
  • chest discomfort
  • chest pain
  • fatigue
  • fever
  • weight loss
  • vulvar itching
  • insomnia
  • anxiety.

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 exposure to air and moisture. It is recommended to maintain a room temperature between 1 degree and 30 degrees Celsius for safe storage of the medication's effectiveness.

Appearance and packaging

Appearance

A yellow, brownish, double-convex, 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.