Medication info
Empagliflozin/Metformin Hydrochloride Tablet 5/500 mg

Empagliflozin/Metformin Hydrochloride Tablet 5/500 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
한림제약(주)
Appearance
Orange-yellow, biconvex, oval-shaped film-coated tablet
Packaging
60 tablets/box [10 tablets/PTP x 6], 60 tablets/bottle
Approval status
Active

MFDS item code 202501688 · Approved 2025.07.08 · Insurance code 645307200

Summary

Main use
Effect on blood sugar control and prevention of cardiovascular events in adult patients with type 2 diabetes
Who takes it
Adults
Adult dose
The recommended dosage for this medication is 1 tablet twice a day. The maximum recommended daily dosage for each component is 25 mg of empagliflozin and 2000 mg of metformin. For patients not achieving adequate blood sugar control with metformin alone or in combination with insulin or other medications, empagliflozin 5 mg twice daily (total daily dose 10 mg) alongside the existing metformin dosage is recommended. If tolerability is good and additional blood sugar control is needed, the empagliflozin dosage may be increased to 25 mg (total daily dose).

Ingredients

Manufacturer
한림제약(주)

Efficacy & effects

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

  • Difficulty in blood sugar control
  • type 2 diabetes
  • cardiovascular disease
View approved original text

This medication is taken in addition to diet and exercise to improve blood sugar control in adult patients with type 2 diabetes. It is particularly helpful in effectively lowering blood sugar in patients whose levels are not sufficiently controlled. In some patients with cardiovascular disease, it is important to consider the impact on the occurrence of cardiovascular events; thus, consulting a healthcare professional is essential. This medication is used to enhance overall blood sugar control and improve the patient's health status.

How to take

Adult dose

The recommended dosage for this medication is 1 tablet twice a day. The maximum recommended daily dosage for each component is 25 mg of empagliflozin and 2000 mg of metformin. For patients not achieving adequate blood sugar control with metformin alone or in combination with insulin or other medications, empagliflozin 5 mg twice daily (total daily dose 10 mg) alongside the existing metformin dosage is recommended. If tolerability is good and additional blood sugar control is needed, the empagliflozin dosage may be increased to 25 mg (total daily dose).

Precautions

This medication is used to help control blood sugar and is prescribed for diabetes treatment. However, it should not be used in patients with severely impaired kidney function, acute infections, dehydration, heart failure, or severe conditions such as acute myocardial infarction. Women who are pregnant or nursing should not take this medication. It can occasionally cause a rare and serious side effect known as lactic acidosis; if symptoms such as fatigue, muscle pain, difficulty breathing, or abdominal pain occur, contact a doctor immediately. When taken with insulin or other hypoglycemic agents, there may be a risk of hypoglycemia, so caution is necessary. Additionally, this medication may increase the risk of urinary or genital infections, so quick treatment should be sought if infection symptoms arise. Regular checks of kidney function and blood sugar levels during treatment are important to ensure there are no abnormalities. This medication should be temporarily discontinued when undergoing surgery or when using iodinated contrast agents, and it should be avoided if there is insufficient fluid intake or dehydration. Alcohol consumption may increase the risk of side effects from this medication, so it is advisable to avoid it. Caution should be exercised when using this medication in older adults or patients at risk for fluid loss, and regular monitoring of vitamin B12 levels is recommended. If uncomfortable symptoms or adverse reactions occur during the use of this medication, consult healthcare professionals immediately.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormality with coughing and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Hypoglycemia
  • urinary tract infection
  • genital infection
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • elevated liver function tests
  • hepatitis
  • taste disturbance
  • itching
  • rash
  • urticaria
  • angioedema
  • difficulty urinating
  • thirst
  • increased serum lipids
  • elevated serum creatinine
  • decreased glomerular filtration rate
  • decreased and deficiency of vitamin B12
  • reduced fluid volume
  • headache
  • dizziness
  • chest discomfort
  • chest pain
  • weakness
  • facial swelling

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain storage temperatures between 1 to 30 degrees Celsius to ensure the longevity of its efficacy and safety.

Appearance and packaging

Appearance

Orange-yellow, biconvex, oval-shaped film-coated tablet

Package unit

60 tablets/box [10 tablets/PTP x 6], 60 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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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.