Medication info
Empagrom 5/1000 mg (Empagliflozin, Metformin Hydrochloride)

Empagrom 5/1000 mg (Empagliflozin, Metformin Hydrochloride)

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

MFDS item code 202501690 · Approved 2025.07.08 · Insurance code 645307220

Summary

Main use
Effectiveness in controlling blood sugar in type 2 diabetes and preventing cardiovascular events
Who takes it
Adults
Adult dose
The recommended dose of this medication is 1 tablet, taken twice daily. The dosage should be determined considering each patient's treatment regimen, efficacy, and tolerability, not exceeding the limit of Empagliflozin 25 mg and Metformin 2000 mg. In cases where blood sugar control is insufficient with monotherapy of Metformin or in combination with other drugs like insulin, a recommended dosage of Empagliflozin 5 mg twice a day (total of 10 mg) with the existing Metformin dosage is suggested.

Ingredients

Manufacturer
한림제약(주)

Efficacy & effects

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

  • Blood sugar control problems in adult patients with type 2 diabetes
  • poor blood sugar control
  • cardiovascular diseases
View approved original text

This medication is used to assist in controlling blood sugar levels in adult patients with type 2 diabetes by combining Empagliflozin and Metformin. It is suitable for patients who follow dietary and exercise therapies, especially those whose blood sugar is not adequately controlled. It is also used cautiously in type 2 diabetes patients with cardiovascular disease. This medication improves blood sugar control and helps in diabetes management.

How to take

Adult dose

The recommended dose of this medication is 1 tablet, taken twice daily. The dosage should be determined considering each patient's treatment regimen, efficacy, and tolerability, not exceeding the limit of Empagliflozin 25 mg and Metformin 2000 mg. In cases where blood sugar control is insufficient with monotherapy of Metformin or in combination with other drugs like insulin, a recommended dosage of Empagliflozin 5 mg twice a day (total of 10 mg) with the existing Metformin dosage is suggested.

Precautions

This medication is used to control blood sugar as a diabetes treatment. While taking this medication, special attention should be paid due to the risk of a rare side effect called lactic acidosis. Lactic acidosis is a dangerous condition caused by the excessive accumulation of lactate in the body, which can sometimes be life-threatening. Additionally, caution is advised when taking this medication alongside insulin or sulfonylureas, as it may increase the risk of hypoglycemia, meaning that blood sugar could drop too low. This medication should not be used in patients with severely impaired renal function or in conditions such as acute infection, dehydration, heart failure, or acute myocardial infarction. If iodine contrast agents are used for examinations, this medication should be discontinued for a certain period before and after the examination and resumed only after confirming that kidney function is normal. Women who are pregnant or breastfeeding are advised not to take this medication. This medication can cause fluid loss, so it is important to be cautious about dehydration or low blood pressure, especially in elderly patients or those with cardiovascular disease. While on this medication, the risk of urinary tract infections or genital infections may increase, so if any signs of infection appear, contact medical personnel immediately. The Metformin component may lower vitamin B12 levels, so if taken long-term, it is advisable to regularly check vitamin B12 levels. Furthermore, it is important to avoid excessive alcohol consumption while on this medication, and if symptoms of hypoglycemia, lactic acidosis, or ketoacidosis appear, immediate medical attention should be sought. If preparing for surgery or unable to eat properly due to an acute illness, this medication should be temporarily stopped, and consultation with a doctor is necessary. This medication is not recommended for children, and elderly patients need appropriate dose adjustment with kidney function monitoring. In case of overdose, immediate medical attention is required, and blood dialysis may be necessary. Keep this medication out of reach of children and store it in its original container for safety.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • difficulty breathing
  • lactic acidosis
  • ketoacidosis
  • perineal necrosis
  • urosepsis
  • pyelonephritis
  • acute kidney injury
  • hepatitis
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  • biliary tract disorders
  • myocardial infarction
  • cerebrovascular accident
  • concussion
  • vascular stent thrombosis
  • vascular stent stenosis
  • sepsis
  • shock
  • acute cholecystitis
  • autoimmune hepatitis
  • cholelithiasis
  • renal failure
  • altered consciousness
  • paralysis
  • visual disturbances
  • thunderclap headache
  • seizures
  • severe rash
  • blisters
  • skin peeling.

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
  • rash
  • itching
  • urticaria
  • erythema
  • angioedema
  • increased serum lipids
  • elevated serum creatinine
  • decreased glomerular filtration rate
  • vitamin B12 decreases and deficiency
  • thirst
  • headache
  • dizziness
  • weakness
  • chest discomfort
  • chest pain
  • upper respiratory tract infections
  • nasopharyngitis
  • weight loss

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

Storage

Store this medication in a tightly sealed container to protect it from air and moisture. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Brownish-yellow, bilaterally convex, oval-shaped 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.