Medication info
Empagliflozin and Metformin Extended-Release Tablets 5/1000 mg (Empagliflozin, Metformin)

Empagliflozin and Metformin Extended-Release Tablets 5/1000 mg (Empagliflozin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
Pale pink oval-shaped extended-release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202501902 · Approved 2025.07.24 · Insurance code 643508980

Summary

Main use
Blood sugar control in adults with type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
This medication should be taken once daily in the evening with meals to reduce gastrointestinal adverse reactions associated with metformin. The extended-release formulations of this medication 10/1000 mg or 25/1000 mg should be taken once daily, with one tablet per dose. Patients taking the extended-release 5/1000 mg or 12.5/1000 mg should take two tablets simultaneously once daily. Regarding the use of metformin.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Blood sugar control in adults with type 2 diabetes and prevention of cardiovascular events

View approved original text

This medication is used to improve blood sugar control in patients with type 2 diabetes by combining empagliflozin and metformin. It is effective for adult patients whose blood sugar is not sufficiently controlled, when administered alongside dietary changes and exercise therapy. It is particularly used in patients with type 2 diabetes who have cardiovascular disease, and reference should be made to expert guidelines regarding related cardiovascular events. This medication is actively used to aid in the management of diabetes and improve blood sugar control.

How to take

Adult dose

This medication should be taken once daily in the evening with meals to reduce gastrointestinal adverse reactions associated with metformin. The extended-release formulations of this medication 10/1000 mg or 25/1000 mg should be taken once daily, with one tablet per dose. Patients taking the extended-release 5/1000 mg or 12.5/1000 mg should take two tablets simultaneously once daily. Regarding the use of metformin.

Precautions

This medication is used in the treatment of diabetes and works with two components to control blood sugar. Rare but serious side effects such as lactic acidosis may occur while taking this medication, so caution is advised, especially in patients with impaired renal function or cardiovascular disease. Additionally, taking this medication with insulin or sulfonylureas may increase the risk of hypoglycemia, so blood sugar levels must be monitored closely. Patients with moderate to severe renal impairment, acute renal problems, severe infections, heart failure, or acute myocardial infarction should not use this medication. Before and after tests using iodinated contrast agents, the intake of this medication should be temporarily suspended due to the risk of renal function deterioration and lactic acidosis, resuming only after renal function is confirmed to be normal. It is also advised that women who are pregnant or may become pregnant, patients with severely impaired liver function, and those in significantly poor nutritional status should avoid using this medication. While taking this medication, side effects such as hypoglycemia, urinary tract infections, genital infections, increased urination, gastrointestinal disorders (nausea, vomiting, diarrhea, etc.), hepatic dysfunction, skin rash, and others may occur, and any abnormal symptoms should be discussed with a healthcare provider. Particularly, elderly patients or those at risk of fluid loss should pay attention to dehydration or hypotension and must have their renal function regularly examined. Taking this medication along with alcohol increases the risk of lactic acidosis, so alcohol consumption should be avoided. The tablets should be swallowed whole and not chewed or crushed; the tablet coating may appear in stool but this is normal. It is important to regularly check blood sugar control and to consult a healthcare provider regarding potential drug interactions when combining this medication with others. In case of overdose, immediate hospital care should be sought, and rapid medical intervention is necessary if lactic acidosis is suspected.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • perineal necrosis
  • ketoacidosis
  • lactic acidosis
  • sepsis
  • acute pyelonephritis
  • pyelonephritis
  • renal failure
  • acute kidney injury
Show 17 more
  • cerebral infarction
  • myocardial infarction
  • severe edema
  • elevated blood pressure
  • severe allergic reactions
  • severe hypoglycemia
  • serious skin reaction
  • respiratory distress
  • severe neurological symptoms
  • jaundice
  • chest tightness
  • difficulty breathing
  • cold sweat
  • pallor
  • fever with severe rash
  • blisters
  • skin peeling.

Mild side effects

Hypoglycemia, urinary tract infections, genital infections, increased urination, nausea, vomiting, diarrhea, abdominal pain, loss of appetite, constipation, abnormal liver function tests, hepatitis, altered taste, itching, rash, erythema, increased serum lipids, elevated blood creatinine, thirst, elevated blood creatinine / decreased glomerular filtration rate, decreased vitamin B12 and deficiency, decreased fluid volume, weight loss, dizziness, headache, chest discomfort, chest pain, weakness, insomnia, postural hypotension.

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture and kept at room temperature between 1 and 30 degrees Celsius. Proper storage can maintain the effectiveness of the medication and prevent deterioration.

Appearance and packaging

Appearance

Pale pink oval-shaped extended-release film-coated tablet

Package unit

30 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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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.