Medication info

Empagliflozin/Metformin Extended-Release Tablet 12.5/750 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Metformin Hydrochloride with Colloidal Anhydrous Silica›757.5mg / 1 tabletEmpagliflozin›12.5mg / 1 tablet
Manufacturer / importer
대원제약(주)
Appearance
Pink oval extended-release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202501912 · Approved 2025.07.25

Summary

Main use
Effect on blood sugar control and prevention of cardiovascular events in adults with type 2 diabetes
Who takes it
Adults
Adult dose
The dosage of this medication is based on a maximum of 25 mg of Empagliflozin and 2000 mg of extended-release Metformin Hydrochloride per day, taking into consideration the patient's treatment regimen, effectiveness, and tolerance. This medication is to be taken once daily at dinner to minimize gastrointestinal side effects associated with Metformin. The extended-release 10/1000 mg or 25/1000 mg formulations are to be taken once daily for 1 tablet.

Ingredients

Manufacturer
대원제약(주)

Efficacy & effects

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

View approved original text

This medication is used to assist in blood sugar control for adult patients with type 2 diabetes when used in conjunction with Empagliflozin and Metformin as adjunct therapy to diet and exercise. It is particularly effective for patients who do not achieve sufficient blood sugar control, and should be used under the guidance of a specialist in cases of cardiovascular disease. This medication is effective in improving blood sugar levels and assisting in diabetes management.

How to take

Adult dose

The dosage of this medication is based on a maximum of 25 mg of Empagliflozin and 2000 mg of extended-release Metformin Hydrochloride per day, taking into consideration the patient's treatment regimen, effectiveness, and tolerance. This medication is to be taken once daily at dinner to minimize gastrointestinal side effects associated with Metformin. The extended-release 10/1000 mg or 25/1000 mg formulations are to be taken once daily for 1 tablet.

Precautions

This medication consists of two components, Metformin and Empagliflozin, and is primarily used in the treatment of type 2 diabetes. While taking this medication, there is a rare possibility of serious lactic acidosis occurring, so caution is particularly necessary for patients with impaired kidney function or those with heart or liver disease. When used with other diabetes medications, hypoglycemic symptoms may occur, so blood sugar levels should be closely monitored. This medication should not be used in patients with moderate to severe impairment of kidney function, acute kidney injury, dehydration, severe infection, or heart failure. It should be temporarily discontinued before any examination involving iodine contrast agents, and administration should be resumed only after confirming that kidney function has returned to normal post-examination. Pregnant women or women who may become pregnant, as well as nursing mothers, should avoid using this medication. This medication may increase the risk of genital and urinary tract infections, so immediate consultation with healthcare professionals is required if any signs of infection appear. From the time of use, if symptoms such as hypoglycemia, abdominal pain, muscle pain, difficulty breathing, weakness, or other adverse effects occur, the patient should inform a physician immediately. Elderly patients or those with compromised kidney function should regularly have their kidney function evaluated, and dose adjustments should be made if necessary. It is advisable to avoid alcohol consumption while using this medication, and this medication may be temporarily paused in case of dehydration, diarrhea, or vomiting. This medication should be swallowed whole and should not be chewed or broken, although the tablet shell may be excreted in the stool, which is normal. If there are other medications being used concurrently, there may be potential for drug interactions, so all medications being taken should be disclosed to healthcare personnel. In the case of overdose, serious side effects such as lactic acidosis may occur, necessitating immediate treatment at a hospital.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • perineal necrosis
  • ketoacidosis
  • lactic acidosis
  • pyelonephritis
  • urinary sepsis
  • acute kidney injury
  • myocardial infarction
  • cerebral infarction
Show 11 more
  • acute cholecystitis
  • autoimmune hepatitis
  • cholelithiasis
  • shock
  • cardiopulmonary disease
  • sepsis
  • severe allergic reactions
  • severe skin reactions
  • severe neurological symptoms
  • liver abnormalities (jaundice)
  • severe edema or urinary disturbances

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
  • hepatitis
  • altered taste
  • itching
  • rash
  • erythema
  • thirst
  • increased serum lipids
  • increased blood creatinine
  • increased hematocrit
  • decreased vitamin B12
  • decreased fluid volume
  • dizziness
  • headache
  • fatigue
  • peripheral edema
  • facial swelling
  • generalized edema
  • weight loss
  • insomnia
  • chest discomfort
  • chest pain
  • drowsiness

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 from air and moisture, at a cool room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink oval 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.