Medication info

Empagliflozin/Metformin Extended-Release Tablet 5/1000 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Metformin Hydrochloride with Colloidal Anhydrous Silica›1010mg / 1 tabletEmpagliflozin›5mg / 1 tablet
Manufacturer / importer
대원제약(주)
Appearance
Pale yellow oval extended-release film-coated tablet
Packaging
30 tablets per bottle
Approval status
Active

MFDS item code 202501911 · Approved 2025.07.25

Summary

Main use
Blood glucose control in adults with type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
In antidiabetic therapy, the dosage of this medication is determined based on each component's maximum recommended daily dose of Empagliflozin 25 mg and extended-release Metformin Hydrochloride 2000 mg, considering each patient's current therapeutic regimen, efficacy, and tolerability. This medication is taken once daily in the evening with meals to reduce gastrointestinal adverse reactions related to Metformin. This medication is 10/1000 mg extended-release.

Ingredients

Manufacturer
대원제약(주)

Efficacy & effects

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

  • Blood glucose control issues in patients with type 2 diabetes
  • poor blood glucose control
  • cardiovascular disease
View approved original text

This medication is used in combination with dietary and exercise regimens to help control blood sugar in adults with type 2 diabetes. It is particularly used in patients with cardiovascular diseases among those whose blood sugar control is inadequate. For precautions related to the occurrence of cardiovascular events, please refer to professional information. In summary, this drug is used to enhance blood glucose control in patients with type 2 diabetes.

How to take

Adult dose

In antidiabetic therapy, the dosage of this medication is determined based on each component's maximum recommended daily dose of Empagliflozin 25 mg and extended-release Metformin Hydrochloride 2000 mg, considering each patient's current therapeutic regimen, efficacy, and tolerability. This medication is taken once daily in the evening with meals to reduce gastrointestinal adverse reactions related to Metformin. This medication is 10/1000 mg extended-release.

Precautions

This medication helps control blood sugar levels. However, there are several important points to be aware of when using it. First, this medication can rarely cause a serious condition called lactic acidosis. Lactic acidosis can build up excessive lactate in the body, becoming dangerous, so if any unusual symptoms or discomfort occur while taking this drug, consult your doctor immediately. Second, hypoglycemia may occur when used with other diabetes medications, so caution is needed, especially when combined with insulin or sulfonylureas. Third, patients with poor kidney function, acute kidney disease, cardiovascular diseases such as heart failure or acute myocardial infarction, and those with liver dysfunction should not use this medication. Fourth, this medication should be temporarily discontinued before and after tests using iodine contrast agents, and should be resumed only after normal kidney function is confirmed. Fifth, patients about to undergo surgery should stop taking this medication 48 hours before surgery and resume only after confirming normal renal function post-surgery. Sixth, this medication may cause fluid volume loss; therefore, special caution is required when symptoms such as dehydration, diarrhea, or vomiting occur. Seventh, women who are pregnant or may become pregnant should avoid this medication, and it should also be avoided while breastfeeding. Eighth, elderly patients or those with impaired kidney function should consult with a doctor before taking this medication and should undergo regular kidney function tests. Ninth, avoiding alcohol consumption during treatment with this medication is advisable, as alcohol can increase the risk of lactic acidosis. Finally, this medication is in a swallowable tablet form and should not be crushed or chewed, but swallowed whole. Sometimes, the tablet coating may be excreted in the stool, but this is normal. If any unusual symptoms occur while taking this medication or if there are any concerns, it is essential to consult healthcare professionals for appropriate action.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • necrotizing fasciitis
  • ketoacidosis
  • lactic acidosis
  • urosepsis
  • pyelonephritis
  • myocardial infarction
  • cerebral infarction
  • liver damage
Show 14 more
  • acute kidney injury
  • acute cholecystitis
  • autoimmune hepatitis
  • cholelithiasis
  • cervicitis
  • severe edema
  • heart failure
  • severe allergic reactions
  • severe skin adverse reactions
  • respiratory issues
  • liver abnormalities
  • severe neurological symptoms
  • severe edema
  • or abnormal 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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  • abnormal liver function tests
  • hepatitis
  • dysgeusia
  • itching
  • rash
  • erythema
  • thirst
  • increased serum lipids
  • elevated serum creatinine
  • decreased glomerular filtration rate
  • increased hematocrit
  • decrease and deficiency of vitamin B12
  • headache
  • dizziness
  • orthostatic dizziness
  • drowsiness
  • fatigue
  • peripheral edema
  • facial edema
  • edema
  • weight

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 exposure to air and light. It is important to maintain storage temperatures between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Pale yellow oval extended-release film-coated tablet

Package unit

30 tablets per 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.