Medication info
Empagliflozin/Metformin Tablet 12.5/850 mg (Empagliflozin, Metformin Hydrochloride)

Empagliflozin/Metformin Tablet 12.5/850 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
삼진제약(주)
Appearance
Pinkish-white, convex, oval-shaped film-coated tablet
Packaging
60 tablets/box [10 tablets/PTP x 6], 10 tablets/box [10 tablets/PTP x 1], 30 tablets/bottle, 60 tablets/bottle
Approval status
Active

MFDS item code 202302699 · Approved 2023.09.11 · Insurance code 647805820

Summary

Main use
Blood sugar control for type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage of this medication is 1 tablet once, twice a day. The dosage is determined considering each patient's current treatment regimen, efficacy, and tolerability, without exceeding the maximum recommended daily doses of Empagliflozin 25 mg and Metformin 2000 mg. In cases where sufficient blood sugar control cannot be achieved with metformin alone or in combination with other medications such as insulin, the recommended dosage is Empagliflozin

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Blood sugar control for type 2 diabetes and prevention of cardiovascular events

View approved original text

This medication is used in conjunction with dietary and exercise therapy to help adults with type 2 diabetes to control their blood sugar levels. It is particularly suitable for those whose blood sugar control is insufficient with other treatments, and may be used cautiously in patients with cardiovascular diseases. This medication helps to improve blood sugar management, thereby reducing the risk of diabetes-related complications.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet once, twice a day. The dosage is determined considering each patient's current treatment regimen, efficacy, and tolerability, without exceeding the maximum recommended daily doses of Empagliflozin 25 mg and Metformin 2000 mg. In cases where sufficient blood sugar control cannot be achieved with metformin alone or in combination with other medications such as insulin, the recommended dosage is Empagliflozin

Precautions

This medication contains two active ingredients for the treatment of diabetes. Caution is needed because a rare side effect called lactic acidosis may occur when taking this drug. Lactic acidosis is a condition characterized by increased levels of lactate in the blood, leading to acidity, which can be life-threatening if severe. When taken in combination with other diabetes medications, the risk of hypoglycemia may increase, thus careful monitoring of blood glucose levels is essential, especially when used alongside insulin or sulfonylureas. This medication should not be used in patients with moderate to severe renal impairment, acute renal problems, severe infections, heart failure, or acute myocardial infarction. Additionally, this medication should be discontinued prior to undergoing tests that use iodinated contrast agents and should not be resumed until renal function returns to normal. It is safer for women who are pregnant or may become pregnant, and women who are breastfeeding not to take this medication. This medication may cause fluid loss, so caution is required in cases of dehydration symptoms, diarrhea, or vomiting, especially in elderly patients or those with cardiovascular diseases. During treatment, urinary and genital infections may occur, so if signs of infection appear, medical consultation is immediately necessary. Since vitamin B12 levels may decrease, patients on long-term therapy should routinely have vitamin B12 levels checked. In the case of overdose, the risk of lactic acidosis increases, so strict adherence to dosing guidelines is essential, and immediate hospital treatment should be sought if overdose is suspected. The safety and efficacy of this medication have not been established in children, so it is not recommended for those under 18 years old. The effects on driving or operating machinery are unclear, so caution is advised after taking this medication. Finally, during the course of taking this medication, regular monitoring of renal function and blood glucose levels should be performed, and any abnormal symptoms should prompt immediate consultation with a healthcare provider.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • perineal necrosis
  • lactic acidosis
  • ketoacidosis
  • severe allergic reactions
  • severe skin reactions
  • difficulty breathing
  • liver abnormalities (jaundice)
  • severe neurological symptoms
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  • severe edema or urinary abnormalities
  • severe rash
  • blistering
  • skin peeling
  • mouth/eye mucosal pain
  • urosepsis
  • pyelonephritis
  • acute kidney injury
  • cerebral infarction
  • acute cholecystitis
  • autoimmune hepatitis
  • cholelithiasis
  • pneumonia
  • sepsis
  • myocardial infarction

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
  • altered taste
  • itching
  • rash
  • erythema
  • urticaria
  • angioedema
  • difficulty urinating
  • interstitial nephritis
  • thirst
  • increased serum lipids
  • elevated serum creatinine
  • increased hematocrit
  • decreased fluid volume
  • dizziness
  • headache
  • chest discomfort
  • chest pain
  • weakness
  • weight loss
  • vulvodynia

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is best to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Pinkish-white, convex, oval-shaped film-coated tablet

Package unit

60 tablets/box [10 tablets/PTP x 6], 10 tablets/box [10 tablets/PTP x 1], 30 tablets/bottle, 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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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.