Medication info
Empagliflozin and Metformin Extended-Release Tablets 25/1000 mg

Empagliflozin and Metformin Extended-Release Tablets 25/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Metformin Hydrochloride›1000mg / 1 tabletEmpagliflozin›25mg / 1 tablet
Manufacturer / importer
동화약품(주)
Appearance
Pale yellow, double convex, oval-shaped extended-release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202500993 · Approved 2025.04.24 · Insurance code 642707830

Summary

Main use
Effect on blood sugar control and prevention of cardiovascular events in type 2 diabetes
Who takes it
Adults
Adult dose
The dosage of this medication is determined within the range of a maximum daily dose of 25 mg of Empagliflozin and 2000 mg of extended-release Metformin Hydrochloride, considering each patient's current treatment, efficacy, and tolerability. This medication is taken once daily in the evening with meals to reduce gastrointestinal side effects associated with Metformin. Increases in Metformin Hydrochloride dosage should proceed gradually, while maintaining the extended-release characteristics.

Ingredients

Manufacturer
동화약품(주)

Efficacy & effects

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

  • Difficulty in blood sugar control
  • type 2 diabetes
  • cardiovascular diseases
View approved original text

This medication helps control blood sugar levels in adults with type 2 diabetes by combining Empagliflozin and Metformin. It is used alongside dietary and exercise regimens to effectively improve blood glucose levels. It is especially suitable for patients whose blood sugar control is inadequate, and extra care is needed in patients with cardiovascular diseases. This medication plays an important role in managing blood sugar control and cardiovascular health.

How to take

Adult dose

The dosage of this medication is determined within the range of a maximum daily dose of 25 mg of Empagliflozin and 2000 mg of extended-release Metformin Hydrochloride, considering each patient's current treatment, efficacy, and tolerability. This medication is taken once daily in the evening with meals to reduce gastrointestinal side effects associated with Metformin. Increases in Metformin Hydrochloride dosage should proceed gradually, while maintaining the extended-release characteristics.

Precautions

This medication is used for the treatment of diabetes and works by combining two main ingredients to help control blood sugar levels. However, caution is necessary while taking this medication. Severe lactic acidosis, a rare side effect, may occur, which can be life-threatening, so any symptoms must be reported to healthcare professionals immediately. Also, when taken with insulin or other diabetes medications, hypoglycemia may occur, so blood sugar levels must be monitored carefully. Patients with poor kidney function or those suffering from acute infections, serious heart issues, or liver dysfunction should avoid using this medication. Particularly, this medication should be temporarily discontinued before and after surgeries or imaging exams requiring iodinated contrast, and it should only be resumed once kidney function is verified to be normal. This medication may increase the risk of genital and urinary tract infections, so immediate treatment is necessary if symptoms appear. Additionally, this medication can lower Vitamin B12 levels, so long-term users should check their Vitamin B12 status with blood tests. Alcohol consumption should be avoided during treatment, particularly in patients with liver or kidney problems or dehydration. Elderly patients or those with reduced kidney function may need to adjust their medication dosage and regularly monitor kidney function. This medication should not be broken, chewed, or crushed; it must be swallowed whole, and there is no need to worry if the tablet's coating is expelled intact in stool. Serious side effects can occur in case of overdose; hence, the medication should be taken precisely as directed by a physician, and any suspected side effects should be discussed with a healthcare provider immediately. Finally, it is crucial to have regular blood tests and consultations with healthcare providers to continuously monitor health conditions while taking this medication.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, shedding skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, cough with fever and difficulty breathing, yellowing of skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, vision disturbances, paralysis, 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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  • abnormalities in liver function tests
  • hepatitis
  • taste disturbance
  • itching
  • rash
  • hives
  • erythema
  • angioedema
  • interstitial nephritis
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
  • increased hematocrit
  • decreased and deficiency of Vitamin B12
  • headache
  • dizziness
  • postural dizziness
  • drowsiness

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

Storage

This medication must be stored in a tightly closed container to protect it from air and moisture. It's essential to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the medication's efficacy and safety over time.

Appearance and packaging

Appearance

Pale yellow, double convex, 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.