Medication info
Empagliflozin and Metformin Tablets 12.5/500 mg (Empagliflozin, Metformin Hydrochloride)

Empagliflozin and Metformin Tablets 12.5/500 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
한림제약(주)
Appearance
Biconvex oval film-coated tablets with a light brownish-purple color
Packaging
60 tablets/bottle, 60 tablets/box [10 tablets/PTP x 6]
Approval status
Active

MFDS item code 202501917 · Approved 2025.07.25 · Insurance code 645307250

Summary

Main use
Effectiveness in blood sugar control for type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosing for this medication is 1 tablet at a time, to be taken twice daily. The dosage is determined by considering each patient's treatment regimen, efficacy, and tolerability, without exceeding the daily maximum of 25 mg for empagliflozin and 2000 mg for metformin. - For patients who have difficulty controlling blood sugar with monotherapy of metformin or other drugs such as insulin, the recommended dosage is 5 mg of empagliflozin taken twice daily (total of 10 mg) along with the existing dose of metformin.

Ingredients

Manufacturer
한림제약(주)

Efficacy & effects

Effectiveness in blood sugar control for type 2 diabetes and prevention of cardiovascular events

  • Type 2 diabetes with difficulty in blood sugar control
View approved original text

This medication is used to improve blood sugar control in adults with type 2 diabetes when combined with dietary and exercise therapy through the co-administration of empagliflozin and metformin. Especially for patients whose blood sugar is not adequately controlled and who have cardiovascular disease, this medication may impact the occurrence of cardiovascular events, thus consulting professional guidelines is advised. This medication helps effectively improve blood sugar levels in patients.

How to take

Adult dose

The recommended dosing for this medication is 1 tablet at a time, to be taken twice daily. The dosage is determined by considering each patient's treatment regimen, efficacy, and tolerability, without exceeding the daily maximum of 25 mg for empagliflozin and 2000 mg for metformin. - For patients who have difficulty controlling blood sugar with monotherapy of metformin or other drugs such as insulin, the recommended dosage is 5 mg of empagliflozin taken twice daily (total of 10 mg) along with the existing dose of metformin.

Precautions

This medication is used to lower blood sugar, and caution is needed as it can cause rare side effects such as severe lactic acidosis. When used with other diabetes medications, there can be a risk of hypoglycemia, so monitoring blood sugar status is essential. Patients with poor kidney function, acute kidney problems, severe infections, heart failure, and certain health conditions should not use this medication. It should be temporarily discontinued before and after tests that use iodinated contrast agents, and can only be resumed once kidney function has returned to normal. Women who are pregnant or nursing are advised not to use this medication. This drug can cause fluid loss, so patients at risk of dehydration should use it cautiously, as should the elderly and patients with cardiovascular diseases. Genital and urinary tract infections may occur during use, so if symptoms arise, consult a doctor immediately. Due to a potential drop in vitamin B12 levels, regular testing may be required during long-term use. In case of overdose, serious side effects such as lactic acidosis may occur, so dosage must be strictly followed, and medical attention should be sought immediately if side effects occur. Alcohol consumption should be avoided during treatment, and caution is necessary after sudden decreases in food intake or intense exercise due to the risk of hypoglycemia. The medication should be discontinued for a period before and after surgery, and resumed only after confirming kidney function is normal. This medication is not recommended for children under 18, and in elderly patients, starting at the minimum dosage while regularly monitoring kidney function is advisable. During treatment, consult a physician regarding possible interactions with other medications.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by high fever, blisters, skin peeling, pain in oral/ocular mucosa, breathing difficulties or shortness of breath, asthma attacks, cough with fever and respiratory abnormalities, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, vision abnormalities, paralysis.

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
  • increased serum lipids
  • increased blood creatinine
  • increased hematocrit
  • decreased vitamin B12 and deficiency
  • thirst
  • weight loss observed in diagnostic tests
  • vulvar pruritus
  • insomnia
  • headache
  • dizziness
  • fatigue
  • fever
  • increased blood pressure
  • anxiety
  • orthostatic.

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. It is important to maintain storage temperatures between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Biconvex oval film-coated tablets with a light brownish-purple color

Package unit

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

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.