Medication info
Empagliflozin/Metformin Hydrochloride 5/850 mg Tablet

Empagliflozin/Metformin Hydrochloride 5/850 mg Tablet

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
한림제약(주)
Appearance
Yellowish-white, convex oval film-coated tablet
Packaging
60 tablets/bottle, 60 tablets/box [10 tablets/PTP x 6]
Approval status
Active

MFDS item code 202501689 · Approved 2025.07.08 · Insurance code 645307210

Summary

Main use
Effectiveness in controlling blood sugar and preventing cardiovascular events in adult type 2 diabetes
Who takes it
Adults
Adult dose
The recommended dose of this medication is 1 tablet at a time, taken twice a day. The dosage should not exceed the maximum recommended daily dose of empagliflozin 25 mg and metformin 2000 mg per day. For patients using metformin alone or in combination with other medications such as insulin, the recommended dose is 5 mg of empagliflozin twice daily (total 10 mg) and the current dose of metformin. In cases where tolerance is good and additional blood sugar control is needed, the dose may be increased to 25 mg of empagliflozin (total per day).

Ingredients

Manufacturer
한림제약(주)

Efficacy & effects

Effectiveness in controlling blood sugar and preventing cardiovascular events in adult type 2 diabetes

  • Abnormal blood sugar regulation
  • type 2 diabetes
  • cardiovascular disease
View approved original text

This medication is used to enhance blood sugar control in adult patients with type 2 diabetes, in combination with dietary and exercise regimens, through the co-administration of empagliflozin and metformin. It may be used cautiously in adults with type 2 diabetes who have cardiovascular disease, especially when blood sugar is not adequately controlled. This medication not only assists in blood sugar control but also evaluates its impact on the risk of cardiovascular events based on clinical trial information from experts. Therefore, this medication helps to effectively manage blood sugar and improve cardiovascular health in patients with type 2 diabetes.

How to take

Adult dose

The recommended dose of this medication is 1 tablet at a time, taken twice a day. The dosage should not exceed the maximum recommended daily dose of empagliflozin 25 mg and metformin 2000 mg per day. For patients using metformin alone or in combination with other medications such as insulin, the recommended dose is 5 mg of empagliflozin twice daily (total 10 mg) and the current dose of metformin. In cases where tolerance is good and additional blood sugar control is needed, the dose may be increased to 25 mg of empagliflozin (total per day).

Precautions

This medication is used for the treatment of diabetes, with two active ingredients working together to help control blood sugar. Before taking this medication, it is essential to confirm that kidney function is normal. This medication should not be taken if kidney function is impaired. The medication should be temporarily suspended in cases of severe infection, dehydration, acute heart issues, or severe illness. It is safer not to take this medication during pregnancy or while breastfeeding. This medication can cause hypoglycemia, so if used in conjunction with insulin or other blood sugar-lowering agents, blood sugar levels should be monitored diligently. There is a rare but serious risk of lactic acidosis during treatment; if symptoms like vomiting, abdominal pain, muscle pain, or difficulty breathing occur, consult healthcare professionals immediately. Due to the increased risk of urinary tract infections or genital infections, prompt treatment is necessary if signs of infection appear. If symptoms of fluid loss or dehydration occur, it may be necessary to temporarily stop taking this medication. Patients with poor liver function should also use this medication with caution; it is advisable not to use it if there is liver disease. Regular blood tests and kidney function monitoring are required during treatment, especially for the elderly or patients with impaired kidney function. Alcohol intake may increase the risk of side effects; it is best to avoid drinking while taking this medication. If surgery is planned, suspend this medication 48 hours before the procedure and do not resume until kidney function has normalized post-surgery. This medication may interact with other drugs; inform healthcare professionals if you are taking any other medications. This medication is not recommended for children or adolescents under 18 as safety and effectiveness have not been established. If any adverse reactions or discomfort occur while taking this medication, consult a physician or pharmacist immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, lactic acidosis, ketoacidosis, urosepsis, pyelonephritis, perineal necrosis, liver dysfunction (hepatitis, acute cholecystitis, autoimmune hepatitis), severe skin reactions (severe rash, blistering, skin peeling, oral/ocular mucosal pain), difficulty breathing, asthma attacks, severe respiratory distress, severe skin reactions with high fever, jaundice, sudden and severe headache, cerebral infarction

Mild side effects

Nausea, vomiting, diarrhea, abdominal pain, loss of appetite, constipation, decreased and deficiency of vitamin B12, hypoglycemia (in case of combination with insulin and/or sulfonylureas), urinary tract infection, genital infection, increased urination, itching, rash, erythema, altered taste, thirst, increased serum lipids, increased serum creatinine, headache, dizziness, weakness, chest discomfort, fever, insomnia, weight loss, constipation, dyspepsia, vulvar pruritus, cough, allergies

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

Storage

This medication should be stored in a tightly closed container that is protected from air and moisture at room temperature between 1°C and 30°C. This will help maintain the effectiveness of the medication and prevent deterioration.

Appearance and packaging

Appearance

Yellowish-white, convex oval film-coated tablet

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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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.