Medication info
Empagliflozin 2L-Proline/Metformin Film-Coated Tablets 12.5/850 mg

Empagliflozin 2L-Proline/Metformin Film-Coated Tablets 12.5/850 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin 2L-Proline›18.88mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
(주)경보제약
Appearance
Oval, film-coated tablet that is white with a pink tint
Packaging
30 tablets/bottle, 60 tablets/bottle
Approval status
Active

MFDS item code 202502937 · Approved 2025.11.13

Summary

Main use
Effectiveness in blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage of this medication is 1 tablet, twice a day. The dosage is determined considering each patient's treatment regimen, efficacy, and tolerability but should not exceed the maximum daily doses of empagliflozin 25 mg and metformin 2000 mg. For patients whose blood glucose is not sufficiently controlled with metformin alone or in combination therapy with insulin, a suggested dose is empagliflozin 5 mg twice a day (total of 10 mg daily) along with the existing dose of metformin.

Ingredients

Manufacturer
(주)경보제약

Efficacy & effects

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

  • Type 2 diabetes with poor blood sugar control
  • cardiovascular diseases
  • cardiovascular events
View approved original text

This medication contains empagliflozin and metformin, which work together to help control blood sugar levels in patients with type 2 diabetes more effectively. It is particularly effective when taken alongside dietary changes and exercise, and is used when blood sugar is not adequately controlled. It is also suitable for type 2 diabetes patients with cardiovascular diseases; for information related to cardiovascular events, refer to professional clinical trial documentation. This medication helps protect patients' health by improving blood sugar control.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet, twice a day. The dosage is determined considering each patient's treatment regimen, efficacy, and tolerability but should not exceed the maximum daily doses of empagliflozin 25 mg and metformin 2000 mg. For patients whose blood glucose is not sufficiently controlled with metformin alone or in combination therapy with insulin, a suggested dose is empagliflozin 5 mg twice a day (total of 10 mg daily) along with the existing dose of metformin.

Precautions

This medication helps manage blood sugar levels. However, it may cause severe lactic acidosis, a serious side effect, so if symptoms occur, medical attention should be sought immediately. Additionally, caution is needed when taken with insulin or other diabetes medications as hypoglycemia may occur. Patients with moderate to severe renal impairment, acute kidney issues, severe infections, heart failure, or acute myocardial infarction should not take this medication. Furthermore, this medication must be temporarily discontinued around tests involving iodine contrast agents, and should only be resumed once kidney function is confirmed to be normal. This medication is not recommended for pregnant or breastfeeding women. Elderly patients or those with reduced kidney function should take this medication while regularly monitoring kidney function through blood tests. During treatment, side effects such as urinary tract infections, genital infections, and increased urination may occur, so report any such symptoms to healthcare providers. Additionally, as this medication may cause fluid loss, caution is required in cases of dehydration or gastrointestinal disturbances. Hypoglycemic symptoms may occur, hence it is essential to eat regularly, and if taken with other blood sugar-lowering agents, to consult a physician for adjusting doses to lower hypoglycemic risks. Vitamin B12 levels may decrease; therefore, regular monitoring of vitamin B12 levels is advisable for long-term users. In cases of overdose, severe side effects such as lactic acidosis may occur, so it is essential to adhere strictly to the prescribed dose and medical advice. Finally, it is safest to avoid alcohol while taking this medication, and to consult healthcare providers immediately if any unusual symptoms arise.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, necrotizing fasciitis of the perineum (Fournier's gangrene), ketoacidosis, lactic acidosis, urosepsis, pyelonephritis, severe allergic reactions, severe skin adverse reactions, liver abnormalities (jaundice), serious neurological symptoms (headaches, strokes, concussions, confusion, seizures, paralysis), severe edema or urination abnormalities (severe generalized swelling accompanied by increased blood pressure), acute kidney injury, acute renal failure, acute cholecystitis, autoimmune conditions

Mild side effects

Nausea, vomiting, diarrhea, abdominal pain, loss of appetite, constipation, altered taste, itching, rash, erythema, thirst, increased serum lipids, hypoglycemia (when taken with insulin and sulfonylureas), urinary tract infections, genital infections, increased urination, urination difficulties, reduced and deficiency of vitamin B12, abnormal liver function tests, hepatitis, increased blood creatinine, reduced glomerular filtration rate, headaches, dizziness, orthostatic dizziness, memory disturbances, drowsiness, insomnia,

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

Storage

This medication should be stored in a closed container to protect it from air and moisture, preferably at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Oval, film-coated tablet that is white with a pink tint

Package unit

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.