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

Empamax M Tablet 12.5/850 mg (Empagliflozin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin L-Proline›15.7mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
(주)종근당
Appearance
A white, oval-shaped, bidirectional convex film-coated tablet with a pink tinge.
Packaging
60 tablets/box [10 tablets/Blister x 6], 30 tablets/bottle
Approval status
Active

MFDS item code 202107451 · Approved 2021.11.12 · Insurance code 643309930

Summary

Main use
Blood sugar control for type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dose of this medication is 1 tablet once twice daily. The dosage should be determined without exceeding the maximum recommended daily doses of empagliflozin 25 mg and metformin 2000 mg for each component. For patients failing to achieve adequate blood sugar control on metformin alone or in combination therapy with insulin or other medications, the recommended dose is 5 mg of empagliflozin twice daily (total daily dose 10 mg) and the existing metformin dose.

Ingredients

Manufacturer
(주)종근당

Efficacy & effects

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

  • Blood sugar control abnormalities
  • type 2 diabetes
  • cardiovascular diseases
View approved original text

This medication is used as an adjunct to dietary and exercise therapy to improve blood sugar control in adult patients with type 2 diabetes. It is particularly effective for patients whose blood sugar is not adequately controlled, and caution should be exercised if there are accompanying cardiovascular diseases in relation to relevant clinical information. When administered this way, it helps efficiently manage blood sugar levels while improving the overall health of the patient.

How to take

Adult dose

The recommended dose of this medication is 1 tablet once twice daily. The dosage should be determined without exceeding the maximum recommended daily doses of empagliflozin 25 mg and metformin 2000 mg for each component. For patients failing to achieve adequate blood sugar control on metformin alone or in combination therapy with insulin or other medications, the recommended dose is 5 mg of empagliflozin twice daily (total daily dose 10 mg) and the existing metformin dose.

Precautions

This medication consists of two components that help control blood sugar. During the course of taking this medication, a rare side effect called severe lactic acidosis may occur, so caution should be exercised, especially in patients with poor kidney function or problems with the heart or liver. Additionally, when taken in conjunction with insulin or other diabetes medications, hypoglycemic symptoms may appear, so blood sugar levels should be checked frequently. Patients with moderate to severe renal impairment or acute kidney problems, heart failure, severe infections, or those scheduled for surgery should not take this medication and should discontinue it before and after examinations using iodine contrast agents. Pregnant or breastfeeding women and patients with liver dysfunction should also avoid this medication. While taking this medication, side effects such as hypoglycemia, urinary tract infections, genital infections, increased urination, gastrointestinal disturbances (nausea, vomiting, diarrhea), abdominal pain, loss of appetite, constipation, abnormal liver function tests, hepatitis, altered taste, itching, rash, erythema, increased serum lipids, increased serum creatinine, thirst, hyponatremia, weight gain or loss, headache, dizziness, insomnia, anxiety, chest discomfort, weakness, facial swelling, fever, and blood pressure issues may occur, and any abnormal symptoms should be reported to a physician immediately. Particularly, patients at risk for dehydration or fluid loss should carefully monitor blood pressure and fluid status, and temporarily discontinue the medication if necessary. This medication may decrease vitamin B12 levels, so regular blood tests should be conducted during long-term use. Alcohol consumption can increase the risk of lactic acidosis, so it is important not to drink excessively while taking this medication. Moreover, there are several medications that may interact with this medication, so if you are taking other medications, be sure to inform your healthcare provider or pharmacist. Elderly individuals are at a higher risk of declining kidney function and require dosage adjustments and regular monitoring of kidney function. Serious side effects may occur in case of overdose, so immediate medical treatment should be sought. Store this medication out of reach of children and keep it in its original container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, perineal necrosis, ketoacidosis, lactic acidosis, severe allergic reactions, severe skin adverse reactions, liver abnormalities (jaundice), severe neurological symptoms (cerebral infarction, headache, seizures, etc.), severe edema or urinary changes (acute renal damage, pyelonephritis, urosepsis), chest tightness, difficulty breathing, cold sweat, pallor, acute cholecystitis, autoimmune hepatitis, cholelithiasis, acute renal failure, sepsis, shock,

Mild side effects

Hypoglycemia (when combined with sulfonylurea or insulin), urinary tract infection, genital infection, increased urination, nausea, vomiting, diarrhea, abdominal pain, loss of appetite, constipation, abnormal liver function tests, hepatitis, altered taste, itching, rash, erythema, increased serum lipids, increased serum creatinine, thirst, hyponatremia, weight gain or loss, headache, dizziness, insomnia, anxiety, chest discomfort, weakness, facial swelling, fever, blood pressure issues

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

Storage

This medication may be sensitive to air or humidity, so it must be stored in a sealed container. It is important to maintain the storage temperature between 1 degree and 30 degrees Celsius to safely preserve the efficacy of the medication over time.

Appearance and packaging

Appearance

A white, oval-shaped, bidirectional convex film-coated tablet with a pink tinge.

Package unit

60 tablets/box [10 tablets/Blister x 6], 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.