Medication info
EmpaMax M Extended Release Tablet 12.5/1000 mg (Empagliflozin, Metformin)

EmpaMax M Extended Release Tablet 12.5/1000 mg (Empagliflozin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin L-Proline›15.69mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
(주)종근당
Appearance
Pink oval extended-release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202501901 · Approved 2025.07.24 · Insurance code 643310030

Summary

Main use
Effect on blood glucose control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The dosage of this medication is determined within the range of the maximum recommended daily doses for each ingredient: Empagliflozin 25 mg and extended-release Metformin Hydrochloride not exceeding 2000 mg, taking into consideration each patient's current treatment, efficacy, and tolerability. This medication is taken once daily in the evening with meals to reduce gastrointestinal adverse effects related to Metformin. This medication comes as 10/1000 mg, 25/1000 mg

Ingredients

Manufacturer
(주)종근당

Efficacy & effects

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

  • Blood glucose control issues in adult patients with type 2 diabetes
  • cardiovascular diseases
View approved original text

This medication is used as a combination of Empagliflozin and Metformin to help control blood glucose levels in adult patients with type 2 diabetes, supplementing dietary and exercise therapy. It is particularly administered to patients whose blood glucose is not adequately controlled, and caution is required in patients with cardiovascular diseases according to this information. This medication is effective in managing blood glucose and is used in diabetes treatment.

How to take

Adult dose

The dosage of this medication is determined within the range of the maximum recommended daily doses for each ingredient: Empagliflozin 25 mg and extended-release Metformin Hydrochloride not exceeding 2000 mg, taking into consideration each patient's current treatment, efficacy, and tolerability. This medication is taken once daily in the evening with meals to reduce gastrointestinal adverse effects related to Metformin. This medication comes as 10/1000 mg, 25/1000 mg

Precautions

This medication helps lower blood glucose levels, with the active ingredients being Empagliflozin and Metformin. Rarely, serious metabolic disorders such as lactic acidosis may occur while taking this medication, so immediate consultation with a doctor is necessary if symptoms arise. There is a risk of hypoglycemia when used with other diabetes medications, so caution is needed. Do not use this medication in patients with moderate to severe renal impairment or acute kidney issues. Specific conditions such as severe infections, dehydration, heart failure, pre-and post-surgery, liver dysfunction, or in pregnant women should avoid or use this medication with caution. Regular kidney function tests should be conducted before and during treatment, particularly for elderly or patients with diminished kidney function who may require more frequent testing. As there is a risk of hypoglycemia with this medication, dose adjustment may be necessary when combined with drugs like insulin or sulfonylureas. Urinary tract infections or genital infections may occur during treatment, so rapid treatment is necessary if symptoms arise. Due to the risk of hypotension or dehydration from fluid loss, caution is needed when dehydration symptoms or instability in fluid status are present. This medication may lower vitamin B12 levels, so monitoring vitamin B12 levels is recommended with prolonged use. Alcohol consumption may increase the risk of lactic acidosis, so it is advisable to avoid drinking while taking this medication. It is not safe to use this medication in pregnant or potentially pregnant women or breastfeeding women. It is not recommended for children as safety and efficacy have not been established. In case of overdose, lactic acidosis or other serious side effects may occur, so immediate medical attention is required. The tablets should be swallowed whole and not crushed or chewed, and it is normal for the tablet coating to be excreted. During treatment, regular blood tests and physical examinations should be conducted to monitor for adverse reactions, and consultation with medical personnel is required if any unusual symptoms occur.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with fever, blisters, skin peeling, mucosal pain in mouth/eyes, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory distress with cough + fever, jaundice (yellowing of skin or eyes), profound lethargy, liver issues (jaundice), sudden and severe

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • decreased appetite
  • constipation
  • altered taste
  • itching
  • rash
  • erythema
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  • hypoglycemia (mild and when combined)
  • urinary tract infection
  • genital infection
  • increased urination
  • increased serum creatinine
  • increased hematocrit
  • decreased and deficiency of vitamin B12
  • facial paralysis
  • headache
  • dizziness
  • orthostatic dizziness
  • fatigue
  • weakness
  • weight loss
  • constipation
  • insomnia
  • chest pain
  • cough
  • breathing difficulties
  • facial swelling
  • fever

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

Storage

Store this medication in a tightly sealed container to prevent exposure to air and moisture. It is best to keep it at room temperature, between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink oval 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.