Medication info

Mglieduo Tablet 5/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
한국프라임제약(주)
Appearance
Brownish yellow, oval film-coated tablet with a convex shape on both sides
Packaging
10 tablets/box [10 tablets/PTP x 1], 60 tablets/box [10 tablets/PTP x 6], 60 tablets/bottle
Approval status
Active

MFDS item code 202201733 · Approved 2022.04.28

Summary

Main use
Effect on blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
Take 1 tablet per dose, twice a day. The dosage of empagliflozin and metformin should not exceed 25 mg and 2000 mg, respectively. For patients taking metformin alone or in combination with insulin or other medications, the recommended dose is 5 mg of empagliflozin twice a day, alongside the existing dosage of metformin. If tolerance is good and additional blood sugar control is necessary, the total daily dose of empagliflozin may be increased to 25 mg.

Ingredients

Manufacturer
한국프라임제약(주)

Efficacy & effects

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

  • Type 2 diabetes
  • blood sugar control abnormalities
  • cardiovascular disease
View approved original text

This medication is used in combination with dietary and exercise therapy to assist in blood sugar control in adult patients with type 2 diabetes through the combined administration of empagliflozin and metformin. In particular, in type 2 diabetes patients whose blood sugar control is inadequate and who have cardiovascular disease, the impact on the occurrence of cardiovascular events should refer to professional information. This medication helps to effectively manage blood sugar for diabetes treatment.

How to take

Adult dose

Take 1 tablet per dose, twice a day. The dosage of empagliflozin and metformin should not exceed 25 mg and 2000 mg, respectively. For patients taking metformin alone or in combination with insulin or other medications, the recommended dose is 5 mg of empagliflozin twice a day, alongside the existing dosage of metformin. If tolerance is good and additional blood sugar control is necessary, the total daily dose of empagliflozin may be increased to 25 mg.

Precautions

This medication aids in blood sugar control. However, caution is advised as it may cause a rare side effect called severe lactic acidosis. When used with other diabetes medications, there is a risk of hypoglycemia. Patients with moderate to severe renal impairment, acute renal issues, severe infection, or heart failure should not use this medication due to potential risks. It should be temporarily discontinued before and after tests using iodine contrast agents and can be restarted only after renal function is confirmed to be normal. Patients scheduled for surgery should also discontinue this medication 48 hours prior to surgery and wait until renal function returns to normal post-surgery. Pregnant women or those who may become pregnant, as well as nursing mothers, should not use this medication for safety reasons. This medication may be affected by renal function, therefore renal function should be monitored regularly during use. Additionally, irregular meals, intense exercise, and interactions with other medications may increase the risks of hypoglycemia or lactic acidosis, so caution is needed. This medication may lead to side effects such as urinary tract infections or genital infections, and symptoms should prompt consultation with a physician. Long-term use may cause vitamin B12 deficiency, hence blood tests are recommended to monitor this. Alcohol consumption may increase the risk of lactic acidosis, therefore excessive drinking should be avoided while taking this medication. In elderly patients, there is a higher risk of fluid loss, so enhanced caution is needed, along with dosage adjustments based on renal function. In case of overdose, it is essential to visit a medical institution immediately for appropriate treatment, which may include hemodialysis. This medication has not been established for safety and efficacy in children, hence is not recommended for those under 18 years of age. Lastly, this medication should be stored out of reach of children and kept in its original container.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • angioedema
  • ketoacidosis
  • lactic acidosis
  • severe allergic reactions
  • severe skin adverse reactions
  • perineal necrosis
  • vascular stent thrombosis
  • acute kidney injury
Show 18 more
  • acute renal failure
  • pyelonephritis
  • urosepsis
  • cerebral infarction
  • stroke
  • acute cholecystitis
  • hepatitis
  • jaundice
  • myocardial infarction
  • angina
  • dyspnea
  • asthma attacks
  • chest tightness
  • breathlessness
  • cold sweat
  • pallor
  • acute myocardial infarction
  • hypertension

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
  • hypoglycemia
  • decrease in vitamin B12
  • taste disturbance
  • itching
Show 23 more
  • rash
  • angioedema
  • increased urination
  • difficulty urinating
  • abnormal liver function tests
  • hepatitis
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • increased hematocrit
  • dizziness
  • headache
  • orthostatic dizziness
  • weakness
  • chest discomfort
  • chest pain
  • fever
  • facial swelling
  • fatigue
  • rash
  • constipation
  • indigestion
  • abdominal pain

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

Storage

This medication should be stored in a tightly sealed container, protected from air and moisture, at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain its effectiveness.

Appearance and packaging

Appearance

Brownish yellow, oval film-coated tablet with a convex shape on both sides

Package unit

10 tablets/box [10 tablets/PTP x 1], 60 tablets/box [10 tablets/PTP x 6], 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

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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.