Medication info
M-Shoobet 25 mg (Empagliflozin 2L-Proline)

M-Shoobet 25 mg (Empagliflozin 2L-Proline)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin 2L-Proline›37.766mg / 1 tablet
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
Light yellow, biconvex, oval film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202502438 · Approved 2025.09.15

Summary

Main use
Blood sugar control and prevention of cardiovascular events
Who takes it
Adults
Adult dose
Administer 10 mg once daily for monotherapy and in combination therapy with other blood sugar-lowering agents such as insulin. If well tolerated and further blood sugar control is required, the dosage can be increased to 25 mg once daily. It can be taken regardless of meals, and the tablets should be swallowed whole. If a dose is missed, take it as soon as remembered, and do not take two doses on the same day.

Ingredients

Manufacturer
주식회사제뉴원사이언스

Efficacy & effects

Blood sugar control and prevention of cardiovascular events

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

This medication is used to improve blood sugar control in adults with type 2 diabetes. It is administered as an adjunct to diet and exercise and can be used as monotherapy or in combination with other medications. It is particularly effective in patients whose blood sugar is not adequately controlled. Additionally, it is recommended for safe use based on clinical trial information regarding the occurrence of cardiovascular events in patients with type 2 diabetes accompanied by cardiovascular disease. This medication helps improve patients' health by aiding diabetes management through blood sugar control.

How to take

Adult dose

Administer 10 mg once daily for monotherapy and in combination therapy with other blood sugar-lowering agents such as insulin. If well tolerated and further blood sugar control is required, the dosage can be increased to 25 mg once daily. It can be taken regardless of meals, and the tablets should be swallowed whole. If a dose is missed, take it as soon as remembered, and do not take two doses on the same day.

Precautions

This medication should not be administered to specific patients. First, patients who are allergic to the main ingredient or components of this medication should not take it. Patients with type 1 diabetes or diabetic ketoacidosis may also be at risk if they use this medication. Furthermore, patients with lactose intolerance or genetic galactose metabolism disorders should not take this medication due to the lactose it contains. Patients with impaired kidney function should use this medication cautiously. In particular, in patients with significantly reduced kidney function, the effectiveness of this medication may diminish, or the risk of side effects may increase; thus, regular kidney function testing is required. Patients with chronic heart failure or chronic kidney disease should also consult their doctor sufficiently before using this medication. The risk of hypoglycemia may increase when this medication is used in conjunction with blood sugar-lowering medications such as insulin or sulfonylureas; therefore, dosage adjustments may be necessary when combined with such medications. Major side effects that may occur while taking this medication include hypoglycemia, genital infections, urinary tract infections, increased urination, decreased fluid volume, liver function abnormalities, etc. Hypoglycemia, in particular, may occur more frequently when taken with insulin or sulfonylureas, so caution is advised. Serious metabolic disorders such as ketoacidosis may rarely occur in association with this medication; thus, if symptoms such as nausea, vomiting, abdominal pain, or difficulty in breathing appear, it is essential to inform medical personnel immediately. Additionally, elderly patients or those with cardiovascular disease who are at risk of fluid loss or low blood pressure should closely monitor their fluid status while taking this medication. This medication may impact liver function; therefore, patients with liver disease should consult their doctor before taking it. Caution is necessary while driving or operating machinery, as this medication may increase the risk of hypoglycemia. Pregnant women or nursing mothers are advised to avoid taking this medication, and it should be discontinued immediately if pregnancy is confirmed. Additionally, the safety and efficacy of this medication have not been established in children under 18 years of age. There have been no reported special toxicities in the case of overdose, however, if overdose occurs, immediate medical attention should be sought for appropriate treatment. This medication must be stored out of reach of children, and it is crucial to avoid transferring it to other containers to maintain safety and quality.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, ketoacidosis, urinary sepsis, pyelonephritis, perineal necrosis, severe allergic reaction symptoms, severe skin aberration symptoms, difficulty breathing, jaundice, liver dysfunction symptoms, sudden and severe headache, seizures, confusion, visual disturbances, paralysis, severe swelling or urination abnormalities, deep vein thrombosis, acute kidney injury, angina, unstable angina, acute cholecystitis, autoimmune hepatitis

Mild side effects

  • Hypoglycemia
  • constipation
  • skin itching
  • rash
  • increased urination
  • difficulty urinating
  • interstitial nephritis
  • thirst
  • increased serum lipid levels
  • increased serum creatinine
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  • decreased glomerular filtration rate
  • increased hematocrit
  • vulvar pruritus
  • balanitis
  • fluid volume loss
  • headache
  • dizziness
  • drowsiness
  • fatigue
  • peripheral edema
  • facial edema
  • fever
  • facial swelling
  • edema
  • blood and lymphatic system disorders
  • weight changes
  • indigestion
  • vomiting

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius. This way, the effectiveness and safety of the medication can be preserved for a longer period.

Appearance and packaging

Appearance

Light yellow, biconvex, oval 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.