Medication info

Empagliflozin and Linagliptin Tablets 10/5 mg

Prescription medicationTablet경구
Ingredient · strength
Linagliptin Micronized›5mg / 1 tabletEmpagliflozin Amorphous›10mg / 1 tablet
Manufacturer / importer
대웅바이오(주)
Appearance
Yellow film-coated tablets that are round and convex on both sides
Packaging
Bottle) 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202502451 · Approved 2025.09.16

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
The recommended starting dose of this medication is once daily 10 mg empagliflozin / 5 mg linagliptin. If additional blood sugar control is needed and the patient tolerates it, the dose may be increased to 25/5 mg once daily. Administer at the usual dosage and can be taken regardless of meals. The tablets should be swallowed whole. If a dose is missed, take it as soon as remembered, but if the next dose is within 12 hours, skip the missed dose and continue as scheduled.

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is used in conjunction with diet and exercise to assist in blood sugar control for patients with type 2 diabetes. The components empagliflozin and linagliptin act together to effectively improve blood sugar levels. Therefore, this medication is used for blood sugar control in patients with type 2 diabetes.

How to take

Adult dose

The recommended starting dose of this medication is once daily 10 mg empagliflozin / 5 mg linagliptin. If additional blood sugar control is needed and the patient tolerates it, the dose may be increased to 25/5 mg once daily. Administer at the usual dosage and can be taken regardless of meals. The tablets should be swallowed whole. If a dose is missed, take it as soon as remembered, but if the next dose is within 12 hours, skip the missed dose and continue as scheduled.

Precautions

This medication contains two components, empagliflozin and linagliptin, and is primarily used for the treatment of type 2 diabetes. First, this medication should not be used by individuals allergic to empagliflozin or linagliptin, or any other components of this medication, by patients with type 1 diabetes, diabetic ketoacidosis, or patients undergoing kidney dialysis. Since this medication may affect kidney function, it is important to have regular kidney function tests before and during treatment. Care should be taken in patients with decreased kidney function. For patients with mild to moderate heart failure, caution is advised; it is not recommended for patients with severe heart failure. The linagliptin component may rarely cause acute pancreatitis; if severe abdominal pain persists, discontinue use immediately and consult your doctor. Additionally, linagliptin may rarely trigger bullous pemphigoid; if any skin abnormalities occur, inform healthcare personnel immediately. The most commonly reported side effect while taking this medication is urinary tract infection, which may occur more frequently in females. Genital infections may also occur, so inform a healthcare professional if symptoms arise. Hypoglycemia has also been reported, especially when used in conjunction with insulin or sulfonylurea medications, so caution is advised regarding hypoglycemia risks. Patients with low blood pressure or inadequate fluid volume, as well as elderly patients over 75 years of age, are at risk of dehydration or hypotension, and their condition should be closely monitored while using this medication. This medication may rarely cause a serious metabolic disorder called ketoacidosis in patients with diabetes, so immediate treatment is necessary if symptoms like vomiting, abdominal pain, or difficulty breathing occur. Furthermore, this medication may affect lithium concentrations in the blood; if undergoing lithium treatment, frequent monitoring of blood levels is necessary. It is generally recommended not to use this medication during pregnancy unless absolutely necessary, and it is advised to discontinue breastfeeding if nursing. Safety and efficacy have not been confirmed in children under 18, and it is best not to use this medication in this age group. Finally, while taking this medication, caution is advised when driving or operating machinery due to the risk of accidents from hypoglycemia. If any unusual symptoms develop during treatment, consult healthcare personnel immediately.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • ketoacidosis
  • pancreatitis
  • bullous pemphigoid
  • pyelonephritis
  • urosepsis
  • pneumonia
  • cerebral infarction
  • acute myocardial infarction
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  • congestive heart failure
  • cardiac arrest
  • thrombus in vascular stents
  • acute kidney injury
  • end-stage renal disease
  • acute cholecystitis
  • acute cholangitis
  • cholangitis
  • hepatitis
  • liver transplant failure
  • perineal necrosis
  • severe swelling
  • severe rash with high fever
  • blisters
  • skin peeling
  • oral/ocular mucosal pain
  • chest tightness.

Mild side effects

  • Urinary tract infection
  • vulvovaginitis
  • vulvitis
  • balanitis
  • and other genital infections
  • nasopharyngitis
  • cough
  • constipation
  • oral ulcer formation
  • itching
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  • rash
  • depletion of blood volume
  • increased urination
  • urination difficulties
  • increased serum lipids
  • increased amylase
  • increased lipase
  • increased hematocrit
  • increased serum creatinine
  • decreased hemoglobin
  • weight gain
  • weight loss
  • insomnia
  • depression
  • dizziness
  • headache
  • chest discomfort
  • itching.

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

Storage

This medication should be stored in a sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the medication's effectiveness and safety.

Appearance and packaging

Appearance

Yellow film-coated tablets that are round and convex on both sides

Package unit

Bottle) 30 tablets/bottle, 100 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.