Medication info

Rinafloem Sustained Release Tablet 25/5/1000 mg (Empagliflozin, Linagliptin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›25mg / 1 tabletLinagliptin Micronized›5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
동광제약(주)
Appearance
Oval-shaped sustained-release film-coated tablets that are white and light orange, both sides convex
Packaging
Bottle packaging - 30 tablets/bottle
Approval status
Active

MFDS item code 202502782 · Approved 2025.10.28

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
This drug is taken once a day in the evening with food. For the sustained-release tablets of 10/5/1000 mg, 25/5/1000 mg, one tablet is taken once a day. For the sustained-release tablets of 5/2.5/1000 mg, 12.5/2.5/1000 mg, two tablets are taken once a day. The dosage should not exceed 25 mg of empagliflozin, 5 mg of linagliptin, and 2000 mg of sustained-release metformin hydrochloride.

Ingredients

Manufacturer
동광제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This drug helps improve blood sugar control in patients with type 2 diabetes. The three ingredients—empagliflozin, linagliptin, and metformin—work together to enhance the effectiveness of diet and exercise therapy. This allows for more effective management of blood sugar levels. When used alongside consistent use and lifestyle improvements, it greatly aids in blood sugar control. This drug is used to enhance blood sugar control in patients with type 2 diabetes.

How to take

Adult dose

This drug is taken once a day in the evening with food. For the sustained-release tablets of 10/5/1000 mg, 25/5/1000 mg, one tablet is taken once a day. For the sustained-release tablets of 5/2.5/1000 mg, 12.5/2.5/1000 mg, two tablets are taken once a day. The dosage should not exceed 25 mg of empagliflozin, 5 mg of linagliptin, and 2000 mg of sustained-release metformin hydrochloride.

Precautions

This drug can rarely cause serious lactic acidosis, so if symptoms such as fatigue, muscle pain, breathing difficulty, or abdominal pain appear, immediate medical attention should be sought. This drug should not be used in patients with allergies to the main or constituent components, patients with type 1 diabetes, patients with severely impaired kidney function, patients on dialysis, or patients with acute or chronic metabolic acidosis. Kidney function should be regularly checked to ensure it is normal, and if kidney function deteriorates, the use of this drug should be discontinued. In situations such as acute infections, dehydration, heart failure, myocardial infarction, or before and after surgery, the administration of this drug should be temporarily halted, and it can be resumed once the condition is stable. This drug can cause hypoglycemia, so blood sugar levels should be carefully monitored, especially when taken with insulin or sulfonylurea medications, and the dosage of the hypoglycemic agent may need adjustment if necessary. During the use of this drug, urinary tract infections or genital infections may occur, so treatment should be sought immediately if symptoms of infection appear. Patients at risk of fluid loss or dehydration, the elderly, and patients with cardiovascular diseases should periodically check blood pressure and fluid status when taking this drug. This drug is not recommended for patients with impaired liver function or those who consume excessive alcohol. This drug should be taken as a tablet and swallowed whole without crushing or chewing, and it is normal for the tablet coating to be excreted in feces. Patients who are pregnant or have problems with placental function, and pregnant women at risk of pre-eclampsia should not take this drug. Caution should be exercised during driving or operating machinery due to the risk of accidents caused by hypoglycemia while taking this drug. This drug may interact with other medications, so patients should be sure to inform healthcare providers about any other medications they are taking.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme general lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Urinary tract infection
  • vulvovaginal candidiasis
  • vulvitis
  • balanitis
  • and other genital infections
  • hypoglycemia
  • thirst
  • cough
  • constipation
  • oral ulcers
Show 23 more
  • itching
  • rash
  • hypoglycemia
  • increased urination
  • difficulty urinating
  • increased amylase
  • increased lipase
  • increased hematocrit
  • increased serum lipids
  • dizziness
  • anxiety
  • insomnia
  • depression
  • headache
  • fatigue
  • chest discomfort
  • weakness
  • high blood pressure
  • dry mouth
  • musculoskeletal pain
  • hair loss
  • dermatitis
  • malaise

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

Storage

This drug must be stored in a tightly sealed container to prevent exposure to air or moisture, and the storage temperature must be maintained at room temperature between 1 and 30 degrees Celsius. Storing it this way can help preserve the drug's effectiveness for a long time.

Appearance and packaging

Appearance

Oval-shaped sustained-release film-coated tablets that are white and light orange, both sides convex

Package unit

Bottle packaging - 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.