Medication info
DapaRoel Tablet 10/5mg (Dapagliflozin Propanediol Hydrate, Linagliptin)

DapaRoel Tablet 10/5mg (Dapagliflozin Propanediol Hydrate, Linagliptin)

Prescription medicationTablet
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletLinagliptin Micronized›5mg / 1 tablet
Manufacturer / importer
한림제약(주)
Appearance
Yellow round film-coated tablet
Packaging
28 tablets/box [7 tablets/PTP × 4], 30 tablets/bottle
Approval status
Active

MFDS item code 202400923 · Approved 2024.04.22

Summary

Main use
Improvement in blood sugar control for type 2 diabetes
Who uses it
Adults
Adult dosage
For patients receiving 10 mg of dapagliflozin and 5 mg of linagliptin, administer 1 tablet once daily regardless of meals.

Ingredients

Manufacturer
한림제약(주)

Efficacy & effects

Improvement in blood sugar control for type 2 diabetes

View approved original text

This medication is suitable for patients with type 2 diabetes and can be used effectively to improve blood sugar control when combined with dietary and exercise regimens. Dapagliflozin and Linagliptin work together to help improve blood glucose levels. Therefore, you can use this medication for smoother blood sugar management.

Dosage and Administration

Adult dosage

For patients receiving 10 mg of dapagliflozin and 5 mg of linagliptin, administer 1 tablet once daily regardless of meals.

Precautions

This medication should not be administered to certain patients. For example, patients with allergies to the active ingredients or excipients of this medicine, those with type 1 diabetes, patients undergoing dialysis, and those with a history of myocardial infarction should not use this medication. Careful administration is required in patients with reduced fluid volume or renal function problems. This medication may lower blood pressure or affect renal function, so the patient's condition should be closely monitored before and during administration. Patients taking insulin or sulfonylureas that can induce hypoglycemia may have a higher risk of hypoglycemia, and dosage adjustments may be necessary. In patients with heart failure, especially severe heart failure, the use of this medication is limited, and immediate cessation and consultation with a physician are required if acute pancreatitis or blistering skin conditions are suspected. During treatment with this medicine, side effects such as genital infections, urinary tract infections, decreased fluid volume, hypotension, and diabetic ketoacidosis may occur, so symptoms should be reported immediately to healthcare professionals. Elderly patients or those with decreased renal function should use this medication with caution due to the higher risk of side effects, and it is advisable for pregnant or breastfeeding women not to use this medication. Additionally, there may be interactions when this medication is taken with other medications, so it is essential to inform healthcare professionals about any current medications being taken. In case of overdose, there is no specific antidote, so strict adherence to dosage should be maintained to avoid overdose.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, cough with fever and respiratory abnormalities, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision disturbances, paralysis, urinary retention

Mild side effects

  • Constipation
  • diarrhea
  • dizziness
  • palpitations
  • weight loss
  • vulvar pruritus
  • sweating
  • cystitis
  • urinary tract infection
  • thirst
Show 26 more
  • dry mouth
  • lumbago
  • dysuria
  • polyuria
  • nocturia
  • increased hematocrit
  • elevated serum creatinine
  • rash
  • cold sweat
  • itching
  • chest pain
  • weakness
  • fatigue
  • headache
  • sensory impairment
  • nosebleed
  • insomnia
  • anxiety
  • dizziness
  • hair loss
  • arthralgia
  • musculoskeletal pain
  • limb pain
  • muscle weakness
  • myalgia
  • osteoarthritis

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and the storage temperature should be maintained between 1 to 30 degrees Celsius at room temperature. This will help preserve the medication's effectiveness.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

28 tablets/box [7 tablets/PTP × 4], 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

No questions yet.

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.