Trudapael Tablet 10/5 mg (Dapagliflozin, Linagliptin)

Adult dosage

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

This medication should not be administered to patients who have had allergic reactions to the active ingredients or excipients. Patients with Type 1 diabetes, diabetic ketoacidosis, or those undergoing dialysis should also avoid using this medication. Patients with a history of myocardial infarction or heart disease should use this medication with caution. Patients who are dehydrated or have impaired kidney function should assess their fluid status and kidney function before taking this medication, and monitor for symptoms of hypotension and changes in kidney function during treatment. The efficacy of blood sugar control may vary depending on kidney function; therefore, this medication is not recommended for patients with moderate to severe renal impairment. When taken in conjunction with hypoglycemic agents such as insulin or sulfonylureas, the risk of hypoglycemia may increase, so adjustments to the dosage of these medications may be necessary when combined with this medication. The use of this medication is not recommended for patients with heart failure, particularly those with severe heart failure, and should be used cautiously in patients with mild heart failure. Side effects such as acute pancreatitis and bullous skin conditions may occur, so if severe abdominal pain or skin abnormalities present during treatment, consult a physician immediately. This medication may increase the risk of genital and urinary tract infections, so prompt treatment should be received if symptoms of infection appear. Elderly patients or those on diuretics have an increased risk of reduced fluid volume and hypotension, so regular monitoring of status is necessary. During pregnancy or breastfeeding, it is advisable not to use this medication, as safety has not been established; consultation with a specialist is recommended. During the use of this medication, specific tests for blood sugar monitoring (1,5-anhydrosorbitol test) may not be accurate, and blood sugar should be monitored using alternative methods. In the event of overdose, as there is no specific antidote, seek immediate medical attention for appropriate treatment.

Serious side effects

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

Mild side effects

• Constipation
• diarrhea
• dizziness
• palpitations
• weight loss
• vulvar pruritus
• sweating
• cystitis
• urinary tract infection
• thirst

Store this medication in a sealed container to protect it from air and moisture, preferably at room temperature between 1°C and 30°C.

Appearance

Yellow round film-coated tablet

Package unit

28 tablets/box [7 tablets/PTP × 4], 30 tablets/bottle