Tradjult MPA Sustained Release Tablet 10/5/1000 mg (Empagliflozin, Linagliptin, Metformin)

Adult dose

The dosage of this medication should be determined based on the current therapy, efficacy, and tolerability of each patient, limited to the maximum daily doses of empagliflozin 25 mg, linagliptin 5 mg, and sustained-release metformin hydrochloride 2000 mg. This medication should be taken once daily in the evening with meals to reduce gastrointestinal adverse reactions associated with metformin hydrochloride, and dosage adjustments should be done gradually if needed.

This medication may cause a rare complication known as lactic acidosis, which can lead to death in severe cases, so caution is required. This medication should not be used by individuals who are allergic to the active or inactive ingredients, patients with type 1 diabetes, patients with acute or chronic metabolic acidosis, patients undergoing dialysis, individuals with severe renal impairment, or patients with heart failure. The use of this medication should be discontinued before and after tests using iodinated contrast agents, and it may be resumed only after renal function has been confirmed to be normal. If the patient undergoes major surgery or experiences a severe infection, the use of this medication should also be temporarily halted, and it should be restarted only after the patient resumes normal food intake and renal function is restored. Since this medication may be affected by renal function, regular monitoring of renal function is essential before and during treatment. Patients with heart failure or a history of pancreatitis should take special care when using this medication and should discontinue it immediately and consult a physician if symptoms of pancreatitis appear. This medication may cause hypoglycemia; therefore, when taken with insulin or sulfonylureas, patients should be alert for symptoms of hypoglycemia and dosage adjustments may be necessary. There is an increased risk of urinary tract infections and genital fungal infections; therefore, prompt treatment should be sought if symptoms of infection occur. During treatment, dehydration, hypotension, and fluid loss may occur, so particularly in the elderly or individuals with cardiovascular disease, careful monitoring of blood pressure and fluid status is essential. This medication should not be administered to patients with impaired liver function, and consultation with a physician should occur immediately if symptoms of liver dysfunction appear. There is a risk of vitamin B12 deficiency; hence, patients on long-term therapy should regularly check their vitamin B12 levels. Alcohol consumption should be avoided while taking this medication, as excessive alcohol intake can increase the risk of lactic acidosis. Caution is required when driving or operating machinery due to the possibility of hypoglycemia, particularly when taken with insulin or sulfonylureas. Tablets should be swallowed whole without chewing or crushing, and it is normal for the tablet coating to be excreted in the stool. This medication may interact with other drugs; therefore, any other medications being taken must be disclosed to a doctor or pharmacist.

Serious side effects

Hives, severe swelling (edema), ketoacidosis, pancreatitis, angioedema, thrombosis of vascular stenting, severe edema associated with increased blood pressure, increased serum creatinine, decreased glomerular filtration rate, lactic acidosis, perineal necrosis, severe allergic reactions, serious skin adverse reactions, liver abnormalities (jaundice), severe neurological symptoms, significant edema or urination difficulty, difficulty breathing, asthma attacks, respiratory changes accompanied by cough and fever, acute kidney injury.

Mild side effects

• Urinary tract infections
• vulvovaginitis
• balanitis and other genital infections
• pharyngitis
• cough
• constipation
• oral ulcers
• itching
• rash
• hypoglycemia

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is room temperature between 1°C and 30°C.

Appearance

Yellow oval film-coated sustained release tablet

Package unit

30 tablets/bottle