Sitafolmin XR Extended-Release Tablet 50/500 mg

Adult dose

This medication should be taken once daily in the evening with meals to reduce gastrointestinal adverse reactions caused by metformin; the dosage should be gradually increased. To maintain its extended-release characteristics, swallow the tablets whole without splitting, crushing, chewing, or dissolving. The extended-release tablet of this medication at 100/1000 mg is to be taken once daily as 1 tablet. For the extended-release tablets of 50/500 mg or 50/1000 mg, the dosage is

This medication contains sitagliptin and metformin as active ingredients and helps in blood glucose control. Severe allergic reactions may occur while taking this medication; therefore, if symptoms such as hives, rash, difficulty breathing, or swelling of the face or neck appear, discontinue the medication immediately and consult a doctor. Serious side effects such as acute pancreatitis, which involves inflammation of the pancreas, have been reported. If symptoms such as abdominal pain, vomiting, nausea, or fever occur, inform a medical professional right away. This medication should not be administered to patients with significantly impaired kidney function, severe infections or dehydration, heart failure, acute myocardial infarction, or septic conditions. Additionally, if undergoing exams involving radiographic contrast agents, the medication should be discontinued for a certain period before and after the examination, and it should be resumed only after normal kidney function has been confirmed. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication. As this medication may cause hypoglycemia, especially when taken with insulin or sulfonylureas, blood glucose levels should be monitored carefully. Due to the metformin component, there is a rare but serious risk of lactic acidosis; if symptoms such as fatigue, muscle pain, difficulty breathing, or abdominal pain occur, visit a healthcare facility immediately. Regular monitoring of kidney function, blood tests, and vitamin B12 levels during treatment is important. Alcohol consumption can increase the risk of lactic acidosis; thus, it is advisable to avoid drinking alcohol while on this medication. If undergoing surgery, discontinue this medication 48 hours before the procedure and resume it only after the patient’s condition stabilizes and kidney function is confirmed to be normal. Safety and efficacy have not been established for children and adolescents under 18 years of age; therefore, it should not be used in these populations. Elderly patients may experience reduced kidney function, so kidney function should be monitored regularly, and dosage adjustments should be made as necessary. In case of an overdose, seek medical attention immediately, as some of the medication may be removed through blood dialysis. Regular blood glucose monitoring and consistent adherence to diet and exercise regimens are important while taking this medication.

Serious side effects

Hives, severe swelling (edema), anaphylaxis, angioedema, Stevens-Johnson syndrome, exfoliative skin disorders, fatal/non-fatal hemorrhagic or necrotizing pancreatitis, acute pancreatitis, severe hypoglycemia, acute renal failure, severe edema or urination issues, severe allergic reactions, severe skin adverse reactions, respiratory problems, liver anomalies (jaundice), serious neurological symptoms

Mild side effects

• Diarrhea
• upper respiratory tract infection
• headache
• nausea
• vomiting
• abdominal pain
• nasopharyngitis
• constipation
• muscle pain
• limb pain

This medication is sensitive to air and moisture, so it should be stored in a sealed container. Store at room temperature between 1 °C and 30 °C. This will help maintain its effectiveness.

Appearance

Pale blue, bilaterally convex, oval-shaped extended-release film-coated tablets

Package unit

30 tablets/bottle