Sitagliptin and Metformin Hydrochloride Tablets 50/850 mg

Adult dose

This medicine is generally taken twice daily with food, and the dosage is gradually increased to reduce gastrointestinal adverse reactions caused by metformin. 1. Patients not currently being treated with metformin: - Start with an initial dose of 50/500 mg taken twice daily, one tablet at a time, and can be increased to 50/1000 mg taken twice daily, one tablet at a time. 2. Patients receiving treatment with metformin:

This medicine contains two components: sitagliptin and metformin. Firstly, sitagliptin is a medication that helps in blood sugar control and may cause hypersensitivity reactions, so if allergic symptoms arise, administration should be stopped immediately. In particular, serious allergic reactions such as anaphylaxis, angioedema, and severe skin disorders can occur within 3 months of administration, so caution is necessary. Furthermore, sitagliptin poses a risk of acute pancreatitis, inflammation of the pancreas, and if symptoms such as abdominal pain, vomiting, and loss of appetite occur during treatment, one should consult a doctor immediately. Metformin helps lower blood sugar but may rare instances cause a severe side effect called lactic acidosis. Lactic acidosis manifests as muscle pain, difficulty breathing, fatigue, and abdominal pain, and should these symptoms arise, one must discontinue the medication and seek medical attention immediately. This medicine should not be administered to patients with moderate or severe impaired renal function, severe infections, acute myocardial infarction, heart failure, or to women who are pregnant or breastfeeding. Moreover, before and after examinations using iodinated contrast agents, medication should be suspended for a certain period to prevent worsening kidney function, and kidney function should be checked before resuming treatment. During treatment, the risk of hypoglycemia exists, so one must not skip or have irregular meals, and care should be taken when engaging in vigorous exercise. This medicine may cause gastrointestinal disturbances (diarrhea, nausea, vomiting, abdominal pain), headaches, and upper respiratory tract infections. Particularly, caution is required as the risk of hypoglycemia may increase when used with other hypoglycemic agents like insulin or sulfonylurea. Regular monitoring of kidney function and blood tests should be conducted before and during treatment, and since vitamin B12 deficiency may occur, supplementation may be necessary. Alcohol may increase the risk of side effects from this medicine, so it is important to avoid excessive drinking while taking it. If surgery is forthcoming, or if there is a severe infection or state of dehydration, medication should be temporarily suspended, and should be restarted after recovery as directed by a physician. Finally, it is crucial to see healthcare personnel immediately if any unusual symptoms occur during treatment with this medicine.

Serious side effects

Hives, angioedema, anaphylaxis, rash, cutaneous vasculitis, Stevens-Johnson syndrome, severe edema, acute pancreatitis (including hemorrhagic or necrotizing), acute renal failure, difficulty breathing, unstable angina, severe allergic reactions, severe and disability-associated arthralgia, bullous pemphigoid, hypoglycemia, acute pancreatitis, acute renal failure, difficulty breathing, acute myocardial infarction, lactic acidosis, liver abnormalities (jaundice), acute renal failure, severe

Mild side effects

• Diarrhea
• upper respiratory tract infections
• headaches
• nausea
• vomiting
• abdominal pain
• nasopharyngitis
• constipation
• muscle pain
• limb pain

This medicine should be stored in a tightly sealed container to prevent air ingress, and it is best kept at room temperature between 1 and 30 degrees Celsius. Therefore, it is important not to place it in excessively hot or cold locations.

Appearance

Pink oval film-coated tablets

Package unit

30 tablets/box[(10 tablets/PTP×3)]