Hirus Tablet (Vildagliptin)

Adult dose

- When used alone or in combination with metformin, administer 50 mg once daily in the morning or divide into two doses of 50 mg each for a total of 100 mg once daily in the morning and evening. - When used in combination with metformin or thiazolidinediones, administer 100 mg divided into two doses of 50 mg each for a total of 100 mg once daily in the morning and evening. - When used in combination with sulfonylureas, administer 50 mg once daily in the morning. - If used with sulfonylureas, it is not more effective to administer 100 mg once daily than 50 mg once daily in thispatient population. - In cases where adequate blood sugar control cannot be achieved with sulfonylureas and metformin combination therapy, the recommended dosage when using this medication is 100 mg divided into two doses of 50 mg each for a total of 100 mg once daily in the morning and evening. - In cases where adequate blood sugar control cannot be achieved with insulin (either alone or in combination with metformin), the recommended dosage is 100 mg divided into two doses of 50 mg each for a total of 100 mg once daily in the morning and evening. - This medication can be taken regardless of meals, and dosages exceeding 100 mg per day are not recommended. - If using this medication with sulfonylureas, dosage reduction of sulfonylureas may be necessary to reduce the risk of hypoglycemia. - If a dose is missed, take the medication as soon as remembered, and resume usual dosing schedule. If it is close to the next dose time, do not take the missed dose, and do not double the dose to make up for a missed one. Patients with liver impairment This medication is not recommended for patients with liver impairment whose ALT or AST levels exceed 2.5 times the upper normal limit before administration. Patients with kidney impairment - For mild kidney impairment (creatinine clearance ≥50mL/min): No dosage adjustment is necessary. - For moderate and severe kidney impairment or end-stage renal disease (ESRD): The recommended dosage is 50 mg once daily. (Refer to "Precautions in Use" section "3. General Precautions" item 2.)

This medication should not be used by patients who are allergic to the active ingredient or any other components. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Since this medication contains lactose, it should not be used in patients with lactose intolerance or genetic lactose-related diseases. During treatment with this medication, liver dysfunction may rarely occur; therefore, regular liver function tests should be conducted before and during use. If liver enzyme levels rise more than three times the normal level or if symptoms of jaundice appear, discontinue use of this medication. Use is not recommended in patients with severe heart failure, as it may worsen heart failure symptoms, and caution is advised. This medication carries a risk of acute pancreatitis; therefore, if symptoms of pancreatitis occur, discontinue use immediately and consult a healthcare professional. When used in combination with sulfonylureas or other medications that may cause hypoglycemia, the risk of hypoglycemia may increase, and dosage adjustments may be needed. If symptoms such as dizziness occur while taking this medication, avoid driving or operating machinery. If severe joint pain or skin abnormalities such as blisters or ulcers occur, notify a healthcare professional immediately and discontinue this medication. It is safe not to use this medication in pregnant or breastfeeding women, and it is not recommended for children and adolescents under 18 years of age. There is no specific antidote for overdose; therefore, symptomatic supportive treatment should be initiated, and this medication cannot be removed by hemodialysis. Keep out of reach of children and avoid transferring to other containers.

Serious side effects

• Hives
• angioedema
• severe swelling (peripheral edema)
• chest tightness
• difficulty breathing
• hepatic dysfunction including hepatitis
• jaundice
• acute pancreatitis
• skin rashes and blisters
• bullous pemphigoid

Mild side effects

• Headache
• dizziness
• fatigue
• nausea
• constipation
• weakness
• weight gain
• hypoglycemia
• gastroesophageal reflux
• diarrhea

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is important to store it in a cool place below 30 degrees Celsius to maintain its effectiveness.

Appearance

Round tablet that is white to pale yellow in color

Package unit

30 tablets/box [10 tablets/PTP X 3]