Gavus Tablet 50mg (Vildagliptin)

Adult dose

This medicine is administered as monotherapy, or, in patients with no prior experience of antidiabetic drug treatment, in combination with metformin at 50mg once daily in the morning or 100mg per day in two divided doses of 50mg each in the morning and evening. When adequate glycemic control cannot be achieved with metformin or a thiazolidinedione alone, the recommended dose of this medicine in combination with metformin or a thiazolidinedione is 100mg per day, in two divided doses of 50mg each in the morning and evening. When adequate glycemic control cannot be achieved with a sulfonylurea alone, the recommended dose of this medicine in combination with a sulfonylurea is 50mg once daily in the morning. In this patient group, vildagliptin 100mg once daily was not more effective than 50mg once daily. When adequate glycemic control cannot be achieved with combination therapy of a sulfonylurea and metformin, the recommended dose of this medicine as add-on therapy (third-agent therapy) is 100mg per day, in two divided doses of 50mg each in the morning and evening. When adequate glycemic control cannot be achieved with insulin therapy (insulin alone or in combination with metformin), the recommended dose of this medicine as add-on therapy is 100mg per day, in two divided doses of 50mg each in the morning and evening. This medicine may be taken with or without food, and doses greater than 100mg per day are not recommended. When this medicine is used in combination with a sulfonylurea, a reduction in the sulfonylurea dose may be necessary to reduce the risk of hypoglycemia. If you forget to take this medicine, take it as soon as you remember and take the next dose at your usual time. If you remember close to the time of your next dose, skip the missed dose. Do not take a double dose at one time to make up for a missed dose. Patients with hepatic impairment This medicine is not recommended for patients with hepatic impairment whose ALT or AST level exceeds 2.5 times the upper limit of normal before treatment. Patients with renal impairment Mild renal impairment (creatinine clearance ≥50mL/min): No dose adjustment is necessary. Moderate or severe renal impairment or end-stage renal disease (ESRD): A dose of 50mg once daily is recommended. (Refer to Section 2) under ‘3. General precautions’ in the Precautions for Use.)

This medication should not be used in certain patients. For example, patients allergic to any component of this medication, as well as those with type 1 diabetes or diabetic ketoacidosis, should not take this drug. Additionally, since it contains lactose, it should not be taken by patients with genetic conditions such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. Liver function should be periodically monitored during treatment, as liver function abnormalities can occur rarely. If symptoms of hepatitis or abnormally high liver function test results develop, consulting a physician immediately and stopping the medication is necessary. In patients with severe heart failure, the use of this medication is not recommended, and if any unusual skin symptoms like blisters or ulcers occur, medical personnel should be notified immediately. Due to the risk of acute pancreatitis, if symptoms such as abdominal pain or vomiting appear, the medication should be discontinued immediately and the patient should see a doctor. There may be an increased risk of hypoglycemia when taking this medication with other hypoglycemic agents, so caution should be exercised for hypoglycemic symptoms when combined with other medications, and dosage adjustments should be made if necessary. Symptoms such as dizziness may occur, so caution is necessary when driving or operating machinery. Pregnant and breastfeeding women should not take this medication, nor is it recommended for children under 18 years of age, as safety and efficacy have not been established. In the case of overdose, there are no specific antidotes, so appropriate treatment should be received based on symptoms, and this medication is not removed by hemodialysis. Finally, keep this medication out of the reach of children, and do not store it in a different container.

• Hepatitis
• liver function abnormalities
• elevated transaminase levels
• angioedema
• tremors
• headache
• dizziness
• fatigue
• nausea
• hypoglycemia

This medication should be stored in a tightly closed container that prevents air from entering, in a cool place below 30 degrees Celsius, taking care to prevent moisture exposure. This is to maintain the efficacy of the medication and prevent deterioration.

Appearance

White to light yellow round tablets

Package unit

28 tablets (14 tablets/PTP packaging × 2)