Bilda Duo M Tablet 50/1000 Milligrams (Vildagliptin, Metformin Hydrochloride)

Adult dose

For the treatment of patients with type 2 diabetes, the dosage of this medication should be individualized based on efficacy and tolerability, not exceeding vildagliptin 100mg and metformin 2000mg. Vildagliptin doses greater than 100mg per day are not recommended. This medication is generally administered with meals or immediately after meals to reduce gastrointestinal adverse reactions caused by metformin. 1. For patients with no prior experience with diabetes medications and where monotherapy does not provide sufficient blood sugar control: The initial dosage of this medication can be 50/500mg once daily, gradually increasing to 50/1000mg twice daily, 1 tablet at a time. 2. For patients where blood sugar is inadequately controlled by metformin monotherapy: The initial dosage of this medication should be tailored to the existing doses of vildagliptin 100mg and metformin. The initial dosage can be 1 tablet of this medication 50mg/850mg or 50mg/1000mg taken twice daily, once in the morning and once in the evening. 3. For patients transitioning from a combination therapy of vildagliptin and metformin: Patients transitioning from existing dosages of vildagliptin and metformin can start this medication based on those doses. 4. When used in combination with sulfonylureas or insulin: Vildagliptin 50mg should be administered twice daily (total of 100mg per day), while metformin should be administered similarly to the previous doses. - When this medication is combined with sulfonylureas, dosage reduction of sulfonylureas may be necessary to reduce the risk of hypoglycemia. Studies reviewing the safety and efficacy of transitioning from other oral hypoglycemic agents to this medication have not been conducted. Any changes in the treatment regimen for type 2 diabetes may lead to changes in blood sugar control; hence, monitoring must be appropriately conducted. In case of missed doses, take the next dose with the next meal instead of doubling the missed dose. Patients with liver impairment, including those with ALT or AST levels exceeding 2.5 times the upper limit of normal before administration, should not use this medication.

This medication may cause severe lactic acidosis or hypoglycemia; thus, it should not be used in patients with moderate to severe renal impairment or heart failure. Patients scheduled to undergo tests using radiocontrast iodine should stop taking this medication 48 hours prior to the test and resume only after verifying that renal function is normal post-examination. Patients with allergic reactions to this medication or those with type 1 diabetes or diabetic ketoacidosis should not use it. During severe infections, major trauma, or perioperative periods, this medication should be temporarily discontinued, and resumed only after the condition stabilizes. Patients with poor nutritional status, impaired liver function, or those who consume excessive alcohol should use this medication with caution. It is safer for pregnant or breastfeeding women to avoid this medication. This medication carries a risk of hypoglycemia or lactic acidosis when meals are irregular, during vigorous exercise, or when used in conjunction with other medications, thus caution is required. Occasional side effects such as headaches, dizziness, nausea, and hypoglycemia may occur, so consultation with a doctor is advised if symptoms are severe. Elderly patients with diminished renal function should regularly monitor renal function and adjust the dosage accordingly. It is advisable to avoid alcohol consumption during this medication, and regular blood tests may be necessary as vitamin B12 levels can decrease. Dizziness may occur when driving or operating machinery, so caution is advised. In case of overdose, it is necessary to visit a medical facility immediately for appropriate treatment, and dialysis may be required in some cases. Children should not use this medication as its safety and efficacy have not been established. This medication does not replace insulin treatment for patients requiring insulin, and regular monitoring of blood sugar and glycated hemoglobin is crucial in diabetes management. If symptoms such as blisters or ulcers appear on the skin, immediate reporting to a physician is necessary. Any changes in health status during this medication should be promptly discussed with healthcare providers for appropriate actions.

Serious side effects

Hives, angioedema, blisters and exfoliative skin lesions, hepatitis, jaundice, severe lactic acidosis, dyspnea, lactic acidosis-related deaths, acute pancreatitis, severe edema, worsening renal function, abnormal liver function, acute renal failure, cardiovascular collapse, sudden and severe headache, confusion, paralysis, bullous pemphigoid, severe arthralgia associated with disability

Mild side effects

• Tremor
• headache
• dizziness
• fatigue
• nausea
• hypoglycemia
• gastroesophageal reflux
• diarrhea
• bloating
• chills

This medication is sensitive to air and moisture; thus, it must be stored in a tightly sealed container. Additionally, it should be kept in a cool place below 30 degrees Celsius to preserve its effectiveness.

Appearance

Dark yellow elliptical film-coated tablet

Package unit

Bottle - 30 tablets/bottle, Bottle - 100 tablets/bottle