Rinac Duo Tablet 2.5/1000 mg

Adult dose

The dosage of this medication is determined based on the maximum recommended doses for each ingredient, which is linagliptin 2.5 mg and metformin 1000 mg, not exceeding twice daily. This medication is administered two times a day with meals. 1. If currently not treated with metformin: Take this medication 2.5/500 mg, 1 tablet twice a day. 2. For patients unable to sufficiently control blood sugar levels with metformin alone: For initial dosing, linagliptin 2.5 mg should be given twice a day (total daily dose of 5 mg) along with the existing dose of metformin (e.g., for patients taking metformin 1000 mg twice daily, this medication should be taken twice daily with meals at a dose of linagliptin 2.5 mg/metformin 1000 mg). 3. For patients switching from a combination therapy of linagliptin and metformin: Start with the existing doses of linagliptin and metformin when switching to this medication. 4. For patients inadequately controlled with the combination of metformin and sulfonylureas: The initial dose of this medication should consider doses similar to that of linagliptin 2.5 mg twice daily (total daily dose of 5 mg) and the existing metformin dose. When using this medication with sulfonylureas, a reduction of the sulfonylurea dose may be necessary to reduce the risk of hypoglycemia (See cautions, reference for patients who should be treated carefully). 5. For patients inadequately controlled with the combination of insulin and metformin: The initial dosing of this medication should consider doses similar to that of linagliptin 2.5 mg twice daily (total daily dose of 5 mg) and the existing metformin dose. When using this medication with insulin, a reduction of the insulin dose may be necessary to reduce the risk of hypoglycemia (See cautions, reference for patients who should be treated carefully). There have been no studies evaluating the safety and efficacy of this medication in patients switching from other oral hypoglycemic agents. Any changes in treatment for type 2 diabetes can lead to fluctuations in blood sugar control, thus careful monitoring is essential. For patients with renal impairment: This medication can be utilized with dose adjustments in patients with moderate renal impairment stage 3a (creatinine clearance [CrCl] 45 ≤ ~ < 60 ml/min or estimated glomerular filtration rate (eGFR) 45 ≤ ~ < 60 mL/min/1.73 m2) only if other symptoms that may increase the risk of lactic acidosis are not present. The starting dose of metformin should be 500 mg or 850 mg once daily, thus initiating treatment with this medication should not be done. The maximum recommended dose of metformin is 500 mg twice daily. Kidney function must be monitored closely every 3-6 months. If CrCl drops below 45 ml/min or eGFR below 45 ml/min/1.73m2, this medication must be immediately discontinued. For patients with liver impairment: This medication should not be administered to patients with hepatic dysfunction due to metformin. (See cautions, reference for patients who should not be treated).

This medication contains metformin and linagliptin, which may pose a risk of serious side effects such as lactic acidosis. Lactic acidosis is rare but can be very dangerous, particularly in patients with decreased kidney function or those with heart or liver issues, and should be avoided in these cases. This medication should not be used in patients with allergies to its ingredients or in patients with type 1 diabetes, diabetic ketoacidosis, or diabetic pre-coma. It is contraindicated in patients with severe impairment of kidney function or acute infections, dehydration, severe trauma, shock, acute myocardial infarction, etc., which may affect kidney function. It is advisable to avoid this medication in pregnant or potentially pregnant women, as well as during breastfeeding. This medication may cause hypoglycemia; therefore, caution is needed when used together with insulin or sulfonylureas, and dose adjustments may be required. To reduce the risk of lactic acidosis, kidney function should be regularly monitored, and the medication should be ceased immediately in cases of dehydration, severe vomiting, or diarrhea. If iodine-based contrast media is administered during radiological examinations, the use of this medication should be temporarily suspended before and after the examination due to the risk of kidney failure. It is also recommended to cease the use of this medication for a certain period before and after surgery and to resume only after kidney function has recovered. This medication may decrease vitamin B12 levels, so testing for vitamin B12 deficiency is advisable for long-term users. Elderly patients often experience decreased kidney function, making appropriate dose adjustments and regular kidney function tests important. During the use of this medication, if severe joint pain or blistering skin conditions occur, medical consultation should be sought immediately. This medication is not recommended for children and adolescents, as safety and efficacy have not been established. In case of overdose, gastrointestinal disturbances or lactic acidosis could occur, requiring immediate medical attention.

Serious side effects

Urticaria, angioedema, lactic acidosis, pancreatitis, bullous pemphigoid, severe swelling (edema), respiratory distress, liver dysfunction (hepatitis, liver function test abnormalities), acute pancreatitis, severe allergic reactions, acute kidney injury, acute cholangitis, acute cholecystitis, cholangitis, lightning headache, confusion of consciousness, vision impairment, paralysis, seizures, sudden and severe headache, severe edema accompanied by elevated blood pressure, increased serum creatinine

Mild side effects

• Nasopharyngitis
• hypersensitivity
• angioedema
• hypoglycemia
• taste disturbance
• cough
• loss of appetite
• diarrhea
• constipation
• nausea

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is advisable to maintain storage temperatures between 1 and 30 degrees Celsius to preserve its efficacy over time.

Appearance

Bright pink oval film-coated tablet

Package unit

60 tablets/box [10 tablets/PTPX6]