Information about Noveldo Met
Each Noveldo-met tablet contains:
Either: 50 mg vildagliptin and 500 mg metformin hydrochloride,
Or: 50 mg vildagliptin and 850 mg metformin hydrochloride,
Or: 50 mg vildagliptin and 1,000 mg metformin hydrochloride.
NOVELDO-MET is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes whose diabetes is not adequately controlled on metformin hydrochloride alone or who are already treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets.
NOVELDO-MET is contraindicated in patients:
-With known hypersensitivity to vildagliptin or metformin hydrochloride or to any of the excipients.
-With renal disease or renal dysfunction (e.g., serum creatinine levels ≥1.5 mg/dL in males and ≥ 1.4 mg/dL in females or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicaemia.
- With congestive heart failure requiring pharmacologic treatment.
- With acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
- NOVELDO-MET should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.
The majority of side effects was mild in severity and resolved with ongoing vildagliptin treatment.
A decrease of vitamin B12 absorption with decrease of serum levels has been very ra0rely observed in patients treated long-term with metformin and appears generally to be 0without clinical significance. Consideration of such aetiology is recommended if a patient presents with megaloblastic anaemia.
Do00sage and Administration:
-The use of antihyperglycaemic therapy in the management of T2D should be individualized on the basis of effectiveness and tolerability.
-NOVELDO-MET should be given with meals to reduce the gastrointestinal side effects associated with metformin hydrochloride. When using NOVELDO-MET the maximum daily dose of vildagliptin (100 mg) should not be exceeded.
-Starting dose for patients inadequately controlled on metformin hydrochloride monotherapy: NOVELDO-MET may be initiated at either the 50 mg/500 mg, 50 mg/850 mg or 50 mg/1,000 mg tablet strength twice daily.
-Starting dose for patients switching from combination therapy of vildagliptin plus metformin hydrochloride as separate tablets:
NOVELDO-MET may be initiated with either the 50 mg/500 mg, 50 mg/850 mg or 50 mg/1,000 mg tablet strength based on the dose of vildagliptin or metformin already being taken.
Film coated tablets in strength of: either 50mg/500mg, or 50mg/ 850mg or 50mg/1000mg in Packs of 20 tablets.