NovoNorm Special Precautions

General: Repaglinide should be prescribed if poor blood glucose control and symptoms of diabetes persist despite diet, exercise and weight reduction.
When a patient stabilised on any oral hypoglycaemic agent is exposed to stress such as fever, trauma, infection or surgery, a loss of glycaemic control may occur. In such cases, it may be necessary to discontinue repaglinide and treat with insulin on a temporary basis.
Hypoglycaemia: Repaglinide, like other insulin secretagogues, is capable of producing hypoglycaemia.
Combination with insulin secretagogues: The blood glucose-lowering effect of OADs decreases in many patients over time. This may be due to progression of the severity of the diabetes or to diminished responsiveness to the product. This phenomenon is known as secondary failure, to distinguish it from primary failure, where the product is ineffective in an individual patient when first given. Adjustment of dose and adherence to diet and exercise should be assessed before classifying a patient as a secondary failure.
Repaglinide acts through a distinct binding site with a short action on the β-cells. Use of repaglinide in case of secondary failure to insulin secretagogues has not been investigated in clinical trials.
Trials investigating the combination with other insulin secretagogues have not been performed.
Combination with Neutral Protamine Hagedorn (NPH) insulin or thiazolidinediones: Trials of combination therapy with NPH insulin or thiazolidinediones have been performed. However, the benefit risk profile remains to be established when comparing to other combination therapies.
Combination with metformin: Combination treatment with metformin is associated with an increased risk of hypoglycaemia.
Concomitant use: Repaglinide should be used with caution or be avoided in patients receiving medicinal products which influence repaglinide metabolism (see Interactions). If concomitant use is necessary, careful monitoring of blood glucose and close clinical monitoring should be performed.
Acute coronary syndrome: The use of repaglinide might be associated with an increased incidence of acute coronary syndrome (e.g. myocardial infarction).
Effects on ability to drive and use machines: NovoNorm has no direct influence on the ability to drive and use machines but may cause hypoglycaemia. Patients should be advised to take precautions to avoid hypoglycaemia while driving. This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.