Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

General

Repaglinide should only be prescribed if poor blood glucose control and symptoms of diabetes persist despite adequate attempts at dieting, exercise and weight reduction.

When a patient stabilised on any oral hypoglycaemic medicinal product is exposed to stress such as fever, trauma, infection or surgery, a loss of glycaemic control may occur. At such times, 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 oral hypoglycaemic medicinal products decreases in many patients over time. This may be due to progression of the severity of the diabetes or to diminished responsiveness to the medicinal product. This phenomenon is known as secondary failure, to distinguish it from primary failure, where the medicinal 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.
Acute coronary syndrome

The use of repaglinide might be associated with an increased incidence of acute coronary syndrome (e.g. myocardial infarction), see sections 4.8 and 5.1.

Concomitant use

Repaglinide should be used with caution or be avoided in patients receiving medicinal products which influence repaglinide metabolism (see section 4.5). If concomitant use is necessary, careful monitoring of blood glucose and close clinical monitoring should be performed.

Effects on Driving

4.7    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 whilst 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.