Starlix

Posology Adults Nateglinide should be taken within 1 to 30 minutes before meals (usually breakfast, lunch and dinner). The dosage of nateglinide should be determined by the physician according to the patient’s requirements. The recommended starting dose is 60 mg three times daily before meals, particularly in patients who are near goal HbA1c.

This may be increased to 120 mg three times daily. Dose adjustments should be based on periodic glycosylated haemoglobin (HbA1c) measurements. Since the primary therapeutic effect of Starlix is to reduce mealtime glucose (a contributor to HbA1c), the therapeutic response to Starlix may also be monitored with 1–2 hour post-meal glucose.

The recommended maximum daily dose is 180 mg three times daily to be taken before the three main meals. Special populations Elderly The clinical experience in patients over 75 years of age is limited. Renal impairment No dose adjustment is necessary in patients with mild to moderate renal impairment.

Although there is a 49% decrease in Cmax of nateglinide in dialysis patients, the systemic availability and half-life in diabetic subjects with moderate to severe renal insufficiency (creatinine clearance 15–50 ml/min) was comparable between renal subjects requiring haemodialysis and healthy subjects.

Although safety was not compromised in this population dose adjustment may be required in view of low Cmax. Hepatic impairment No dose adjustment is necessary for patients with mild to moderate hepatic impairment. As patients with severe liver disease were not studied, nateglinide is contraindicated in this group.

Paediatric population There are no data available on the use of nateglinide in patients under 18 years of age, and therefore its use in this age group is not recommended. Medicinal Product no longer authorised 4

Based on the experience with nateglinide and with other hypoglycaemic agents, the following adverse reactions have been seen. Frequencies are defined as: very common (1/10); common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Hypoglycaemia As with other antidiabetic agents, symptoms suggestive of hypoglycaemia have been observed after administration of nateglinide. These symptoms included sweating, trembling, dizziness, increased appetite, palpitations, nausea, fatigue, and weakness.

These were generally mild in nature and easily handled by intake of carbohydrates when necessary. 1% with placebo.

Immune system disorders Rare:

Hypersensitivity reactions such as rash, itching and urticaria.

Metabolism and nutrition disorders Common:

Symptoms suggestive of hypoglycaemia.

Gastrointestinal disorders Common:

Abdominal pain, diarrhoea, dyspepsia, nausea.

Medicinal Product no longer authorised 7 Hepatobiliary disorders Rare:

Elevations in liver enzymes. Other events Other adverse events observed in clinical studies were of a similar incidence in Starlix-treated and placebo-treated patients. Post-marketing experience Post-marketing data revealed very rare cases of erythema multiforme.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

General Nateglinide should not be used in monotherapy. Hypoglycaemia Like other insulin secretagogues, nateglinide is capable of producing hypoglycaemia. 8). Elderly, malnourished patients and those with adrenal or pituitary insufficiency or severe renal impairment are more susceptible to the glucose- lowering effect of these treatments.

The risk of hypoglycaemia in type 2 diabetic patients may be increased by strenuous physical exercise, or ingestion of alcohol. 2) who have not undergone haemodialysis are more susceptible to the glucose-lowering effect of Starlix. Discontinuation should be considered in patients with severe renal impairment who present with potentiation of the hypoglycaemic effect.

5%). Combination with metformin is associated with an increased risk of hypoglycaemia compared to monotherapy. Hypoglycaemia may be difficult to recognise in subjects receiving beta blockers. 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.

At such times, it may be necessary to discontinue oral hypoglycaemic treatment and replace it with insulin on a temporary basis. Excipients Starlix contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or of glucose-galactose malabsorption should not take this medicinal product.

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’. Special populations Hepatic impairment Nateglinide should be used with caution in patients with moderate hepatic impairment.

Severe hepatic impairment, children and adolescents No clinical studies have been conducted in patients with severe hepatic impairment, or in children and adolescents. Medicinal Product no longer authorised 5

6)  Severe hepatic impairment