Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GLIMEPIRIDE
Sanofi-Aventis Ireland Limited
4.0mg Milligram
Tablets
2000-07-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amaryl 4 mg tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4 mg glimepiride. Excipients: also contains 135.9 mg lactose monohydrate per tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet The tablets are light blue, oblong and scored on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amaryl is indicated for the treatment of type 2 diabetes mellitus, when diet, physical exercise and weight reduction alone are not adequate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration The basis for successful treatment of diabetes is a good diet, regular physical activity, as well as routine checks of blood and urine. Tablets or insulin cannot compensate if the patient does not keep to the recommended diet. Dosage is determined by the results of blood and urinary glucose determinations. The starting dose is 1 mg glimepiride per day. If good control is achieved this dosage should be used for maintenance therapy. For the different dosage regimens appropriate strengths are available. If control is unsatisfactory the dosage should be increased, based on the glycaemic control, in a stepwise manner with an interval of about 1 to 2 weeks between each step, to 2, 3 or 4 mg glimepiride per day. A dosage of more than 4 mg glimepiride per day gives better results only in exceptional cases. The maximum recommended dose is 6 mg glimepiride per day. In patients not adequately controlled with the maximum daily dose of metformin, concomitant glimepiride therapy can be initiated. While maintaining the metformin dose, the glimepiride therapy is started with a low dose, and is then titrated up depending on the desired level of metabolic cont Read the complete document