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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amaryl 4mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4mg glimepiride.
_For excipients, see 6.1_
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from Spain and Germany:_
Light blue, oblong tablets with ’NMO’, a logo and a breakline 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
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.
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, glimepiride therapy is started with a low dose, and is then titrated up depending
on the desired level of metabolic control up to the maximum daily dose. The combination therapy should be initiated
under close medical supervision.
In pati
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