Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
ALPRAZOLAM
Helsinn Birex Therapeutics Ltd
0.5mg Milligram
Tablets
2009-05-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calmax 0.5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.5mg of Alprazolam. Excipients: Each tablet contains 97.06mg of Lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. Pink, oblong tablets embossed with “apzm 0.5” and a breakline. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Anxiety Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Anxiety Treatment should be as short as possible. The overall duration of treatment generally should not be more than 8-12 weeks, including a tapering off process. The patient should be reassessed regularly and the need for continued treatment should be evaluated, especially in case the patient is symptom free. It is usual to commence with a dose of 500 mcg to 1 mg daily in divided doses, with increments (no greater than 1 mg every 3-4 days), to the level of optimal control usually 3 to 4 mg daily. In the elderly or debilitated patient a regimen of 250 mcg twice daily should be used initially with gradual increments if required and tolerance is assured. Treatment should be started with the lower recommended dose. The maximum dose should not be exceeded. Initial doses may be given at bedtime to minimise daytime lethargy. If side effects occur with the starting dose, the dose should be lowered. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient's status. IRISH MEDICINES BOARD _________________________________________________________________________________________________________________ Les hele dokumentet