Land: Sverige
Språk: svenska
Källa: Läkemedelsverket (Medical Products Agency)
alprazolam
2care4 ApS
N05BA12
alprazolam
0,5 mg
Depottablett
laktosmonohydrat Hjälpämne; alprazolam 0,5 mg Aktiv substans
Receptbelagt
Alprazolam
Avregistrerad
2014-01-21
SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Alprazolam Krka 0.5 mg prolonged-release tablets Alprazolam Krka 1 mg prolonged-release tablets Alprazolam Krka 2 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 0.5 mg alprazolam. Each prolonged-release tablet contains 1 mg alprazolam. Each prolonged-release tablet contains 2 mg alprazolam. Excipient with known effect: 0.5 mg tablets 1 tablets 2 mg tablets Lactose 183.74 mg 183.69 mg 182.93 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet. _0.5 mg:_ greenish-yellow, round, slightly biconvex. _1 mg:_ white, round, slightly biconvex. _2 mg:_ light blue, round, slightly biconvex. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alprazolam is indicated for short-term symptomatic treatment of anxiety in adults. Alprazolam is only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY If possible, treatment should be started, monitored and finished by the same doctor. Symptomatic treatment of anxiety _:_ Pharmacological therapy of anxiety should always be adjuvant. _ _ Initial dose 0.5 mg once daily, adjusted individually. Maintenance dosage is 0.5–3 mg/day in one or two divided doses. For elderly patients, patients with impaired hepatic or renal function and those sensitive to the sedative effects of the product, the initial and maintenance dose is 0.5 - 1 mg daily. Dosage may be increased gradually where necessary. It is recommended that daily doses greater than 3 mg be taken in two divided doses. In elderly patients, if too high doses are used, confusion can occur. Duration of treatment: Alprazolam should be used in the lowest possible effective dose, for the shortest possible time and for a maximum of 2-4 weeks. The need for continued treatment should be reassessed frequently. Long-term treatment is n Läs hela dokumentet