Alprazolam 2care4 0,5 mg Depottablett

País: Suècia

Idioma: suec

Font: Läkemedelsverket (Medical Products Agency)

ingredients actius:

alprazolam

Disponible des:

2care4 ApS

Codi ATC:

N05BA12

Designació comuna internacional (DCI):

alprazolam

Dosis:

0,5 mg

formulario farmacéutico:

Depottablett

Composición:

laktosmonohydrat Hjälpämne; alprazolam 0,5 mg Aktiv substans

tipo de receta:

Receptbelagt

Área terapéutica:

Alprazolam

Estat d'Autorització:

Avregistrerad

Data d'autorització:

2014-01-21

Fitxa tècnica

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