Alprazolam 2care4 1 mg Depottablett

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

alprazolam

Available from:

2care4 ApS

ATC code:

N05BA12

INN (International Name):

alprazolam

Dosage:

1 mg

Pharmaceutical form:

Depottablett

Composition:

alprazolam 1 mg Aktiv substans; laktosmonohydrat Hjälpämne

Class:

Apotek

Prescription type:

Receptbelagt

Therapeutic area:

Alprazolam

Authorization status:

Avregistrerad

Authorization date:

2014-01-21

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALPRAZOLAM KRKA 0.5 MG PROLONGED-RELEASE TABLETS
ALPRAZOLAM KRKA 1 MG PROLONGED-RELEASE TABLETS
ALPRAZOLAM KRKA 2 MG PROLONGED-RELEASE TABLETS
alprazolam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Alprazolam Krka is and what it is used for
2.
What you need to know before you take Alprazolam Krka
3.
How to take Alprazolam Krka
4.
Possible side effects
5.
How to store Alprazolam Krka
6.
Contents of the pack and other information
1.
WHAT ALPRAZOLAM KRKA IS AND WHAT IT IS USED FOR
The active ingredient is alprazolam. It belongs to the group of
medicines called benzodiazepines
(anxiety-relieving medicines).
Alprazolam Krka tablets are used in adults for treatment of anxiety
symptoms which are severe,
disabling or causing the patient great distress. This medicine is for
short-term use only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALPRAZOLAM KRKA
DO NOT TAKE ALPRAZOLAM KRKA IF YOU
-
are allergic to alprazolam, other benzodiazepines or any of the other
ingredients of this medicine
(listed in section 6)
-
have been diagnosed with
_myasthenia gravis_
(a disease causing muscle weakness)
-
suffer from severe respiratory failure
-
have sleep apnoea syndrome (prolonged transient cessations of
breathing during sleep)
-
suffer from severe liver insufficiency.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Alprazolam Krka tablets, if you
-
notice that the effect of the tablets will weaken after you have used
them several we

Summary of Product characteristics

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