Alprazolam Hexal 0,25 mg, tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

ALPRAZOLAM

Beschikbaar vanaf:

Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)

ATC-code:

N05BA12

INN (Algemene Internationale Benaming):

ALPRAZOLAM

farmaceutische vorm:

Tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; DOCUSAAT NATRIUM ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMBENZOAAT (E 211) ; SILICIUMDIOXIDE (E 551) ; ZETMEEL, GEPREGELATINEERD,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Alprazolam

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); DOCUSAAT NATRIUM; LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMBENZOAAT (E 211); SILICIUMDIOXIDE (E 551); ZETMEEL, GEPREGELATINEERD;

Autorisatie datum:

2008-10-14

Bijsluiter

Hexal AG
Page 1/9
Alprazolam Hexal 0,25/0,5/1,0 mg, tabletten
RVG 100489-100513-100515
1313-V11
1.3.1.3 Package Leaflet
Juni 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALPRAZOLAM HEXAL 0,25 MG, TABLETTEN
ALPRAZOLAM HEXAL 0,5 MG, TABLETTEN
ALPRAZOLAM HEXAL 1,0 MG, TABLETTEN
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 or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illnes are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [Nationally completed name]
is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT
[Nationally completed name] IS AND WHAT IT IS USED FOR
The active ingredient of [Nationally completed name] is alprazolam, a
triazolo benzodiazepine type
substance, which has anxiolytic, sedative-hypnotic, muscle relaxant
and seizure inhibiting effects.
[Nationally completed name] is used to treat
Anxiety states, anxiety with depression and associated with other
functional or organic diseases;
Panic disorder.
Alprazolam should only be used if the disorder is severe or is causing
invalidity, or if the patient is
experiencing inordinate suffering as a result of the disorder.”
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
[Nationally completed name]
DO NOT TAKE
[Nationally completed name]
:
•
if you are allergic to alprazolam or any of the other ingredients of
this medicine (listed in section 6), or
previously had an allergic reaction to another benzodiazepine
•
if you suffer from

Productkenmerken

Hexal AG
Page 1/13
Alprazolam Hexal 0,25/0,5/1,0 mg, tabletten
RVG 100489-100513-100515
1311-V10
1.3.1.1 Summary of Product Characteristics
Juni 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Alprazolam Hexal 0,25 mg, tabletten
Alprazolam Hexal 0,5 mg, tabletten
Alprazolam Hexal 1,0 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.25 mg of alprazolam.
Excipients with known effect
Each tablet contains 92.45 mg of lactose (as monohydrate) and 0.12 mg
of sodium benzoate.
Each tablet contains 0.5 mg of alprazolam.
Excipients with known effect
Each tablet contains 92.21 mg of lactose (as monohydrate) and 0.12 mg
of sodium benzoate.
Each tablet contains 1 mg of alprazolam.
Excipients with known effect
Each tablet contains 91.70 mg of lactose (as monohydrate) and 0.12 mg
of sodium benzoate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
_0.25 mg tablets: _
White, oblong tablet with a score line and debossed "APZM 0.25".
The tablet can be divided into equal doses.
_0.5 mg tablets: _
Pink, oblong tablet with a score line and debossed "APZM 0.5".
The tablet can be divided into equal doses.
_1 mg tablets: _
Light blue
_,_
oblong tablet with a score line and debossed "APZM 1".
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name]
is indicated for the treatment of
anxiety states, anxiety with
depression and associated with other functional or organic diseases;
Panic disorder
Hexal AG
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Alprazolam Hexal 0,25/0,5/1,0 mg, tabletten
RVG 100489-100513-100515
1311-V10
1.3.1.1 Summary of Product Characteristics
Juni 2020
[Nationally completed name] should only be used if the disorder is
severe or is causing
invalidity, or if the patient is experiencing inordinate suffering as
a result of the disorder.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The treatment period should be as short as possible. The total length
of treatment should not
exceed 8-12 weeks, including th