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 100533-100535-100543
1311-V9
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.
Content of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME]
IS AND WHAT IT IS USED FOR
[Nationally completed name] is a tranquilliser containing the active
substance alprazolam. Alprazolam
belongs to one of a group of medicines called benzodiazepines.
Benzodiazepines affect chemical activity in
the brain to promote sleep and to reduce anxiety and worry.
[Nationally completed name] is used to
TREAT ANXIETY
that is severe, disabling or causing the sufferer great
distress.
[Nationally completed name] tablets should only be used for short-term
treatment of anxiety. The overall
duration of treatment should not be more than 12 weeks including a
period where the dose is gradually
reduced (this is called dose ‘tapering’).
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

Productkenmerken

Hexal AG
Page 1/13
Alprazolam Hexal 0,25/0,5/1,0 mg, tabletten
RVG 100533-100535-100543
1311-V8
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 92.5 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 92.2 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 91.7 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 tablet: _
White, oblong tablet with a score line and debossed "APZM 0.25".
The tablet can be divided into equal doses.
_0.5 mg tablet: _
Pink, oblong tablet with a score line and debossed "APZM 0.5".
The tablet can be divided into equal doses.
_1 mg tablet: _
Light blue
_,_
oblong tablet with a score line and debossed “APZM 1”.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
Hexal AG
Page 2/13
Alprazolam Hexal 0,25/0,5/1,0 mg, tabletten
RVG 100533-100535-100543
1311-V8
1.3.1.1 Summary of Product Characteristics
Juni 2020
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of anxiety.
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.
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 the period of gradual dose reduction.
Prolonged treatment may
be necessary in certain circumstances, but this should not be done
until the patient’s
condition has