Riluzol Hexal 50 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

RILUZOL 50 mg/stuk

Beschikbaar vanaf:

Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)

ATC-code:

N07XX02

INN (Algemene Internationale Benaming):

RILUZOL 50 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Riluzole

Product samenvatting:

Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisatie datum:

2011-01-26

Bijsluiter

Hexal AG
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Riluzol Hexal 50 mg, filmomhulde tabletten
RVG106639
V8
1.3.1.3 Bijsluiter
Januari 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RILUZOL HEXAL
® 50 MG, FILMOMHULDE TABLETTEN
riluzole
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 illness 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
WHAT [NATIONALLY COMPLETED NAME] IS
The active substance in [nationally completed name] is riluzole which
acts on the nervous
system.
WHAT [NATIONALLY COMPLETED NAME] IS USED FOR
Hexal AG
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Riluzol Hexal 50 mg, filmomhulde tabletten
RVG106639
V8
1.3.1.3 Bijsluiter
Januari 2023
[nationally completed name] is used in patients with amyotrophic
lateral sclerosis (ALS).
ALS is a form of motor neurone disease where attacks of the nerve
cells responsible for
sending instructions to the muscles lead to weakness, muscle waste and
paralysis.
The destruction of nerve cells in motor neurone disease may be caused
by too much
glutamate (a chemical messenger) in the brain and spinal cord.
[nationally completed name]
stops the release of glutamate and this may help in preventing the
nerve cells being
damaged.
Please consult your doctor for more information about ALS and the
reason why this medicine
has been pr

Productkenmerken

Hexal AG
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Riluzol Hexal 50 mg, filmomhulde tabletten
RVG 106639
V6
1.3.1.1 Samenvatting van de Productkenmerken
Januari 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Riluzol Hexal 50 mg, filmomhulde tabletten
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of riluzole.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, film-coated, capsule shaped tablet with ‘RLZ’
debossed on one side and plain on
other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
[Nationally completed name] is indicated to extend life or the time to
mechanical ventilation for
patients with amyotrophic lateral sclerosis (ALS).
Clinical trials have demonstrated that [Nationally completed name]
extends survival for patients with
ALS (see section 5.1). Survival was defined as patients who were
alive, not intubated for mechanical
ventilation and tracheotomy-free.
There is no evidence that [Nationally completed name] exerts a
therapeutic effect on motor function,
lung function, fasciculations, muscle strength and motor symptoms.
[Nationally completed name] has
not been shown to be effective in the late stages of ALS.
Safety and efficacy of [Nationally completed name] has only been
studied in ALS. Therefore,
[Nationally completed name] should not be used in patients with any
other form of motor neurone
disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with [Nationally completed name] should only be initiated by
specialist physicians with
experience in the management of motor neurone diseases.
The recommended daily dose in adults or elderly is 100 mg (50 mg every
12 hours).
No significant increased benefit can be expected from higher daily
doses.
SPECIAL POPULATIONS
Hexal AG
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Riluzol Hexal 50 mg, filmomhulde tabletten
RVG 106639
V6
1.3.1.1 Samenvatting van de Productkenmerken
Januari 2023
Paediatric population:
[Nationally completed name] is not recommended for use in children,
due to a lack