Levetiracetam Hexal 500 mg, filmomhulde tabletten

Maa: Alankomaat

Kieli: hollanti

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

Aktiivinen ainesosa:

LEVETIRACETAM 500 mg/stuk

Saatavilla:

Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)

ATC-koodi:

N03AX14

INN (Kansainvälinen yleisnimi):

LEVETIRACETAM 500 mg/stuk

Lääkemuoto:

Filmomhulde tablet

Koostumus:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 600 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 600 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Antoreitti:

Oraal gebruik

Terapeuttinen alue:

Levetiracetam

Tuoteyhteenveto:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); CROSPOVIDON (E 1202); HYPROLOSE (E 463); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); MACROGOL 600; MAGNESIUMSTEARAAT (E 470b); POVIDON K 25 (E 1201); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Valtuutus päivämäärä:

2011-09-21

Pakkausseloste

Hexal AG
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Levetiracetam Hexal 250/500/750/1000 mg
RVG 108534-7-8-9
1313-v10
1.3.1.3 Bijsluiter
September 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVETIRACETAM HEXAL 250 MG, FILMOMHULDE TABLETTEN
LEVETIRACETAM HEXAL 500 MG, FILMOMHULDE TABLETTEN
LEVETIRACETAM HEXAL 750 MG, FILMOMHULDETABLETTEN LEVETIRACETAM HEXAL 1000 MG, FILMOMHULDE TABLETTEN
levetiracetam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD 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. Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR _ _
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
[Nationally completed name] is used:
•
on its own in adults and adolescents from 16 years of age with newly
diagnosed epilepsy, to treat
a certain form of epilepsy. Epilepsy is a condition where the patients
have repeated fits (seizures).
Levetiracetam is used for the epilepsy form in which the fits
initially affect only one side of the
brain, but could thereafter extend to larger areas on both sides of
the brain (partial onset seizure
with or without secondary generalisation). Levetiracetam has been
given to you by your doctor to
reduce the number of fits.
•
as an add-on to other antiepileptic medicines to treat :
o
partial on

Valmisteyhteenveto

Hexal AG
Page 1/21
Levetiracetam Hexal 250/500/750/1000 mg
RVG 108534-7-8-9
1311-v10
1.3.1.1 Samenvatting van de Productkenmerken
September 2023 SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levetiracetam Hexal 250 mg, filmomhulde tabletten
Levetiracetam Hexal 500 mg, filmomhulde tabletten
Levetiracetam Hexal 750 mg, filmomhulde tabletten
Levetiracetam Hexal 1000 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_250 mg film-coated tablets:_
Each film-coated tablet contains 250 mg levetiracetam.
_500 mg film-coated tablets:_
Each film-coated tablet contains 500 mg levetiracetam.
_750 mg film-coated tablets:_
Each film-coated tablet contains 750 mg levetiracetam.
_1000 mg film-coated tablets:_
Each film-coated tablet contains 1000 mg levetiracetam.
_1500 mg film-coated tablets: _
Each film-coated tablet contains 1500 mg levetiracetam.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_[250 mg film-coated tablets] _
Light blue, oval, biconvex film-coated tablets, scored on both sides,
debossed with ‘LVT / 250’ on one
side.
_[500 mg film-coated tablets] _
Yellow, oval, biconvex film-coated tablets, scored on both sides,
debossed with ‘LVT / 500’ on one
side.
_[750 mg film-coated tablets] _
Apricot color, oval, biconvex film-coated tablets, scored on both
sides, debossed with ‘LVT / 750’ on
one side.
_[1000 mg film-coated tablets] _
White, oval, biconvex film-coated tablets, scored on both sides,
debossed with ‘LVT / 1000’ on one
side.
Hexal AG
Page 2/21
Levetiracetam Hexal 250/500/750/1000 mg
RVG 108534-7-8-9
1311-v10
1.3.1.1 Samenvatting van de Productkenmerken
September 2023
_[1500 mg film-coated tablets] _
Green, oval shaped, film-coated tablets, scored on one side. The
dimensions of the tablets are 21.6 mm
x 11.4 mm.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] is indicated as monotherapy in the
treatment of partial onset seizures
with