DRETACEN 750 mg, filmomhulde tabletten

País: Holanda

Língua: holandês

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

Ingredientes ativos:

LEVETIRACETAM

Disponível em:

Sandoz B.V.

Código ATC:

N03AX14

DCI (Denominação Comum Internacional):

LEVETIRACETAM

Forma farmacêutica:

Filmomhulde tablet

Composição:

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

Via de administração:

Oraal gebruik

Área terapêutica:

Levetiracetam

Resumo do produto:

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

Data de autorização:

2011-09-21

Folheto informativo - Bula

Sandoz B.V.
Page 1/11
Dretacen 250 / 500 / 75 / 1000 mg
RVG 108561-3-4-5
1311-V6
1.3.1.3 Bijsluiter
Maart 2019
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DRETACEN 250 MG, FILMOMHULDE TABLETTEN
DRETACEN 500 MG, FILMOMHULDE TABLETTEN
DRETACEN 750 MG, FILMOMHULDE TABLETTEN
DRETACEN 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 :
Sandoz B.V.
Page 2/11
Dretacen 250 / 500 / 75 / 1000 mg
RVG 108

Características técnicas

Sandoz B.V.
Page 1/21
Dretacen 250 / 500 / 75 / 1000 mg
RVG 108561-3-4-5
1311-V6
1.3.1.1 Samenvatting van de Productkenmerken
Maart 2019 SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
DRETACEN 250 mg, filmomhulde tabletten
DRETACEN 500 mg, filmomhulde tabletten
DRETACEN 750 mg, filmomhulde tabletten
DRETACEN 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.
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] _
Sandoz B.V.
Page 2/21
Dretacen 250 / 500 / 75 / 1000 mg
RVG 108561-3-4-5
1311-V6
1.3.1.1 Samenvatting van de Productkenmerken
Maart 2019
White, oval, biconvex film-coated tablets, scored on both sides,
debossed with LVT / 1000 on one
side.
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 or without secondary generalisation in adults and adolescents
from 16 years of age with newly
diagnosed epilepsy.
[Nationally completed name] is indicated as adjunctive therapy

in the treatment of partial onset seizures with or without secondary
generalisation in adults,
adolescents, children and infants from 1 m