DRETACEN 1500 mg, filmomhulde tabletten

Země: Nizozemsko

Jazyk: nizozemština

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

Aktivní složka:

LEVETIRACETAM 1500 mg/stuk

Dostupné s:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

INN (Mezinárodní Name):

LEVETIRACETAM 1500 mg/stuk

Léková forma:

Filmomhulde tablet

Složení:

CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Podání:

Oraal gebruik

Datum autorizace:

1900-01-01

Informace pro uživatele

Sandoz B.V.
Page 1/12
Dretacen 250, 500, 1000, 1500 mg, filmomhulde tabletten
RVG 108561-3-5-126275
1313-V10
1.3.1.3 Bijsluiter
September 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DRETACEN 250 MG, FILMOMHULDE TABLETTEN
DRETACEN 500 MG, FILMOMHULDE TABLETTEN
DRETACEN 1000 MG, FILMOMHULDE TABLETTEN
DRETACEN 1500 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 onset seizures with

Charakteristika produktu

Sandoz B.V.
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Dretacen 250, 500, 1000 mg, filmomhulde tabletten
RVG 108561-3-5
V12
1.3.1.1 Samenvatting van de Productkenmerken
Februari 2024 SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
DRETACEN 250 mg, filmomhulde tabletten
DRETACEN 500 mg, filmomhulde tabletten
DRETACEN 1000 mg, filmomhulde tabletten
DRETACEN 1500 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.
Sandoz B.V.
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Dretacen 250, 500, 1000 mg, filmomhulde tabletten
RVG 108561-3-5
V12
1.3.1.1 Samenvatting van de Productkenmerken
Februari 2024
_[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 or without secondary generalisat