Levetiracetam AMETAS 750 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LEVETIRACETAM 750 mg/stuk

INN (Algemene Internationale Benaming):

LEVETIRACETAM 750 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

IJZEROXIDE ROOD (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF ALUMINIUMLAK (E 110)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE
PATIENT
LEVETIRACETAM AMETAS 250 MG, FILMOMHULDE TABLETTEN
LEVETIRACETAM AMETAS 500 MG, FILMOMHULDE TABLETTEN
LEVETIRACETAM AMETAS 750 MG, FILMOMHULDE TABLETTEN
LEVETIRACETAM AMETAS 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 Levetiracetam AMETAS is and what it is used for
2.
What you need to know before you take Levetiracetam AMETAS
3.
How to take Levetiracetam AMETAS
4.
Possible side effects
5.
How to store Levetiracetam AMETAS
6.
Contents of the pack and other information
1.
WHAT LEVETIRACETAM AMETAS IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Levetiracetam AMETAS 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:

partial onset seizures with or without generalisation in adults,
adolescents, children
and infants from one month of age;

myoclonic seizures (short, shock-like jerk

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Levetiracetam AMETAS 250 mg, filmomhulde tabletten
Levetiracetam AMETAS 500 mg, filmomhulde tabletten
Levetiracetam AMETAS 750 mg, filmomhulde tabletten
Levetiracetam AMETAS 1000 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Levetiracetam AMETAS 250 mg film-coated tablets _
Each film-coated tablet contains 250 mg levetiracetam.
_Levetiracetam AMETAS 500 mg film-coated tablets _
Each film-coated tablet contains 500 mg levetiracetam.
_Levetiracetam AMETAS 750 mg film-coated tablets _
Each film-coated tablet contains 750 mg levetiracetam.
Excipient with known effect: Each film-coated tablet contains 0.17 mg
of sunset yellow FCF
(E110).
_Levetiracetam AMETAS 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.
_Levetiracetam AMETAS 250 mg film-coated tablets _
Blue coloured, capsule shaped tablets (12.7 x 5.9 mm) with deep notch
on one side.
The tablets can be divided into equal halves.
_Levetiracetam AMETAS 500 mg film-coated tablets _
Yellow coloured, capsule shaped tablets (16.3 x 7.6 mm) with deep
notch on one side.
The tablets can be divided into equal halves.
_Levetiracetam AMETAS 750 mg film-coated tablets_
Orange coloured, capsule shaped tablets (18.6 x 8.65 mm) with deep
notch on one side.
The tablets can be divided into equal halves.
_Levetiracetam AMETAS 1000 mg film-coated tablets_
White coloured, capsule shaped tablets (19.1 x 10.2 mm) with deep
notch on one side.
The tablets can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levetiracetam AMETAS 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.
Levetiracetam AMETAS is indicated as adjunctive therapy
•
in the treatment of partial onset seizures with or without secondary