Levetiracetam Fair-Med Healthcare 750 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LEVETIRACETAM

Beschikbaar vanaf:

Fair-Med Healthcare GmbH Planckstraße 13 22765 HAMBURG (DUITSLAND)

ATC-code:

N03AX14

INN (Algemene Internationale Benaming):

LEVETIRACETAM

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CROSPOVIDON (E 1202) ; HYPROMELLOSE (E 464) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF ALUMINIUMLAK (E 110),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Levetiracetam

Product samenvatting:

Hulpstoffen: CROSPOVIDON (E 1202); HYPROMELLOSE (E 464); IJZEROXIDE ROOD (E 172); MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171); ZONNEGEEL FCF ALUMINIUMLAK (E 110);

Autorisatie datum:

2012-02-08

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_ _
LEVETIRACETAM FAIR-MED HEALTHCARE 250 MG, FILMOMHULDE TABLETTEN
LEVETIRACETAM FAIR-MED HEALTHCARE 500 MG, FILMOMHULDE TABLETTEN
LEVETIRACETAM FAIR-MED HEALTHCARE 750 MG, FILMOMHULDE TABLETTEN
LEVETIRACETAM FAIR-MED HEALTHCARE 1000 MG, FILMOMHULDE TABLETTEN
Levetiracetam
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
film-coated tabltes are an antiepileptic medicine (a
medicine used to
treat seizures in epilepsy).
is used alone in the treatment of partial seizures in
patients from 16
years of age.

is used in patients who are already taking another
antiepileptic
medicine_ _

in the treatment of partial seizures in adults, children and infants
from 1 month age

in the treatment of myoclonic seizures in adults and adolescents from
12 years of age
with juvenile myoclonic epilepsy.

in the treatment of primary generalised tonic-clonic seizures in
adults and adolescents
from 12 years of age
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE

If you are allergic ( hypersensitive) to levetiracetam or any of the
other ingredients of
this medicine (listed in Section 6).
WARNINGS AND PREC

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Levetiracetam Fair-Med Healthcare 250 mg, filmomhulde tabletten
Levetiracetam Fair-Med Healthcare 500 mg, filmomhulde tabletten
Levetiracetam Fair-Med Healthcare 750 mg, filmomhulde tabletten
Levetiracetam Fair-Med Healthcare 1000 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg levetiracetam.
Each film-coated tablet contains 500 mg levetiracetam.
Each film-coated tablet contains 750 mg levetiracetam.
Each film-coated tablet contains 1000 mg levetiracetam.
Excipients:
750 mg:
film-coated tablets contains 0.375 mg Sunset Yellow
Aluminium Lake
(E110)
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
250 mg: Blue, oval shaped film coated tablets with a break line on one
side with dimensions
12.9 x 6.1 mm. The tablet can be divided into equal halves.
500 mg: Yellow, oval shaped film coated tablets with a break line on
one side with
dimensions 16.5 x 7.7 mm. The tablet can be divided into equal halves.
750 mg: Orange, oval shaped film coated tablets with a break line on
one side with
dimensions 18.8 x 8.9 mm. The tablet can be divided into equal halves.
1000 mg: White, oval shaped film coated tablets with a break line on
one side with
dimensions 19.2 x 10.2 mm. The tablet can be divided into equal
halves.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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.
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 month of age with
epilepsy.

in the treatment of myoclonic seizures in adults and adolescents from
12 years of age
with Juvenile Myoclonic Epilepsy.

in the treatment of primary generalised