Zilibra 50 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LACOSAMIDE 50 mg/stuk

Beschikbaar vanaf:

Pharmaceutical Works Polpharma S.A. 19, Pelplinska Street 83-200 STAROGARD GDANSKI (POLEN)

ATC-code:

N03AX18

INN (Algemene Internationale Benaming):

LACOSAMIDE 50 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463a) ; HYPROLOSE (E 463) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; POLYETHYLEENGLYCOL (E 1521) ; POLYVINYLALCOHOL (E 1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROLOSE (E 463) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; POLYETHYLEENGLYCOL (E 1521) ; POLYVINYLALCOHOL (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Lacosamide

Autorisatie datum:

2018-04-18

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Zilibra 50 mg filmomhulde tabletten
Zilibra 100 mg filmomhulde tabletten
Zilibra 150 mg filmomhulde tabletten
Zilibra 200 mg filmomhulde tabletten
Lacosamide
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
Zilibra
is and what it is used for
2.
What you need to know before you take
Zilibra
3.
How to take
Zilibra
4.
Possible side effects
5.
How to store
Zilibra
6.
Contents of the pack and other information
1.
WHAT
ZILIBRA IS AND WHAT IT IS USED FOR
WHAT ZILIBRA IS
Zilibra contains lacosamide. This belongs to a group of medicines
called “antiepileptic medicines”.
These medicines are used to treat epilepsy.
-
You have been given this medicine to lower the number of fits
(seizures) you have.
WHAT ZILIBRA IS USED FOR
Zilibra is used:
-
on its own and in association with other antiepileptic medicines in
adults, adolescents and
children aged 2 years and older to treat a certain type of epilepsy
characterised by the
occurrence of partial-onset seizure with or without secondary
generalisation. In this type of
epilepsy, fits first affect only one side of your brain. However,
these may then spread to
larger areas on both sides of your brain;
-
in association with other antiepileptic medicines in adults,
adolescents and children aged
4 years and older to treat primary generalised tonic-clonic seizures
(major fits, including loss
of consciousness) in patients with idiopathic generalised epilepsy
(the type of epilepsy that is
thought to have a genetic cause).
2

Productkenmerken

1
1.
NAME OF THE MEDICINAL PRODUCT
Zilibra 50 mg filmomhulde tabletten
Zilibra 100 mg filmomhulde tabletten
Zilibra 150 mg filmomhulde tabletten
Zilibra 200 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zilibra 50 mg filmomhulde tabletten
Each film-coated tablet contains 50 mg lacosamide.
Zilibra 100 mg
filmomhulde tabletten
Each film-coated tablet contains 100 mg lacosamide.
Zilibra 150 mg
filmomhulde tabletten
Each film-coated tablet contains 150 mg lacosamide.
Zilibra 200 mg
filmomhulde tabletten
Each film-coated tablet contains 200 mg lacosamide.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Zilibra 50 mg filmomhulde tabletten
Pinkish, oval film-coated tablets with approximate dimensions of 10 mm
x 5 mm and debossed
with ‘LAC’ on one side and ‘50’ on the other side.
Zilibra 100 mg
filmomhulde tabletten
Dark yellow, oval film-coated tablets with approximate dimensions of
13 mm x 6 mm and
debossed with‘LAC’ on one side and ‘100’ on the other side.
Zilibra 150 mg
filmomhulde tabletten
Salmon, oval film-coated tablets with approximate dimensions of15 mm x
7 mm and debossed
with ‘LAC’ on one side and ‘150’ on the other side.
Zilibra 200 mg
filmomhulde tabletten
Blue, oval film-coated tablets with approximate dimensions of 16.5 mm
x 7.5 mm and debossed
with ‘LAC’ on one side and ‘200’ on the other side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Zilibra
is indicated as monotherapy in the treatment of partial-onset seizures
with or without
secondary generalisation in adults, adolescents and children from 2
years of age with epilepsy.
Zilibra
is indicated as adjunctive therapy
-
in the treatment of partial-onset seizures with or without secondary
generalisation in adults,
adolescents and children from 2 years of age with epilepsy.
-
in the treatment of primary generalised tonic-clonic seizures in
adults, adolescents and
children from 4 years of age with idiopathic generalised epilepsy.
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The physician shoul