Cosim 200 mg filmomhulde tabletten

Land: Nederländerna

Språk: nederländska

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

Aktiva substanser:

LACOSAMIDE 200 mg/stuk

Tillgänglig från:

Gedeon Richter Plc. Gyömröi út 19-21 1103 BUDAPEST (HONGARIJE)

ATC-kod:

N03AX18

INN (International namn):

LACOSAMIDE 200 mg/stuk

Läkemedelsform:

Filmomhulde tablet

Sammansättning:

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

Administreringssätt:

Oraal gebruik

Terapiområde:

Lacosamide

Produktsammanfattning:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463); HYPROLOSE (E 463); INDIGOKARMIJN ALUMINIUMLAK (E 132); MAGNESIUMSTEARAAT (E 470b); POLYETHYLEENGLYCOL (E 1521); POLYVINYLALCOHOL (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Tillstånd datum:

2018-04-25

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COSIM 50 MG FILMOMHULDE TABLETTEN
COSIM 100 MG FILMOMHULDE TABLETTEN
COSIM 150 MG FILMOMHULDE TABLETTEN
COSIM 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
Cosim
is and what it is used for
2.
What you need to know before you take
Cosim
3.
How to take
Cosim
4.
Possible
side
effects
5.
How to store
Cosim
6.
Contents of the pack and other information
1.
WHAT
COSIM IS AND WHAT IT IS USED FOR
WHAT COSIM IS
Cosim 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 COSIM IS USED FOR
•
It 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.
WHAT YOU NEED TO KN

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cosim 50 mg filmomhulde tabletten
Cosim 100 mg filmomhulde tabletten
Cosim 150 mg filmomhulde tabletten
Cosim 200 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cosim 50 mg film-coated tablets
Each film-coated tablet contains 50 mg lacosamide.
Cosim 100 mg film-coated tablets
Each film-coated tablet contains 100 mg lacosamide.
Cosim 150 mg film-coated tablets
Each film-coated tablet contains 150 mg lacosamide.
Cosim 200 mg film-coated tablets
Each film-coated tablet contains 200 mg lacosamide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Cosim 50 mg film-coated tablets
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.
Cosim 100 mg film-coated tablets
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.
Cosim 150 mg film-coated tablets
Salmon, oval film-coated tablets with approximate dimensions of 15 mm
x 7 mm and debossed
with ‘LAC’ on one side and ‘150’ on the other side.
Cosim 200 mg film-coated tablets
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
Cosim
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.
Lacosamide 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.
4.2
POSOLOGY AND METHOD OF