Lacoala 100 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LACOSAMIDE

Beschikbaar vanaf:

Helm AG Nordkanalstrasse 28 20097 HAMBURG (DUITSLAND)

ATC-code:

N03AX18

INN (Algemene Internationale Benaming):

LACOSAMIDE

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROLOSE (E 463) ; IJZEROXIDE GEEL (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; POLYETHYLEENGLYCOL (E 1521) ; POLYVINYLALCOHOL (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Lacosamide

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463); HYPROLOSE (E 463); IJZEROXIDE GEEL (E 172); MAGNESIUMSTEARAAT (E 470b); POLYETHYLEENGLYCOL (E 1521); POLYVINYLALCOHOL (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2017-11-22

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Lacoala 50 mg filmomhulde tabletten
Lacoala 100 mg filmomhulde tabletten
Lacoala 150 mg filmomhulde tabletten
Lacoala 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
Lacoala
is and what it is used for
2.
What you need to know before you take
Lacoala
3.
How to take
Lacoala
4.
Possible side effects
5.
How to store
Lacoala
6.
Contents of the pack and other information
1.
WHAT
LACOALA IS AND WHAT IT IS USED FOR
WHAT LACOALAIS
Lacoala 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 Lacoala is used for
•
Lacoala is used in adults, adolescents and children aged 4 years and
older.
•
It is used to treat a certain type of epilepsy called “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.
•
Lacoala may be used on its own or with other antiepileptic medicines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LACOALA
DO NOT TAKE
LACOALA
-
if you are allergic to lacosamide, or any of the other ingredients of
this medicine (listed in
Section 6). If you are not sure whether you are allergic, please
discuss with your doctor
-
if you have a certain type of heart beat problem called s

Productkenmerken

1.
NAME OF THE MEDICINAL PRODUCT
Lacoala 50 mg filmomhulde tabletten
Lacoala 100 mg filmomhulde tabletten
Lacoala 150 mg filmomhulde tabletten
Lacoala 200 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lacoala 50 mg film-coated tablets
Each film-coated tablet contains 50 mg lacosamide.
Lacoala 100 mg film-coated tablets
Each film-coated tablet contains 100 mg lacosamide.
Lacoala 150 mg film-coated tablets
Each film-coated tablet contains 150 mg lacosamide.
Lacoala 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
Lacoala 50 mg film-coated tablets
Pinkish, oval film-coated tablets with a size of appr. 10 mm x 5 mm,
marked with ‘LAC’ on one
side and ‘50’ on the other side.
Lacoala 100 mg film-coated tablets
Dark yellow, oval film-coated tablets with a size of appr. 13 mm x 6
mm, marked with ‘LAC’
on one side and ‘100’ on the other side.
Lacoala 150 mg film-coated tablets
Salmon, oval film-coated tablets with a size of appr. 15 mm x 7 mm,
marked with ‘LAC’ on one
side and ‘150’ on the other side.
Lacoala 200 mg film-coated tablets
Blue, oval film-coated tablets with a size of appr. 16.5 mm x 7.5 mm,
marked with ‘LAC’ on
one side and ‘200’ on the other side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Lacoala
is indicated as monotherapy and adjunctive therapy in the treatment of
partial-onset seizures
with or without secondary generalisation in adults, adolescents and
children from 4 years of age with
epilepsy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Lacosamide must be taken twice a day (usually once in the morning and
once in the evening).
Lacosamide may be taken with or without food.
If a dose is missed, the patient should be instructed to take the
missed dose immediately, and then
to
take the next dose of lacosamide at the regularly scheduled time. If
the patient notices the
missed dose
within 6 hours of the next one, he/s