Lacosamide Pharmascience International LTD 150 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LACOSAMIDE

Beschikbaar vanaf:

Pharmascience International Limited Julia House, Themistokli Dervi, 3 P.C. 1066 NICOSIA (CYPRUS)

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) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (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); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2018-04-25

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LACOSAMIDE PHARMASCIENCE INTERNATIONAL LTD 50 MG FILMOMHULDE TABLETTEN
LACOSAMIDE PHARMASCIENCE INTERNATIONAL LTD 100 MG FILMOMHULDE
TABLETTEN
LACOSAMIDE PHARMASCIENCE INTERNATIONAL LTD 150 MG FILMOMHULDE
TABLETTEN
LACOSAMIDE PHARMASCIENCE INTERNATIONAL LTD 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 Lacosamide Pharmascience International LTD is and what it is used
for
2.
What you need to know before you take Lacosamide Pharmascience
International LTD
3.
How to take Lacosamide Pharmascience International LTD
4.
Possible side effects
5.
How to store Lacosamide Pharmascience International LTD
6.
Contents of the pack and other information
1.
WHAT LACOSAMIDE PHARMASCIENCE INTERNATIONAL LTD IS AND WHAT IT IS USED
FOR
WHAT LACOSAMIDE PHARMASCIENCE INTERNATIONAL LTD IS
Lacosamide Pharmascience International LTD 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 LACOSAMIDE PHARMASCIENCE INTERNATIONAL LTD IS USED FOR

Lacosamide Pharmascience International LTD 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 the
brain.

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lacosamide Pharmascience International LTD 50 mg filmomhulde tabletten
Lacosamide Pharmascience International LTD 100 mg filmomhulde
tabletten
Lacosamide Pharmascience International LTD 150 mg filmomhulde
tabletten
Lacosamide Pharmascience International LTD 200 mg filmomhulde
tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg lacosamide.
Each film-coated tablet contains 100 mg lacosamide.
Each film-coated tablet contains 150 mg lacosamide.
Each film-coated tablet contains 200 mg lacosamide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Pink colored, oval, biconvex, coated tablets, debossed with “LAC”
on one side and ‘50’ on the other
side. Approximate dimension of the tablets: Length=10.30 mm;
Width=4.80 mm; Thickness=3.30
mm.
Yellow colored, oval, biconvex, coated tablets, debossed with
“LAC” on one side and ‘100’ on the
other side. Approximate dimension of the tablets: Length=13.10 mm;
Width=6.00 mm;
Thickness=4.10 mm
Salmon colored, oval, biconvex, coated tablets, debossed with”LAC”
on one side and ‘150’ on the
other side. Aproximate dimension of the tablets: Length=15.00 mm;
Width=7.00 mm; Thickness=4.60
mm
Blue colored, oval, biconvex, coated tablets debossed with “LAC”
on one side and ‘200’ on the other
side. Approximate dimension of the tablets: Length=16.50 mm;
Width=7.60 mm; Thickness=5.30 mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lacosamide Pharmascience International LTD 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 in