Lacosamide Helm 100 mg filmomhulde tabletten

Pajjiż: Olanda

Lingwa: Olandiż

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

Ingredjent attiv:

LACOSAMIDE

Disponibbli minn:

Helm AG Nordkanalstrasse 28 20097 HAMBURG (DUITSLAND)

Kodiċi ATC:

N03AX18

INN (Isem Internazzjonali):

LACOSAMIDE

Għamla farmaċewtika:

Filmomhulde tablet

Kompożizzjoni:

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),

Rotta amministrattiva:

Oraal gebruik

Żona terapewtika:

Lacosamide

Sommarju tal-prodott:

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);

Data ta 'l-awtorizzazzjoni:

2017-11-22

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Lacosamide Helm 50 mg filmomhulde tabletten
Lacosamide Helm 100 mg filmomhulde tabletten
Lacosamide Helm 150 mg filmomhulde tabletten
Lacosamide Helm 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 Helm
is and what it is used for
2.
What you need to know before you take
Lacosamide Helm
3.
How to take
Lacosamide Helm
4.
Possible side effects
5.
How to store
Lacosamide Helm
6.
Contents of the pack and other information
1.
WHAT
LACOSAMIDE HELM IS AND WHAT IT IS USED FOR
WHAT LACOSAMIDE HELMIS
Lacosamide Helm 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 Helm is used for
•
Lacosamide Helm 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.
•
Lacosamide Helm may be used on its own or with other antiepileptic
medicines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LACOSAMIDE HELM
DO NOT TAKE
LACOSAMIDE HELM
-
if you are allergic to lacosamide, or any of the other ingredients of
this medicine (listed in
Section 6). If you ar

Karatteristiċi tal-prodott

1.
NAME OF THE MEDICINAL PRODUCT
Lacosamide Helm 50 mg filmomhulde tabletten
Lacosamide Helm 100 mg filmomhulde tabletten
Lacosamide Helm 150 mg filmomhulde tabletten
Lacosamide Helm 200 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lacosamide Helm 50 mg film-coated tablets
Each film-coated tablet contains 50 mg lacosamide.
Lacosamide Helm 100 mg film-coated tablets
Each film-coated tablet contains 100 mg lacosamide.
Lacosamide Helm 150 mg film-coated tablets
Each film-coated tablet contains 150 mg lacosamide.
Lacosamide Helm 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
Lacosamide Helm 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.
Lacosamide Helm 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.
Lacosamide Helm 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.
Lacosamide Helm 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
Lacosamide Helm
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