Lacosamide STADA 100 mg, filmomhulde tabletten

Երկիր: Նիդերլանդեր

Լեզու: հոլանդերեն

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

Ակտիվ բաղադրիչ:

LACOSAMIDE 100 mg/stuk

Հասանելի է:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC կոդը:

N03AX18

INN (Միջազգային անվանումը):

LACOSAMIDE 100 mg/stuk

Դեղագործական ձեւ:

Filmomhulde tablet

Կազմը:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463a) ; HYPROLOSE (E 463) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; 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 GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Կառավարման երթուղին:

Oraal gebruik

Թերապեւտիկ տարածք:

Lacosamide

Ապրանքի ամփոփագիր:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463); HYPROLOSE (E 463); IJZEROXIDE GEEL (E 172); IJZEROXIDE ZWART (E 172); MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Հաստատման ամսաթիվը:

1900-01-01

Տեղեկատվական թերթիկ

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LACOSAMIDE STADA 50 MG, FILMOMHULDE TABLETTEN
LACOSAMIDE STADA 100 MG, FILMOMHULDE TABLETTEN
LACOSAMIDE STADA 150 MG, FILMOMHULDE TABLETTEN
LACOSAMIDE STADA 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 [Product Name] is and what it is used for
2. What you need to know before you take [Product Name]
3. How to take [Product Name]
4. Possible side effects
5. How to store [Product Name]
6. Contents of the pack and other information
1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
WHAT [PRODUCT NAME] IS
[Product Name] 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 [PRODUCT NAME] IS USED FOR
•
[Product Name] 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

Ապրանքի հատկությունները

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Lacosamide STADA 50 mg, filmomhulde tabletten
Lacosamide STADA 100 mg, filmomhulde tabletten
Lacosamide STADA 150 mg, filmomhulde tabletten
Lacosamide STADA 200 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
[Product Name] 50 mg film-coated tablets: Each film-coated tablet
contains 50 mg lacosamide.
[Product
Name]
100 mg
film-coated
tablets:
Each
film-coated
tablet
contains
100 mg
lacosamide.
[Product
Name]
150 mg
film-coated
tablets:
Each
film-coated
tablet
contains
150 mg
lacosamide.
[Product
Name]
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
[Product Name] 50 mg are pink, film coated oblong biconvex tablets,
embossed with “50” on
one side, plain on the other with 10.3 mm length and 4.8 mm width
approximately.
[Product Name] 100 mg are yellow, film coated oblong biconvex tablets,
embossed with “100”
on one side, plain on the other with 13.1 mm length and 6.1 mm width
approximately.
[Product Name] 150 mg are beige, film coated oblong biconvex tablets,
embossed with “150”
on one side, plain on the other with 15.2 mm length and 7.1 mm width
approximately.
[Product Name] 200 mg are blue, film coated oblong biconvex tablets,
embossed with “200”
on one side, plain on the other with 16.6 mm length and 7.7 mm width
approximately.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
[Product name] 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.
[Product name] 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 ye