Eslicarbazepine acetaat STADA 200 mg tabletten

Land: Holland

Sprog: hollandsk

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

Aktiv bestanddel:

ESLICARBAZEPINEACETAAT

Tilgængelig fra:

Stada Arzneimittel AG

ATC-kode:

N03AF04

INN (International Name):

ESLICARBAZEPINEACETAAT

Lægemiddelform:

Tablet

Sammensætning:

CROSCARMELLOSE NATRIUM (E 468) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201)

Indgivelsesvej:

Oraal gebruik

Terapeutisk område:

Eslicarbazepine

Autorisation dato:

2019-08-28

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
Eslicarbazepine acetaat STADA 200 mg tabletten
Eslicarbazepine acetaat STADA 400 mg tabletten
Eslicarbazepine acetaat STADA 800 mg tabletten
Eslicarbazepine acetate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD 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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT ESLICARBAZEPINE ACETATE STADA 200 MG, 400 MG, 800 MG IS AND WHAT
IT IS USED FOR
Eslicarbazepine acetate STADA 200 mg, 400 mg, 800 mg contains the
active substance eslicarbazepine
acetate.
Eslicarbazepine acetate STADA 200 mg, 400 mg, 800 mg belongs to a
group of medicines called
antiepileptics used to treat epilepsy, a condition where
someone has repeated seizures or fits.
Eslicarbazepine acetate STADA 200 mg, 400 mg, 800 mg is used:

on its own (monotherapy) in adult patients with newly diagnosed
epilepsy

with other antiepileptic medicines (adjunctive therapy), in adult,
adolescents and children patients
above 6 years of age, who are experiencing seizures that affect one
part of the brain (partial
seizure). These seizures may or may not be followed by a seizure
affecting all of the brain
(secondary
generalisation).
Eslicarbazepine acetate STADA 200 mg, 400 mg, 800 mg has been given to
you by your doctor to reduce
your number of seizures.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE

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Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Eslicarbazepine acetaat STADA 200 mg tabletten
Eslicarbazepine acetaat STADA 400 mg tabletten
Eslicarbazepine acetaat STADA 800 mg tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of eslicarbazepine acetate.
Each tablet contains 400 mg of eslicarbazepine acetate.
Each tablet contains 800 mg of eslicarbazepine acetate.
Excipient with known effect
[200 mg] : Each tablet contains 1,09 mg sodium
[400 mg] : Each tablet contains 2,17 mg sodium
[800 mg] : Each tablet contains 4,35 mg sodium
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
200 mg tablets
White to off-white tablets, oblong and biconvex, with a break score on
both sides with a length of about
11.8 mm and a thickness of about 3.9 mm. The tablet can be divided
into equal doses.
400 mg tablets
White to off-white tablets, oblong and biconvex, with a break score on
both sides with a length of about
15.0 mm and a thickness of about 4.9 mm. The tablet can be divided
into equal doses.
800 mg tablets
White to off-white tablets, oblong and biconvex, with a break score on
both sides with a length of about
18.9 mm and a thickness of about 6.1 mm. The tablet can be divided
into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
is indicated as:

monotherapy in the treatment of partial-onset seizures, with or
without secondary generalisation,
in
adults with newly diagnosed epilepsy;

adjunctive therapy in adults, adolescents and children aged above 6
years, with
partial-onset
seizures with or without secondary generalisation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
may be taken as monotherapy or added to existing
anticonvulsant therapy. The
recommended starting dose is 400 mg once daily which should be
increased to 800 mg once daily after
one or two weeks. Based on individual response, the dose may be
increased to 1,200 m