Eslicarbazepine Acetaat Exeltis 600 mg tabletten

Страна: Нидерландия

Език: нидерландски

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

Активна съставка:

ESLICARBAZEPINEACETAAT 600 mg/stuk

Предлага се от:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

АТС код:

N03AF04

INN (Международно Name):

ESLICARBAZEPINEACETAAT 600 mg/stuk

Лекарствена форма:

Tablet

Композиция:

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

Начин на приложение:

Oraal gebruik

Терапевтична област:

Eslicarbazepine

Дата Оторизация:

1900-01-01

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
ESLICARBAZEPINE ACETAAT EXELTIS 200 MG, TABLETTEN
ESLICARBAZEPINE ACETAAT EXELTIS 400 MG, TABLETTEN
ESLICARBAZEPINE ACETAAT EXELTIS 600 MG, TABLETTEN
ESLICARBAZEPINE ACETAAT EXELTIS 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 IS AND WHAT IT IS USED FOR
contains the active substance eslicarbazepine acetate.
belongs to a group of medicines called antiepileptics
used to treat epilepsy, a condition
where
someone has repeated seizures or fits.
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).
has been given to you by your doctor to reduce your
number of seizures.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE :
•
if you are allergic to eslicarbazepine acetate, to other carboxamide
derivatives (e.g

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Eslicarbazepine Acetaat Exeltis 200 mg tabletten
Eslicarbazepine Acetaat Exeltis 400 mg tabletten
Eslicarbazepine Acetaat Exeltis 600 mg tabletten
Eslicarbazepine Acetaat Exeltis 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 600 mg of eslicarbazepine acetate.
Each tablet contains 800 mg of eslicarbazepine acetate.
[200 mg] Excipient(s) with known effect: sodium
1.05 mg.
[400 mg] Excipient(s) with known effect: sodium 2.19 mg.
[600 mg] Excipient(s) with known effect: sodium
3.26 mg.
[800 mg] Excipient(s) with known effect: sodium 4.34 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Eslicarbazepine Acetaat Exeltis 200 mg tabletten
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.
Eslicarbazepine Acetaat Exeltis 400 mg tabletten
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.
Eslicarbazepine Acetaat Exeltis 600 mg tabletten
White to off-white tablets, oblong and biconvex, with a break score on
both sides with a length of about
17.0 mm and a thickness of about 5.7 mm. The tablet can be divided
into equal doses.
Eslicarbazepine Acetaat Exeltis 800 mg tabletten
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
Eslicarbazepine Acetaat Exeltis is indicated as:
•
monotherapy in the treatment of partial-onset seizures, with or
without secondary
generalisation, in
adults with newly diagnosed epilepsy;
•
adj