Zebinix
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
14-03-2022
Fachinformation
(SPC)
14-03-2022
Öffentlichen Beurteilungsberichts
(PAR)
31-07-2018
Wirkstoff:
eslicarbazepine acetate
Verfügbar ab:
BIAL - Portela & Ca, S.A.
ATC-Code:
N03AF04
INN (Internationale Bezeichnung):
eslicarbazepine acetate
Therapiegruppe:
Antiepileptics,
Therapiebereich:
Epilepsy
Anwendungsgebiete:
Zebinix is indicated as adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.
Produktbesonderheiten:
Revision: 31
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2009-04-21
Gebrauchsinformation
120
B. PACKAGE LEAFLET
121
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZEBINIX 200 MG TABLETS
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 Zebinix is and what it is used for
2.
What you need to know before you take Zebinix
3.
How to take Zebinix
4.
Possible side effects
5.
How to store Zebinix
6.
Contents of the pack and other information
1.
WHAT ZEBINIX IS AND WHAT IT IS USED FOR
Zebinix contains the active substance eslicarbazepine acetate.
Zebinix belongs to a group of medicines called antiepileptics used to
treat epilepsy, a condition where
someone has repeated seizures or fits.
Zebinix 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)
Zebinix has been given to you by your doctor to reduce your number of
seizures.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZEBINIX
DO NOT TAKE ZEBINIX
:
•
if you are allergic to eslicarbazepine acetate, to other carboxamide
derivatives (e.g.
carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or
to any of the other
ingredients of this medicine (listed in section 6);
•
if you suffer from a certain type of heart rhythm disorder (second or
third degree
atriovent
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Fachinformation
1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zebinix 200 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of eslicarbazepine acetate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White oblong tablets, engraved ’ESL 200’ on one side and scored on
the other side, with a length of
11 mm. The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zebinix 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 _
Zebinix 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 mg once daily. Some
patients on monotherapy regimen may benefit from a dose of 1,600 mg
once daily (see section 5.1).
_SPECIAL POPULATIONS _
_Elderly (over 65 years of age) _
No dose adjustment is needed in the elderly population provided that
the renal function is not
disturbed. Due to very limited data on the 1,600 mg monotherapy
regimen in the elderly, this dose is
not recommended for this population.
_Renal impairment _
Caution should be exercised in the treatment of patients, adult and
children above 6 years of age, with
renal impairment and the dose should be adjusted according to
creatinine clearance (CL
CR
) as follows:
-
CL
CR
>60 ml/min: no dose adjustment required.
-
CL
CR
30-60 ml/min: initial dose of 200 mg (or 5 mg/kg in children above 6
years) once daily or
400 mg (or 10 mg/kg in children above 6 years) every other day for 2
weeks followed by a once
daily dose of 400 mg (or 10 mg
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