ZEBINIX 800 MG

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

ESLICARBAZEPINE ACETATE

Beschikbaar vanaf:

TRUEMED LTD, ISRAEL

ATC-code:

N03AF04

farmaceutische vorm:

TABLETS

Samenstelling:

ESLICARBAZEPINE ACETATE 800 MG

Toedieningsweg:

PER OS

Prescription-type:

Required

Geproduceerd door:

BIAL - PORTELA & Cª, S.A, PORTUGAL

Therapeutisch gebied:

ESLICARBAZEPINE

therapeutische indicaties:

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.

Autorisatie datum:

2022-10-23

Bijsluiter

Page 1 of 7
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
ZEBINIX 200 MG
ZEBINIX 800 MG
TABLETS
ACTIVE INGREDIENT:
EACH ZEBINIX 200 MG TABLET CONTAINS 200 MG ESLICARBAZEPINE ACETATE.
EACH ZEBINIX 800 MG TABLET CONTAINS 800 MG ESLICARBAZEPINE ACETATE.
For inactive ingredients and allergens in the medicine, see section 6
'Additional information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains concise
information about this medicine. If you have any further questions,
consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them,
even if it seems to you that their illness is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Zebinix is used:

as a single medicine (monotherapy) for treatment of partial seizures
with or without secondary
generalisation in adult patients with newly diagnosed epilepsy.

with other antiepileptic medicines (adjunctive therapy), for treatment
of adult, adolescent and
pediatric patients above 6 years of age experiencing partial seizures
with or without secondary
generalisation.
THERAPEUTIC GROUP: antiepileptic medicines, carboxamide derivatives.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:

You are sensitive (allergic) to the active ingredient eslicarbazepine
acetate, to other
carboxamide derivatives (e.g. carbamazepine or oxcarbazepine,
medicines used to treat
epilepsy) or to any of the other ingredients in this medicine (see
section 6 'Additional
information').

You
suffer
from
a
certain
type
of
heart
rhythm
disorder
(second
or
third
degree
atrioventricular (AV) block).
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
CONTACT YOUR DOCTOR IMMEDIATELY:

If you have blistering or peeling of the skin and/or mucous membranes,
rash, swallowing or
breathing problems, swelling of your lips, face, eyelids, throat or
tongue. These could be signs
of

Productkenmerken

1
1.
NAME OF THE MEDICINAL PRODUCT
Zebinix® 200 mg
Zebinix® 800 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zebinix 200mg
Each tablet contains 200 mg of eslicarbazepine acetate.
Zebinix 800mg
Each tablet contains 800 mg of eslicarbazepine acetate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Zebinix 200mg
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.
_ _
Zebinix 800mg
White oblong tablets, engraved ‘ESL 800’on one side and scored on
the other side, with a length of 19
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).
_ _
_ _
_ _
_ _
_ _
2
_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/mi