Exalief
Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Листовка
(PIL)
16-08-2012
Данни за продукта
(SPC)
16-08-2012
Доклад обществена оценка
(PAR)
16-08-2012
Активна съставка:
eslicarbazepine acetate
Предлага се от:
BIAL - Portela Ca, S.A.
АТС код:
N03AF04
INN (Международно Name):
eslicarbazepine acetate
Терапевтична група:
Antiepileptics,
Терапевтична област:
Epilepsy
Терапевтични показания:
Exalief is indicated as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.
Каталог на резюме:
Revision: 5
Статус Оторизация:
Withdrawn
Дата Оторизация:
2009-04-21
Листовка
52
B. PACKAGE LEAFLET
Medicinal product no longer authorised
53
PACKAGE LEAFLET: INFORMATION FOR THE USER
EXALIEF 400 MG TABLETS
Eslicarbazepine acetate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What Exalief is and what it is used for
2.
Before you take Exalief
3.
How to take Exalief
4.
Possible side effects
5.
How to store Exalief
6.
Further information
1.
WHAT EXALIEF IS AND WHAT IT IS USED FOR
Exalief belongs to a group of medicines called anti-epileptics used to
treat epilepsy, a condition where
someone has repeated seizures or fits.
Exalief is used in adult patients who are already taking other
anti-epileptic medicines and are still
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).
Exalief has been given to you by your doctor to reduce your number of
seizures.
2.
BEFORE YOU TAKE EXALIEF
DO NOT TAKE EXALIEF IF
:
•
you are allergic (hypersensitive) to the active substance
(eslicarbazepine acetate), to other
carboxamide derivatives (e.g. carbamazepine or oxcarbazepine,
medicines used to treat epilepsy) or to
any of the other ingredients
•
you suffer from a certain type of heart rhythm disorder (second or
third degree atrioventricular (AV)
block)
TAKE SPECIAL CARE WITH EXALIEF
Contact your doctor immediately if:
•
you have rash, swallowing or breathing problems, swelling of your
lips, face, throat or tongue. These
could be signs of an allergic reaction.
•
you suffer from confusion, worsening of seizures or decreased
conscious
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Данни за продукта
1
_ _
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Exalief 400 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400 mg of eslicarbazepine acetate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White circular biconvex tablets, engraved ‘ESL 400’on one side and
scored on the other side. The scoreline
is only to facilitate breaking for ease of swallowing and not to
divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Exalief is indicated as adjunctive therapy in adults with
partial-onset seizures with or without secondary
generalisation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Exalief must be 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 1200 mg once daily (see section 5.1).
_Elderly (over 65 years of age) _
Caution should be exercised in the treatment of elderly patients as
there is limited safety information on the
use of Exalief in these patients.
_Paediatric population _
The safety and efficacy of Exalief in children below 18 years has not
yet been established. No data are
available.
_Patients with renal impairment _
Caution should be exercised in the treatment of patients 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 400 mg every other day for 2 weeks
followed by a once daily dose of
400 mg. However, based on individual response, the dose may be
increased.
-
CL
CR
<30 ml/min: use is not recommended in patients with severe renal
impairment due to insufficient
data
_ _
_Patients with hepatic impairment _
No dose adjustment is needed in patients with mild to moderate hepatic
impairment.
The pharmacokinetics of eslicarbazep
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