Eslicarbazepine acetate Mylan 800 mg Tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Eslicarbazepine acetate

Boleh didapati daripada:

McDermott Laboratories Ltd., T/A Gerard Laboratories

Kod ATC:

N03AF; N03AF04

INN (Nama Antarabangsa):

Eslicarbazepine acetate

Dos:

800 milligram(s)

Borang farmaseutikal:

Tablet

Kawasan terapeutik:

Carboxamide derivatives; eslicarbazepine

Status kebenaran:

Not marketed

Tarikh kebenaran:

2020-03-20

Risalah maklumat

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ESLICARBAZEPINE ACETATE MYLAN 800 MG TABLETS_ _
eslicarbazepine acetate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 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 Eslicarbazepine acetate Mylan is and what it is used for
2.
What you need to know before you take Eslicarbazepine acetate Mylan
3.
How to take Eslicarbazepine acetate Mylan
4.
Possible side effects
5.
How to store Eslicarbazepine acetate Mylan
6.
Contents of the pack and other information
1.
WHAT ESLICARBAZEPINE ACETATE MYLAN IS AND WHAT IT IS USED FOR
Eslicarbazepine acetate Mylan contains the active eslicarbazepine
acetate.
Eslicarbazepine acetate Mylan belongs to a group of medicines called
antiepileptics used to treat epilepsy, a
condition where someone has repeated seizures or fits.
Eslicarbazepine acetate Mylan 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 Mylan has been given to you by your doctor to
reduce your number of seizures.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ESLICARBAZEPINE ACETATE MYLAN
DO NOT TAKE ESLICARBAZEPINE ACETATE MYLAN

if you are allergic to eslicarbazepine acetate, to other carboxamide
derivatives (e.g. carba

Ciri produk

Health Products Regulatory Authority
21 August 2020
CRN009LM3
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eslicarbazepine acetate Mylan 800 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 800 mg of eslicarbazepine acetate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
A white to off-white, capsule shaped, biconvex, bevelled-edge tablet
debossed with 'M' on the left of the score line and 'E' on
the right of the score line on one side of the tablet and '800' on the
other side of the tablet. Approximately 18.95 mm x
9.75 mm in dimension.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Eslicarbazepine acetate Mylan 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_
Eslicarbazepine acetate Mylan may be taken as monotherapy or added to
existing anticonvulsant therapy. The recommended
starting dose is 400 mg once daily (half a tablet) 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 (one and a half tablets). 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 t