Levera 250 (Levetiracetam Tablets 250 mg)

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

LEVETIRACETAM

Boleh didapati daripada:

ACCORD HEALTHCARE SDN.BHD.

INN (Nama Antarabangsa):

LEVETIRACETAM

Unit dalam pakej:

10 x 10’s Tablets; 6 x 10’s Tablets

Dikeluarkan oleh:

INTAS PHARMACEUTICALS LIMITED

Risalah maklumat

Consumer Medication Information Leaflet (RiMUP)
LEVERA (LEVETIRACETAM TABLETS)
Levetiracetam (250mg, 500mg, 1000mg)
1
What is in this leaflet
1.
What Levera tablets are used for
2.
How Levera tablets work
3.
Before you use Levera tablets
4.
How to use Levera tablets
5.
While you are using Levera tablets
6.
Side effects
7.
Storage
and
disposal
of
Levera
tablets
8.
Product description
9.
Manufacturer
and
product
registration holder
10.
Date of revision
What Levera tablets are used for
Levera tablets are used on its own in
adults and adolescents from 16 years of
age
with
a
certain
type
of
newly
diagnosed
epilepsy.
Epilepsy
is
a
condition
where
the
patients
have
repeated fits (seizures). Levetiracetam is
used for the epilepsy form in which the
fits initially affect only one side of the
brain,
but
could
thereafter
extend
to
larger areas on both sides of the brain
(partial onset seizures with or without
secondary
generalization).
Levera
tablets have been given to you by your
doctor to reduce the number of fits.
Levera tablets are used as an add-on to
other antiepileptic medicines to treat:

partial onset seizures with or without
secondary
generalization
in
adults
and children from 4 years of age with
epilepsy.

myoclonic
seizures
(short,
shock-
like jerks of a muscle or group of
muscles) in adults and adolescents
from 12 years of age with juvenile
myoclonic epilepsy

primary
generalized
tonic-clonic
seizures (major fits, including loss of
consciousness) in adults and children
from 12 years of age with Idiopathic
Generalized Epilepsy.
How Levera tablets work
Levera tablets belong to a group called
antiepileptic
medicines.
These
medicines help reduce the occurrence of
seizures in epilepsy.
Before you use Levera tablets
-
When you must not take it
Do not take Levera tablets if:
You
are
allergic
(hypersensitive)
to
Levetiracetam
or
any
of
the
other
ingredients of this medicine (see Product
description).
Pregnancy and breastfeeding:
If you are pregnant or breastfeeding,
think
you
may
be
pregnant
or
are
planning to

Ciri produk

FRONT SIDE
BACK SIDE
INP113
RLEV03I2044
PACKAGE INSERT
LEVERA 250, 500 & 1000
(LEVETIRACETAM TABLETS
250 MG, 500 MG &
1000 MG)
NAME AND STRENGTH OF ACTIVE INGREDIENT
LEVERA 250
Levetiracetam Ph. Eur. 250 mg
LEVERA 500
Levetiracetam Ph. Eur. 500 mg
LEVERA 1000
Levetiracetam Ph. Eur. 1000 mg
PRODUCT DESCRIPTION
LEVERA 250
White to off white, oval, biconvex, film coated tablets debossed ‘L
64’
and breakline on one side and plain on other side.
LEVERA 500
Yellow coloured, oval, biconvex, film coated tablets debossed ‘L
65’
and breakline on one side and plain on other side.
LEVERA 1000
White to off white, oval, biconvex, film coated tablets debossed ‘L
67’
and breakline on one side and plain on other side.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC
code: N03AX14.
The active substance, Levetiracetam, is a pyrrolidone derivative
(S-enantiomer of α-ethyl-2-oxo-1-pyrrolidine acetamide), chemically
unrelated to existing antiepileptic active substances.
Mechanism of action
The mechanism of action of Levetiracetam still remains to be fully
elucidated. Levetiracetam does not alter basic cell characteristics
and
normal neurotransmission.
Levetiracetam affects intraneuronal Ca
2+
levels by partial inhibition of
N-type Ca
2+
currents and by reducing the release of Ca
2+
from
intraneuronal stores. In addition it partially reverses the reductions
in
GABA- and glycine-gated currents induced by zinc and β-carbolines.
Furthermore, Levetiracetam has been shown to bind to a specific site
in rodent brain tissue. This binding site is the synaptic vesicle
protein
2A, believed to be involved in vesicle fusion and neurotransmitter
exocytosis. Levetiracetam and related analogs show a rank order of
affinity for binding to the synaptic vesicle protein 2A which
correlates
with the potency of their anti-seizure protection in the mouse
audiogenic model of epilepsy. This finding suggests that the
interaction between Levetiracetam and the synaptic vesicle