LECETAM 250MG FILM COATED TABLET

Страна: Малайзія

мова: англійська

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

Активний інгредієнт:

LEVETIRACETAM

Доступна з:

MEDISPEC (M) SDN.BHD

ІПН (Міжнародна Ім'я):

LEVETIRACETAM

Одиниць в упаковці:

3 x 10 Tablets; 6x10 Tablets; 10x10 Tablets

Виробник:

UNISON LABORATORIES CO.LTD

інформаційний буклет

_CONSUMER MEDICATION INFORMATION LEAFLET _
_(RIMUP)_
1
LECETAM FILM COATED TABLET
Levetiracetam (250mg, 500mg)
WHAT IS IN THIS
LEAFLET
1.
What LECETAM is used
for
2.
How LECETAM
works
3.
Before you use
LECETAM
4.
How to use
LECETAM
5.
While you are using
it
6.
Side
effects
7.
Storage and Disposal of
LECETAM
8.
Product
Description
9.
Manufacturer and
Product
Registration
Holder
10. Date of
revision
WHAT LECETAM IS USED
FOR
LECETAM is
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). LECETAM
has
been given to you by your doctor
to
reduce the number of
fits.
• 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 LECETAM
WORKS
LECETAM is an antiepileptic
medicine
(a
medicine used to treat
seizures
in epilepsy).
BEFORE YOU USE
LECETAM
-
_ When you must not use _
_it_
Do not take
LECETAM
• If you are allergic to
levetiracetam,
pyrrolidone derivatives or any of
the
other ingredients of this medicine
(see
section
PRODUCT
DESCRIPTION
).
_Pregnancy and _
_breastfeeding:_
If you are pregnant or breastfeeding,
think
you may be pregnant or are planning
to
have a baby, ask your doctor for
advice
before taking this
medicine.
LECETAM should not be used
during
pregnancy unless clearly necessary

Характеристики продукта

1 of 4
LECETAM 250 MG FILM COATED TABLET
LECETAM 500 MG FILM COATED TABLET
ANTIEPILEPTIC
Each film coated tablet contains:
LEVETIRACETAM 250 MG
LEVETIRACETAM 500 MG

PRODUCT DESCRIPTION:
_250 MG_
:
Light blue, oblong, biconvex, film coated tablet with engraved L-250
on one side and plain on the other
_ _
_500 MG:_
Yellow, oblong, biconvex, film coated tablet with engraved L-500 on
one side and plain on the other

MECHANISM OF ACTION:
Pharmacotherapeutic group: Antiepileptics; Other Antiepileptics
ATC code: N03AX14
_Mechanism of action _
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. The mechanism of action of Levetiracetam still remains to
be fully elucidated.
_In vitro_
and
_in vivo_
experiments suggest that Levetiracetam does not alter basic cell
characteristics and normal neurotransmission.
_In vitro_
studies show that 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 in
_in vitro_
studies
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 protein 2A
seems to contribute to the antiepileptic
mechanism of action of the medicinal product.
Pharmacodynamic effects
Levetiracetam induces seizure protection in a broad range of animal
models of partial and primary generalized