LOGUFEN Tablets 250mg

Država: Malezija

Jezik: engleski

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

Aktivni sastojci:

LEVETIRACETAM

Dostupno od:

PAHANG PHARMACY SDN. BHD.

INN (International ime):

LEVETIRACETAM

Jedinice u paketu:

30 Tablets; 100 Tablets

Proizveden od:

KUSUM HEALTHCARE PVT. LTD.

Uputa o lijeku

LOGUFEN
LEVETIRACETAM TABLETS 250 MG & 500 MG
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Logufen is used for
2.
How Logufen works
3.
Before you use Logufen
4.
How to use Logufen
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Logufen
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
1. WHAT LOGUFEN IS USED FOR
Logufen tablets contain a medicine
called Levetiracetam. This belongs to a
group of medicines called Antiepileptic
medicine (a medicine used to treat
seizures in epilepsy).
Logufen is used:

in adults and adolescents from 16
years of age with newly diagnosed
epilepsy, to treat a certain form of
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 seizure with or
without secondary generalisation).
Levetiracetam 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
generalisation in adults and children
from 4 years of age

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 generalised tonic-clonic
seizures (major fits, including loss of
consciousness) in adults and
adolescents from 12 years of age
with idiopathic generalised epilepsy
(the type of epilepsy that is thought
to have a genetic cause).
2. HOW LOGUFEN WORKS
Logufen is an antiepileptic medicine (a
medicine used to treat seizures in
epilepsy).
3. BEFORE YOU USE LOGUFEN
-
_When you must not use it_

If you are allergic (hypersensitive)
to Levetiracetam or other
pyrrolidone derivatives or to any of
the excipients. (These are listed at
the end of the leaflet).

If you hav

Svojstava lijeka

®
LOGUFEN
LEVETIRACETAM TABLETS 250 MG
LEVETIRACETAM TABLETS 500 MG
COMPOSITION:
Each film-coated tablet contains:
Levetiracetam BP………..250 mg/ 500 mg
_EXCIPIENTS:_
®
LOGUFEN TABLETS 250 MG: Maize starch, povidone, croscarmellose sodium,
colloidal anhydrous silica,
magnesium stearate; Opadry (II) 85G68918 white.
®
LOGUFEN TABLETS 500 MG: Maize starch, povidone, croscarmellose sodium,
colloidal anhydrous silica,
magnesium stearate; Opadry (II) 85G52482 yellow.
PRODUCT DESCRIPTION:
®
LOGUFEN TABLETS 250 MG: White to off white color, oval shape, film
coated tablets, with break line on one side.
®
LOGUFEN TABLETS 500 MG: Yellow color, oval shape, film coated
tablets, with break line on one side.
*The break line is non-functional and the scored tablet is not meant
to be cut / split in half.
PHARMACEUTICAL FORM: Film-coated tablet
PHARMACOLOGICAL PROPERTIES:
PHARMACOTHERAPEUTIC GROUP: Antiepileptics. Other antiepileptic.
ATC code: N03AX14
PHARMACODYNAMIC PROPERTIES:
®
Logufen contains Levetiracetam which is a pyrrolidone derivative
(S-enantiomer of α-ethyl-2-oxo-1-
pyrrolidineacetamide), chemically unrelated to existing antiepileptic
active substances.
The mechanism of action of levetiracetam still remains to be fully
elucidated. Levetiracetam does not alter
basic cell characteristics and normal neurotransmission.
2+
2+
Levetiracetam affects intra-neuronal Ca levels by partial inhibition
of N-type Ca currents and by reducing the
2+
release of Ca from intra-neuronal stores. In addition it partially
reverses the reductions in GABA and glycine-
gated currents induced by zinc and β-carbolines. Furthermore,
levetiracetam bind to a specific site. 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 antiseizure
protection. This suggests that the interaction
between levetiracetam an