Levet® 250mg Film-Coated Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LEVETIRACETAM

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

LEVETIRACETAM

Unit dalam pakej:

100tablet Tablets; 60tablet Tablets; 30tablet Tablets

Dikeluarkan oleh:

LEK PHARMACEUTICALS D.D.

Risalah maklumat

LEVET
® 250MG & 500MG FILM-COATED TABLET
Levetiracetam 250mg & 500mg
1
_Consumer Medication Information Leaflet (RiMUP) _
WHAT IS IN THIS LEAFLET:
1.
What LEVET is used for
2.
How LEVET works
3.
Before you use LEVET
4.
How to use LEVET
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of LEVET
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT LEVET IS USED FOR
LEVET 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).
Levet 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 LEVET WORKS
Levet is an antiepileptic medicine (a
medicine used to treat seizures in
epilepsy).
BEFORE YOU USE LEVET
-
_When you must not use it _
Do not take Levet
•
If you are allergic to levetiracetam,
pyrrolidone derivatives or any of the
other ingredients of this medicine
(see section PRODUCT DESCRIPTION
).
_ _
_Pregnancy and _
_breast-feeding_
_ _
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.
Levet should not be used during
pregnancy unless clearly necessary. A ris

Ciri produk

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PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Levet
®
250 mg Film-Coated Tablet
Levet
®
500 mg Film-Coated Tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levet
®
250 mg Film-Coated Tablet:
Each film-coated tablet contains 250 mg levetiracetam.
Levet
®
500 mg Film-Coated Tablet:
Each film-coated tablet contains 500 mg levetiracetam.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Levet
®
250 mg Film-Coated Tablet:
Light blue, oval, biconvex film-coated tablets, scored on both sides,
debossed with LVT / 250 on one side.
Levet
®
500 mg Film-Coated Tablet:
Yellow, oval, biconvex film-coated tablets, scored on both sides,
debossed with LVT / 500 on one side.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levetiracetam is indicated as monotherapy in the treatment of partial
onset seizures with or without secondary
generalisation in adults and adolescents from 16 years of age with
newly diagnosed epilepsy.
Levetiracetam is indicated as adjunctive therapy in the treatment of:
−
partial onset seizures with or without secondary generalisation in
adults, adolescents and children from 4
years of age with epilepsy.
−
myoclonic seizures in adults and adolescents from 12 years of age with
Juvenile Myoclonic Epilepsy.
−
primary generalised tonic-clonic seizures in adults and adolescents
from 12 years of age with Idiopathic
Generalised Epilepsy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE AND ADMINISTRATION
Levetiracetam therapy can be initiated with either intravenous or oral
administration. Conversion to or from
oral to intravenous administration can be done directly without
titration. The total daily dose and frequency of
administration should be maintained.
_Film-coated tablets _
The film-coated tablets must be taken orally, swallowed with a
sufficient quantity of liquid and may be taken
with or without food. The daily dose is administered in two equally
divided doses.
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ROUTE OF ADMINI