LEVAUR 500 (Levetiracetam Tablets 500 mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LEVETIRACETAM

Boleh didapati daripada:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

LEVETIRACETAM

Unit dalam pakej:

3x10tablet Tablets

Dikeluarkan oleh:

Aurobindo Pharma Limited (Unit III),

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
LEVAUR 250 (LEVETIRACETAM TABLETS 250MG)
LEVAUR 500 (LEVETIRACETAM TABLETS 500MG)
Levetiracetam (250mg, 500mg)
1
WHAT IS IN THIS LEAFLET
1.
What LEVAUR is used for
2.
How LEVAUR works
3.
Before you use LEVAUR
4.
How to use LEVAUR
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
LEVAUR
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT IS LEVAUR USED FOR
LEVAUR is used to control epilepsy.
Epilepsy is a condition where you
have repeated seizures (fits). There
are many different kinds of seizures
that can be mild or severe in nature.
LEVAUR can be used alone or in
combination with other medicines to
treat your condition.
LEVAUR is used in patients who are
already taking other anti-epileptic
medicines:
•
For treating partial seizures
in adults and children from
4 years of age.
•
For treating myoclonic
seizures in adults and
adolescents from 12 years
of age with Juvenile
Myoclonic Epilepsy.
•
For treating primary
generalized tonic-clonic
seizures in adults and
adolescents from 12 years
of age with Idiopathic
Generalized Epilepsy.
HOW LEVAUR WORKS
LEVAUR contains the active
ingredient levetiracetam, which
belongs to a group of medicines
called anti-epileptics. It is thought to
control brain chemicals which send
signals to nerves, so that seizures do
not occur.
BEFORE YOU USE LEVAUR
_-When you must not use it _
Do not use LEVAUR if you are
allergic to:
•
Any medicine containing
levetiracetam.
•
Medicines derived from a
chemical called pyrrolidine
(e.g. piracetam) or any of
the ingredients that are
listed here.
If you are unsure about the use of
LEVAUR, please consult your
doctor or pharmacist for further
advice.
_-Before you start to use it _
Inform your doctor if you have any
known allergies.
It is important to inform your doctor
if:
•
You suffer from any kidney
or liver related health issues.
Your doctor will adjust the
dose of this medication for
you accordingly.
•
You have any blood rel

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SUMMARY OF PRODUCT CHARACTERISTICS
LEVAUR
LEVETIRACETAM TABLETS 250 MG, 500 MG
NAME OF THE MEDICINAL PRODUCT :
Levetiracetam Tablets 250 mg.
Levetiracetam Tablets 500 mg.
(TRADE) NAME OF PRODUCT
:
LEVAUR 250.
LEVAUR 500.
STRENGTH
:
250 mg, 500 mg.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levetiracetam Tablets 250 mg: Each film-coated tablet contains 250 mg
Levetiracetam.
Levetiracetam Tablets 500 mg: Each film-coated tablet contains 500 mg
Levetiracetam.
PHARMACEUTICAL FORM
_Levetiracetam Tablets 250 mg: _Blue oval shaped biconvex film -coated
tablets debossed with a deep break line separating
‘E’ and ‘10’ on one side and plain on the other side.
_Levetiracetam Tablets 500mg: _Yellow oval shaped biconvex film
-coated tablets debossed with a deep break line separating
‘E’ and ‘11’ on one side and plain on the other side.
CLINICAL PARTICULARS
Therapeutic indications
Levetiracetam is indicated as monotherapy in the treatment of partial
onset seizures with or without secondary
generalisation in patients 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 and children from 4 years
of age with epilepsy.
•
in the treatment of myoclonic seizures in adults and adolescents from
12 years of age with Juvenile Myoclonic
Epilepsy.
•
in the treatment of primary generalised tonic-clonic seizures in
adults and adolescents from 12 years of age with
Idiopathic Generalised Epilepsy.
POSOLOGY AND METHOD OF ADMINISTRATION
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.
Adults
•
Monotherapy
Adults and adolescents from 16 years of age
The recommended starting dose is 250 mg tw