INTIRACETAM Levetiracetam 100mgml Oral Solution

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LEVETIRACETAM

Boleh didapati daripada:

Intega Sdn. Bhd.

INN (Nama Antarabangsa):

LEVETIRACETAM

Unit dalam pakej:

300 ml

Dikeluarkan oleh:

Remedica Ltd.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
INTIRACETAM ORAL SOLUTION
Levetiracetam 100mg/ml
1
WHAT IS IN THIS LEAFLET
1.
What INTIRACETAM is
used for
2.
How INTIRACETAM
works
3.
Before you use
INTIRACETAM
4.
How to use
INTIRACETAM
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
INTIRACETAM
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT INTIRACETAM IS USED
FOR
INTIRACETAM is used:
•
on its own in patients from 16
years of age with newly
diagnosed epilepsy, to treat
partial onset seizures with or
without secondary
generalization.
•
as an add-on to other
antiepileptic medicines to
treat:
-partial onset seizures with or
without secondary
generalisation 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 generalised tonic-
clonic seizures (major fits,
including loss of
consciousness) in adults and
children from 12 years of age
with idiopathic generalised
epilepsy
HOW INTIRACETAM WORKS
INTIRACETAM is an
antiepileptic medicine (a
medicine used to treat seizures
in epilepsy).
BEFORE YOU USE INTIRACETAM
_-When you must not use it _
Do not take INTIRACETAM
•
If you are allergic
(hypersensitive) to
levetiracetam or any of the
other ingredients of this
medicine (listed in Product
Description).
_Pregnancy and breast-feeding _
Ask your doctor or pharmacist
for advice before taking any
medicine.
If you are pregnant or if you
think you may be pregnant,
please inform your doctor.
INTIRACETAM should not be
used during pregnancy unless
clearly necessary. The potential
risk to your unborn child is
unknown.
Breast-feeding is not
recommended during treatment.
_Children and adolescent _
INTIRACETAM is not
indicated in children and
adolescent below 16 years on its
own (monotherapy)
_-Before you start to use it _
Talk to your doctor before
taking INTIRACETAM
•
If you suffer from kidn

Ciri produk

INTIRACETAM
Levetiracetam
NAME OF THE MEDICINAL PRODUCT
INTIRACETAM Levetiracetam 100 mg/ml Oral Solution
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Levetiracetam, 100 mg/ml, oral solution _
Each ml contains 100 mg of levetiracetam.
EXCIPIENTS
Sodium citrate, Citric acid, Methyl parahydroxybenzoate, Glycerol,
Acesulfame potassium, Liquid Maltitol, Raspberry liquid, Purified
water.
PHARMACEUTICAL FORM
Levetiracetam, 100 mg/ml, oral solution
Clear, colourless liquid with sweet fruity odour and bitter raspberry
flavor
CLINICAL INFORMATION
INDICATIONS
INTIRACETAM 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.
INTIRACETAM 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 children from 12 years of age with Idiopathic Generalised
Epilepsy.
ROUTE OF ADMINISTRATION
For oral use.
DOSAGE AND ADMINISTRATION
Oral solution
The oral solution may be diluted in a glass of water and may be taken
with or without food. After oral administration the bitter taste of
levetiracetam may be
experienced. 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 twice daily which should be
increased to an initial therapeutic dose of 500 mg twice daily after
two weeks. The dose can
be
further
increased
by
250
mg
twice
daily
every
two
weeks
depending
upon
the
clinical
response.
The
maximum
dose
is
1500
mg
twice
daily.
_ADD-ON THERAPY _
Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg
or more
The initial therapeutic dose is 500 mg twice daily. This dose can be
s