INTIRACETAM 500 mg Film-coated Tablets

Land: Maleisië

Taal: Engels

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

Werkstoffen:

LEVETIRACETAM

Beschikbaar vanaf:

Intega Sdn. Bhd.

INN (Algemene Internationale Benaming):

LEVETIRACETAM

Eenheden in pakket:

60 Tablets

Geproduceerd door:

Rontis Hellas Medical and Pharmaceutical Products S.A.

Bijsluiter

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
INTIRACETAM FILM COATED TABLET
Levetiracetam (250mg, 500mg, 1000mg)
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
11.
Serial Number
WHAT INTIRACETAM IS USED FOR
INTIRACETAM 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).
INTIRACETAM 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 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 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.

Productkenmerken

INTIRACETAM
Levetiracetam
_
_-
INTIRACETAM 250 mg Film-coated Tablets
INTIRACETAM 500 mg Film-coated Tablets
INTIRACETAM 1000 mg Film-coated Tablets
PHARMACEUTICAL FORM AND STRENGTH
_Levetiracetam, 250 mg, film-coated tablets _
Each film-coated tablet contains 250 mg of levetiracetam..
Blue color, oval shaped film coated tablets with a break line on one
side.
_Levetiracetam, 500 mg, film-coated tablets _
Each film-coated tablet contains 500 mg of levetiracetam.
Yellow color, oval shaped film coated tablets with a break line on one
side.
_Levetiracetam, 1000 mg, film-coated tablets _
Each film-coated tablet contains 1000 mg of levetiracetam .
White color, oval shaped film coated tablets with a break line on one
side.
EXCIPIENTS
_Levetiracetam, 250 mg, film-coated tablets _
Crospovidone (type B) (E1202), Povidone K30, Silica, colloidal
anhydrous (E551),
Magnesium stearate (E470b), Hypromellose (E464), Macrogol / PEG 400
(E1521),
Titanium dioxide (E171), Talc (E553b), Indigo carmine aluminium lake
(E132), Water,
purified
_Levetiracetam, 500 mg, film-coated tablets _
Crospovidone (type B) (E1202), Povidone K30, Silica, colloidal
anhydrous (E551),
Magnesium stearate (E470b), Hypromellose (E464), Macrogol / PEG 400
(E1521),
Titanium dioxide (E171), Talc (E553b), Iron oxide yellow (E172),
Water, purified
_Levetiracetam, 1000 mg, film-coated tablets _
Crospovidone (type B) (E1202), Povidone K30, Silica, colloidal
anhydrous (E551),
Magnesium stearate (E470b), Hypromellose (E464), Macrogol / PEG 400
(E1521),
Titanium dioxide (E171), Talc (E553b), Water, purified
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