Inovelon 200 mg film-coated tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Rufinamide

Boleh didapati daripada:

EISAI (MALAYSIA) SDN BHD (18039-D)

INN (Nama Antarabangsa):

Rufinamide

Unit dalam pakej:

60tablet Tablets

Dikeluarkan oleh:

Bushu Pharmaceuticals Ltd. Misato factory

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
INOVELON
®
FILM-COATED TABLETS
Rufinamide (200mg)
WHAT IS IN THIS LEAFLET
1.
What INOVELON
®
is used for
2.
How INOVELON
®
works
3.
Before you use INOVELON
®
4.
How to use INOVELON
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
INOVELON
®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT INOVELON
®
IS USED FOR
INOVELON® contains a medicine
called rufinamide. It belongs to a group
of medicines called antiepileptics,
which are used to treat epilepsy (a
condition where someone has seizures
or fits).
INOVELON
®
is used with other
medicines to treat seizures associated
with Lennox-Gastaut syndrome in
adults, adolescents and children over 4
years of age. Lennox-Gastaut syndrome
is the name given to a group of severe
epilepsies in which you may experience
repeated seizures of various types.
INOVELON
®
has been given to you by
your doctor to reduce the number of
your seizures or fits.
HOW INOVELON
®
WORKS
INOVELON
®
acts on the sodium
channels, prolonging their inactive
state.
BEFORE YOU USE INOVELON
®
-
_When you must not use it _
_ _
Do not take INOVELON
®
:
-
if you are allergic to rufinamide or
triazole derivatives or any of the other
ingredients of INOVELON
®.
_Pregnancy and breast-feeding _
If you are a woman of childbearing age,
you must use contraceptive measures
while taking INOVELON
®
.
If you are pregnant, or think you might
be pregnant, or are planning to get
pregnant, ask the doctor or pharmacist
for advice before taking INOVELON
®
.
You must only take INOVELON
®
during your pregnancy if the doctor
tells you to.
You are advised not to breast-feed
while taking INOVELON
®
as it is not
known if rufinamide will be present in
breast milk.
Ask the doctor or pharmacist for advice
before taking any medicine.
_Children _
INOVELON
®
should not be given to
children younger than 4 years of age
since there is not enough information
on its use in this age group.
_INOVELON_
_® _
_co

Ciri produk

PHARMACODE
(3mm FROM EDGE)
TO END AT THIS GUIDE (70mm)
CODE HEIGHT 8mm
LEAD IN / LEAD OUT 10mm
Max Code Length 25mm
PHARMACODE
(3mm FROM EDGE)
TO END AT THIS GUIDE (70mm)
CODE HEIGHT 8mm
LEAD IN / LEAD OUT 10mm
Max Code Length 25mm
Rufinamide
Inovelon®
200 mg
Film-Coated Tablets
Anti-epileptic
1. NAME OF THE MEDICINAL PRODUCT(S)
Rufinamide (Inovelon®) 200 mg film-coated tablets
2. FORMULATION
Each film-coated tablet contains 200 mg of rufinamide.For excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Oral Film-Coated TabletPink, ‘ovaloid’, slightly convex, film-coated tablets, scored on bothsides, embossed ‘Є262’ on one side and blank on the other side.
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
Rufinamide is indicated as adjunctive treatment of seizuresassociated with Lennox-Gastaut syndrome (LGS) in children 4 yearsof age and older and in adults.
4.2 Posology and Method of Administration
Treatment with rufinamide should be initiated by a physicianspecialised in paediatrics or neurology with experience in thetreatment of epilepsy.
PosologyUse in children four years of age or older and less than 30 kg
Patients