TRILEPTAL 600 MG FILM-COATED TABLET

Država: Malezija

Jezik: engleski

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

Aktivni sastojci:

OXCARBAZEPINE

Dostupno od:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International ime):

OXCARBAZEPINE

Jedinice u paketu:

50Tablet Tablets

Proizveden od:

NOVARTIS FARMA S.P.A.

Uputa o lijeku

_Consumer Medication Information Leaflet (RiMUP) _
TRILEPTAL
®
TABLET
_ _
Oxcarbazepine (300mg, 600mg)
1
WHAT IS IN THIS LEAFLET
1.
WHAT TRILEPTAL IS USED FOR
2.
HOW TRILEPTAL WORKS
3.
BEFORE YOU USE TRILEPTAL
4.
HOW TO USE TRILEPTAL
5.
WHILE USING TRILEPTAL
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF
TRILEPTAL
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
11.
SERIAL NUMBER
WHAT TRILEPTAL IS USED FOR
Trileptal belongs to group of
medicines called anticonvulsants or
antiepileptics (medicines to treat
epilepsy).
Trileptal is used to treat partial
seizure (involves a limited area of
the brain) and generalised tonic-
clonic seizures (involves a wide area
of the brain, cause loss of
consciousness and can affect the
whole body), in adults and children.
Trileptal can be used alone (i.e.
monotherapy) or in combination
with other antiepileptic medicines.
It can replace other antiepileptic
medicines when current therapy
provides insufficient seizure control.
HOW TRILEPTAL WORKS
Trileptal works by keeping the
brain’s “overexcitable” nerve cells
under control, thereby suppressing
or reducing the frequency of such
seizures.
BEFORE YOU USE TRILEPTAL
Follow all the doctor’s instructions
carefully. They may differ from the
general information contained in
this leaflet.
The risk of serious skin reactions in
patients of Han Chinese or Thai
origin associated with
oxcarbazepine, carbamazepine or
chemically-related compounds may
be predicted by testing a blood
sample of these patients.
_ _
_MONITORING DURING YOUR TREATMENT _
_WITH TRILEPTAL _
Before and during your treatment
with Trileptal, your doctor may
perform blood tests to determine the
dose for you. Your doctor will tell
you when to have the tests.
_When you must not use Trileptal _

If you are allergic
(hypersensitive) to
oxcarbazepine (the active
substance of Trileptal) or
eslicarbazepine (another active
substance related to
oxcarbazepine) or any of the
other ingredients of Trileptal
listed at the end of this leaflet.

Svojstava lijeka

Novartis
Page 2
Malaysian Package Leaflet
17-Jul-2017
Trileptal FCT
TRILEPTAL

FILM-COATED TABLETS
Antiepileptic.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
300 mg: yellow, ovaloid slightly biconvex tablets, scored on both
sides. Embossed with
TE/TE on one side and CG/CG on the other side.
_ _
600 mg: light pink, ovaloid slightly biconvex tablets scored on both
sides. Embossed with
TF/TF on one side and CG/CG on the other side.
ACTIVE SUBSTANCE
Each Trileptal film-coated tablet contains 300 mg or 600 mg
oxcarbazepine.
Appearance of tablets may differ between countries. Certain dosage
strengths may not be
available in all countries.
ACTIVE MOIETY
Oxcarbazepine
EXCIPIENTS
Tablet
core:
silica,
colloidal
anhydrous;
cellulose,
microcrystalline;
hypromellose;
crospovidone; magnesium stearate;
Tablet coating: hypromellose; talc; titanium dioxide (E171);.
_300 mg tablet coating only:_
macrogol 8000; iron oxide, yellow (E 172).
_600 mg tablet coating only: _
macrogol 4000; iron oxide red (E 172); iron oxide black (E 172).
Pharmaceutical formulations may vary between countries.
INDICATIONS
Trileptal is indicated for the treatment of partial seizures (which
include the seizure subtypes
of simple, complex and partial seizures evolving to secondarily
generalized seizures) and
generalized tonic-clonic seizures, in adults and in children.
Trileptal is indicated as a first-line antiepileptic medicinal product
for use as monotherapy or
adjunctive therapy.
Trileptal can replace other antiepileptic medicinal products when
current therapy provides
insufficient seizure control (see section PHARMACODYNAMICS - Clinical
studies).
Novartis
Page 3
Malaysian Package Leaflet
17-Jul-2017
Trileptal FCT
DOSAGE AND ADMINISTRATION
DOSAGE
Trileptal is suitable for use either as monotherapy or in combination
with other antiepileptic
drugs. In mono- and adjunctive therapy, treatment with Trileptal is
initiated with a clinically
effective dose given in two divided doses (see section CLINICAL
STUDIES). The dose may
be increased depending on t