Trileptal

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Oxcarbazepine 300mg;  ;  

Available from:

Novartis New Zealand Ltd

INN (International Name):

Oxcarbazepine 300 mg

Dosage:

300 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Oxcarbazepine 300mg     Excipient: Colloidal silicon dioxide Crospovidone Hypromellose   Iron oxide yellow Macrogol 8000 Magnesium stearate Powdered cellulose Purified talc Titanium dioxide

Units in package:

Blister pack, PVC/PE/PVDC-Al, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Novartis Grimsby Limited

Therapeutic indications:

Trileptal is indicated in adults and children aged 1 month and above for the treatment of · Partial seizures (which include the seizure subtypes of simple, complex and partial seizures evolving to secondarily generalised seizures) and · Generalised tonic-clonic seizures. Trileptal is indicated as a first-line antiepileptic drug for use as monotherapy or adjunctive therapy. Trileptal can replace other antiepileptic drugs when current therapy provides insufficient seizure control.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC-Al - 100 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1998-12-23

Patient Information leaflet

TRILEPTAL
®
1
TRILEPTAL
®
_oxcarbazepine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Trileptal.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.MEDSAFE.GOVT.NZ.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you or your child taking
this medicine against the benefits
they expect it will have.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TRILEPTAL IS USED
FOR
Trileptal belongs to a group of
medicines called anticonvulsants or
antiepileptics. Trileptal is used in
adults and children to control some
types of epilepsy.
Epilepsy is a condition in which there
are repeated convulsions or seizures
(fits). Seizures happen because of a
temporary fault in the brain's
electrical system.
Normally, brain cells coordinate
body movements by sending out
signals through the nerves to the
muscles in an orderly way.
In epilepsy, brain cells send out too
many signals in a disorderly fashion.
The result can be uncoordinated
muscular activity that is called an
epileptic seizure.
Trileptal works by keeping the
brain's overexcitable nerve cells
under control, thereby, reducing the
frequency of seizures.
There are two main classes of
seizures: generalised and partial.
GENERALISED SEIZURES -
involve a wide area of the brain, and
can affect the whole body.
•
Tonic-clonic (or grand mal)
seizures are a sub-type of
generalised seizure in which th

Summary of Product characteristics

NEW ZEALAND DATA SHEET
1.
NAME OF THE MEDICINAL PRODUCT
TRILEPTAL

Film coated tablets
Oxcarbazepine 150 mg and 600 mg, Film-Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg or 600 mg oxcarbazepine.
For a full list of excipients, see Pharmaceutical Particulars, LIST OF
EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Film-coated tablets
150 mg: pale grey green, ovaloid slightly biconvex tablets, scored on
both sides. Embossed with T/D
on one side and C/G 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.
The score line on two sides of Trileptal 150 mg or 600 mg film-coated
tablet is only to facilitate breaking
for ease of swallowing and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Trileptal
®
is indicated in adults and in children aged 1 month and above for the
treatment of:
•
Partial seizures (which include the seizure subtypes of simple,
complex and partial seizures
evolving to secondarily generalised seizures) and
•
Generalised tonic-clonic seizures.
Trileptal is indicated as a first-line antiepileptic drug for use as
monotherapy or adjunctive therapy.
Trileptal can replace other antiepileptic drugs when current therapy
provides insufficient seizure
control (see CLINICAL STUDIES).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
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 CLINICAL STUDIES). The dose may be increased
depending on the clinical
response of the patient. When other antiepileptic drugs are replaced
by Trileptal, the dose of the
concomitant antiepileptic medicinal product(s) should be reduced
gradually on initiation of Trileptal
therapy. In adjunctive therapy, as the total antiepileptic drug load
of the patient is increased