TRILEPTAL oxcarbazepine 60mg/mL oral suspension bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxcarbazepine, Quantity: 60 mg/mL

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Oral Liquid, suspension

Composition:

Excipient Ingredients: saccharin sodium; propylene glycol; purified water; methyl hydroxybenzoate; sorbitol solution (70 per cent) (non-crystallising); PEG-8 stearate; sorbic acid; propyl hydroxybenzoate; ascorbic acid; dispersible cellulose; Fragrance (perfume)

Administration route:

Oral

Units in package:

1 x 250 mL bottle, 1 x 100 mL bottle, 1 x oral dosing syringe

Prescription type:

(S4) Prescription Only Medicine, Not scheduled. Not considered by committee

Therapeutic indications:

For use as monotherapy or adjunctive therapy for the treatment of partial seizures and generalised tonic-clonic seizures, in adults and children.

Product summary:

Visual Identification: Off-white to slightly reddish-brown suspension; Container Type: Bottle; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2001-12-17

Patient Information leaflet

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.NOVARTIS.COM.AU.
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 the
sufferer may l

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
TRILEPTAL

(OXCARBAZEPINE) FILM-COATED TABLET AND ORAL SUSPENSION
1
NAME OF THE MEDICINE
oxcarbazepine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of Trileptal contains 150 mg, 300 mg or 600 mg
oxcarbazepine. Each mL
of oral suspension contains 60 mg oxcarbazepine.
Excipients with known effect (oral suspension only): hydroxybenzoates,
saccharin, sorbates,
sugar alcohols.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
_Tablets _
Trileptal 150 mg: oval, scored, pale grey green tablets coded TD on
one side and CG on the
other.
Trileptal 300 mg: oval, scored, yellow tablets coded TE/TE on one side
and CG/CG on the other.
Trileptal 600 mg: oval, scored, light pink tablets coded TF/TF on one
side and CG/CG on the
other.
_Oral suspension _
Trileptal 60 mg/mL: off-white to slightly reddish brown oral
suspension supplied with an oral
dosing syringe and a press-in bottle adaptor.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Trileptal is indicated for use as monotherapy or adjunctive therapy
for the treatment of partial
seizures and generalised tonic-clonic seizures, in adults and
children.
4.2
D
OSE AND METHOD OF ADMINISTRATION
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 5.1
Pharmacodynamic properties,
subsection Clinical trials). The dose may be increased depending on
the clinical response of the
patient. When other antiepileptic drugs (AEDs) are replaced by
Trileptal, the dose of the
concomitant AED(s) should be reduced gradually on initiation of
Trileptal therapy. In
adjunctive therapy, as the total antiepileptic drug load of the
patient is increased, the dose of
concomitant AED(s) may need to be reduced and/or the Trileptal dose
increased more slowly.
Trileptal oral suspension and Trileptal film-coated tablet