TRILEPTAL 600 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OXCARBAZEPINE

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

N03AF02

INN (International Name):

OXCARBAZEPINE

Dosage:

600 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Antiepileptics

Authorization status:

Authorised

Authorization date:

2000-02-18

Patient Information leaflet

Live Text:

Yes /
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No /
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Production Site:
Torre
WO:
1315448
CTM:
Monsurro’, Rosanna
Comp. Description:
LEAFLET_TRILEPTAL FCT ALL
DOSAGES_IE
Printing Colours:
Black
Comp. No. New:
1221613 IE TA
Comp. No. Old:
1218220-1228221 IE TA
Format/Dimension:
148 x 314.96 mm
Tech. Drawing No.:
5666/O
Technical Colours:
Cutting
Min. Font Size Text:
7.2 pt
Font Type:
News Gothic
Version No.:
2
Date: 11 Nov 2014
J.N.: 239683
Braille:
N/A
! PLEASE TURN OVERPRINTING ON !
1221613 IE TA
PACKAGE LEAFLET:
INFORMATION FOR THE USER
TRILEPTAL 150 MG
FILM-COATED TABLETS
TRILEPTAL 300 MG
FILM-COATED TABLETS
TRILEPTAL 600 MG
FILM-COATED TABLETS
Oxcarbazepine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or
pharmacist.
– This medicine has been prescribed for you or your
child. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
– If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet (see
section 4), please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Trileptal is and what it is used for
2. What you need to know before you take Trileptal
3. How to take Trileptal
4. Possible side effects
5. How to store Trileptal
6. Further information
1.
WHAT TRILEPTAL IS AND WHAT IT IS USED FOR
WHAT TRILEPTAL IS
The active ingredient of Trileptal is oxcarbazepine.
Trileptal belongs to a group of medicines called
anticonvulsants or antiepileptics.
WHAT TRILEPTAL IS USED FOR
Medicines such as Trileptal are the standard treatment
for epilepsy.
Epilepsy is a brain disorder that causes people to
have recurring seizuresand convulsions. Seizures
happen because of a temporary fault in the brain’s
electrical activity. Normally brain cells coordinate body
movements by sending out signals through the nerves
to the muscles in an organised, orderly way. In epilepsy,
brain cells send out too many signals in a disord

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Trileptal 600 mg Film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg oxcarbazepine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
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 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 for the treatment of partial seizures with or
without secondarily generalised tonic-clonic seizures.
Trileptal is indicated for use as monotherapy or adjunctive therapy in
adults and in children of 6 years of age and
above.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
In mono- and adjunctive therapy, treatment with Trileptal is initiated
with a clinically effective dose given in two
divided doses. The dose may be increased depending on the clinical
response of the patient. When other antiepileptic
medicinal products 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 medicinal product
load of the patient is increased, the dose of concomitant
antiepileptic medicinal product(s) may need to be reduced
and/or the Trileptal dose increased more slowly (see section 4.5).
THERAPEUTIC DRUG MONITORING
The therapeutic effect of oxcarbazepine is primarily exerted through
the active metabolite 10-monohydroxy derivative
(MHD) of oxcarbazepine (see section 5).
Plasma level monitoring of oxcarbazepine or MHD is not routinely
warranted. However, may be useful in situations
where an alteration in MHD clearance is to be expected (see section
4.4). In such situations, the dose of Trileptal may
be adjusted (based on plasma levels measured 2-4 hours post dose) to
maintain peak MHD plasma l