TRILEPTIN 600 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

OXCARBAZEPINE

Available from:

NOVARTIS ISRAEL LTD

ATC code:

N03AF02

Pharmaceutical form:

FILM COATED TABLETS

Composition:

OXCARBAZEPINE 600 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

NOVARTIS FARMA S.P.A., ITALY

Therapeutic group:

OXCARBAZEPINE

Therapeutic area:

OXCARBAZEPINE

Therapeutic indications:

Treatment of primary generalized tonic-clonic seizures and partial seizures with or without secondary generalization.

Authorization date:

2022-07-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
THE MEDICINE IS DISPENSED WITH
A DOCTOR’S PRESCRIPTION ONLY
TRILEPTIN
®
TRILEPTIN
®
300 MG
600 MG
FILM-COATED TABLETS
FILM-COATED TABLETS
THE ACTIVE INGREDIENT:
Each tablet contains:
Each tablet contains:
Oxcarbazepine 300 mg
Oxcarbazepine 600 mg
Inactive ingredients:
See section 6 ’Further Information‘.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING
THE MEDICINE. This leaflet contains concise information
about the medicine. If you have further questions, refer to
the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it
on to others. It may harm them, even if it seems to you that
their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
For treating epilepsy.
THERAPEUTIC GROUP:
Anti-epileptic.
Epilepsy is a disease characterized by repeated seizures
and convulsions.
Trileptin is intended for the treatment of primary generalized
tonic-clonic seizures and partial seizures, with or without
secondary generalized spread.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
You have a known hypersensitivity )allergy( to oxcarbazepine
)the active ingredient of Trileptin(, eslicarbazepine )an
active ingredient similar to oxcarbazepine( or to any of
the other ingredients contained in the medicine )see section
6 ’Further Information‘(.
If this applies to you, inform the doctor before taking
Trileptin.
If you think that you may be allergic, consult the doctor.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
Refer to your doctor immediately if you experience side
effects that suggest a hypersensitivity reaction. These may
manifest by swelling of the lips, face or neck, accompanied
by difficulty breathing, speaking or swallowing, skin rash,
fever and joint pain.
If you take Trileptin when using oral contraceptives )birth-
control pills(, your periods may become irregular. The pill
may no longer work and you should talk to your doctor
about which other additional c

Summary of Product characteristics

TRI API Aug23 V3
1
Trileptal prescribing information
Approved by SwissMedic on 23/07/23
1.
NAME OF THE MEDICINAL PRODUCT
Trileptin
®
300mg
Trileptin
®
600mg
2.
Composition
_Active substance:_ Oxcarbazepine
_Excipients:_ For the full list of excipients see section 6.1 ‘List
of excipients’.
3.
Pharmaceutical form and quantity of active substance per unit
_Film-coated _
_tablets_
(scored
on
both
sides)
containing
300 mg
or
600 mg
oxcarbazepine.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of primary generalised tonic-clonic seizures and partial
seizures, with or
without secondary generalization.
4.2 Dosage and administration
Trileptin is not approved for use in children less than 2 years of
age.
Dosage
Trileptin is suitable for use either as monotherapy or in combination
with other
antiepileptic drugs. In mono- and adjunctive therapy, treatment with
Trileptin 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
drugs
are
replaced
by
Trileptin,
the
dose
of
the
concomitant antiepileptic drugs(s) should be reduced gradually on
initiation of
Trileptin therapy.
In adjunctive therapy, as the total antiepileptic drug load of the
patient is increased,
the dose of concomitant antiepileptic drug(s) may need to be reduced
and/or the
Trileptin dose increased more slowly (see section 4.5 Interactions).
Therapeutic drug monitoring
The therapeutic effect of oxcarbazepine is primarily exerted through
the active
metabolite 10-monohydroxy derivative (MHD) of oxcarbazepine (section 5
Clinical
pharmacology).
Plasma level monitoring of oxcarbazepine or MHD is not routinely
warranted.
However, plasma level monitoring of MHD may be considered during
Trileptin
therapy in order to rule out noncompliance, or in situations where an
alteration in
MHD clearance is to be expected, including:
•
changes in renal function (see section Dosage in renal impairment)
TRI API Aug23 V3
2
Trileptal prescribing