Trileptal 60 mg/ml Oral Suspension

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Oxcarbazepine

Dostupné z:

Novartis Ireland Limited

ATC kód:

N03AF; N03AF02

INN (Medzinárodný Name):

Oxcarbazepine

Dávkovanie:

60 milligram(s)/millilitre

Forma lieku:

Oral suspension

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Carboxamide derivatives; oxcarbazepine

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2000-02-18

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
TRILEPTAL® 60 MG/ML ORAL SUSPENSION
oxcarbazepine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
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 only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS 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.
Contents of the pack and other information
1.
WHAT TRILEPTAL IS AND WHAT IT IS USED FOR
WHAT TRILEPTAL IS
Trileptal contains the active substance 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
seizures and 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
disorderly fashion. The result can be
uncoordinated muscular activity that is called an epileptic seizure.
Trileptal is used to treat partial seizures with or without
secondarily generalised tonic-clonic seizures.
_ _
Partial seizures involve a limited area of the brain, but may spread
to the whole brain and may cause a
generalised tonic-clonic seizure. There are two types of partial
seizures: simple and complex. In simple
partial seizures, the patient remains conscious, whereas in complex
p

Súhrn charakteristických

Health Products Regulatory Authority
05 April 2023
CRN00D0H1
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Trileptal 60 mg/ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of the oral suspension contains 60 mg of oxcarbazepine.
Excipient(s) with known effect: Each ml also contains 175 mg sorbitol
(E420), 25 mg propylene glycol (E1520), 0.30 mg
propylparahydroxybenzoate (E216), 1.20 mg methylparahydroxybenzoate
(E218) and 0.8 mg ethanol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension.
Off-white to slightly reddish brown oral suspension.
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).
The prescription for Trileptal oral suspension should be given in
millilitres (see conversion table below which gives the
milligram dose in millilitres). The prescribed dose in millilitres is
rounded to the nearest 0.5 ml.
The doses given in the table below are only applicable to patients
aged 6 years and above. These doses are to be administered
twice a day.
Dose in milligrams (to be given b.i.d)
Dose