Trileptal 60mg/ml oral suspension

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Oxcarbazepine

Verfügbar ab:

Novartis Pharmaceuticals UK Ltd

ATC-Code:

N03AF02

INN (Internationale Bezeichnung):

Oxcarbazepine

Dosierung:

60mg/1ml

Darreichungsform:

Oral suspension

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 04080100; GTIN: 5010678920048

Gebrauchsinformation

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
partial seizure

Fachinformation

OBJECT 1
TRILEPTAL 60 MG/ML ORAL SUSPENSION
Summary of Product Characteristics Updated 25-May-2018 | Novartis
Pharmaceuticals UK Ltd
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.
Excipients: Each ml also contains 0.30 mg propylparahydroxybenzoate
(E216), 1.20 mg
methylparahydroxybenzoate (E218), 250 mg sorbitol 70 % liquid (non
crystallising) and 0.9 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)