Trileptal 60 mg/ml Oral Suspension

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Oxcarbazepine

Disponible depuis:

Lexon Pharmaceuticals (Ireland) Limited

Code ATC:

N03AF02

DCI (Dénomination commune internationale):

Oxcarbazepine

Dosage:

60 milligram(s)/millilitre

forme pharmaceutique:

Oral suspension

Domaine thérapeutique:

oxcarbazepine

Date de l'autorisation:

2018-04-27

Notice patient

TRILEPTAL 60 MG/ML ORAL SUSPENSION
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFOMATION 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:
What Trileptal is and what it is used for
What you need to know before you take Trileptal
How to take Trileptal
Possible side effects
How to store Trileptal
Contents of the pack and other information
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 seizures, patients consciousness is

Résumé des caractéristiques du produit

Health Products Regulatory Authority
24 November 2022
CRN00D819
Page 1 of 2
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 oxcarbazepine.
Excipient(s) with known effect: propyl parahydroxybenzoate (E216),
methyl parahydroxybenzoate (E218), sorbitol liquid
(non-crystallising) and ethanol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension.
_Product imported from Greece_
Off-white to slightly reddish brown oral suspension.
4 CLINICAL PARTICULARS
As per PA0896/033/004
5 PHARMACOLOGICAL PROPERTIES
As per PA0896/033/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Propyl parahydroxybenzoate (E216)
Saccharin sodium
Sorbic acid (E200)
Macrogol stearate 400
Methyl parahydroxybenzoate (E218)
Yellow-plum-lemon flavour (containing ethanol)
Ascorbic acid (E300)
Dispersible cellulose (containing microcrystalline cellulose and
carmellose sodium)
Propylene glycol
Sorbitol 70% liquid (non-crystallising)
Purified water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the bottle and outer package of the product on the
market in the country of origin.
Use within 7 weeks after first opening the bottle.
Health Products Regulatory Authority
24 November 2022
CRN00D819
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Brown (amber) glass bottles containing 250 ml of oral suspension. The
bottles have a child-resistant cap and are packed in a
cardboard box together with a 10 ml oral syringe and press-in bottle
adapter.
Pack size: 1 bottle
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon Pharmaceuticals (Ireland) Limited
Block 3
Harcourt Centre
Harcourt Road
Dublin 2
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA2317