Trileptal 600 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Oxcarbazepine

Available from:

IMED Healthcare Ltd.

ATC code:

N03AF; N03AF02

INN (International Name):

Oxcarbazepine

Dosage:

600 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Carboxamide derivatives; oxcarbazepine

Authorization date:

2021-01-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 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 r

Summary of Product characteristics

Health Products Regulatory Authority
15 January 2021
CRN00C0PD
Page 1 of 2
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.
Product imported from _Bulgaria_
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
As per PA0896/033/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0896/033/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core:
Silica, colloidal anhydrous
Cellulose, microcrystalline
Hypromellose
Crospovidone
Magnesium stearate
Tablet coating:
Hypromellose
Talc
Titanium dioxide (E 171)
Macrogol 4000
Iron oxide red (E 172)
Iron oxide black (E 172)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
Health Products Regulatory Authority
15 January 2021
CRN00C0PD
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
Blister containing 10 tablets.
Blister pack of 50 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/154/003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 15
th
January 2021
10 DATE OF REVISION OF THE TEXT