Inovelon

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Rufinamide

Available from:

Eisai GmbH

ATC code:

N03AF03

INN (International Name):

rufinamide

Therapeutic group:

Antiepileptics,

Therapeutic area:

Epilepsy

Therapeutic indications:

Inovelon is indicated as adjunctive therapy in the treatment of seizures associated with Lennox Gastaut syndrome in patients 4 years of age and older.

Product summary:

Revision: 23

Authorization status:

Authorised

Authorization date:

2007-01-16

Patient Information leaflet

46
B. PACKAGE LEAFLET
47
PACKAGE LEAFLET: INFORMATION FOR THE USER
INOVELON 100 MG FILM-COATED TABLETS
INOVELON 200 MG FILM-COATED TABLETS
INOVELON 400 MG FILM-COATED TABLETS
Rufinamide
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 the 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 the doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Inovelon is and what it is used for
2.
What you need to know before you take Inovelon
3.
How to use Inovelon
4.
Possible side effects
5.
How to store Inovelon
6.
Contents of the pack and other information
1.
WHAT INOVELON IS AND WHAT IT IS USED FOR
Inovelon contains a medicine called rufinamide. It belongs to a group
of medicines called
antiepileptics, which are used to treat epilepsy (a condition where
someone has seizures or fits).
Inovelon is used with other medicines to treat seizures associated
with Lennox-Gastaut syndrome in
adults, adolescents and children from 1 year of age. Lennox-Gastaut
syndrome is the name given to a
group of severe epilepsies in which you may experience repeated
seizures of various types.
Inovelon has been given to you by your doctor to reduce the number of
your seizures or fits.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE INOVELON
DO NOT TAKE INOVELON:
-
if you are allergic to rufinamide or triazole derivatives or any of
the other ingredients of
Inovelon (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist if:
-
you have Congenital Short QT Syndrome or a family history of such a
syndrome (electrical
disturbance of the heart), as taking rufinamide could make it worse.
-
you suffer from liver problems. There is l

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Inovelon 100 mg film-coated tablets
Inovelon 200 mg film-coated tablets
Inovelon 400 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oral Tablet
Each film-coated tablet contains 100 mg rufinamide.
Each film-coated tablet contains 200 mg rufinamide.
Each film-coated tablet contains 400 mg rufinamide.
Excipients with known effect:
Each 100 mg film-coated tablet contains 20 mg lactose (as
monohydrate).
Each 200 mg film-coated tablet contains 40 mg lactose (as
monohydrate).
Each 400 mg film-coated tablet contains 80 mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
100 mg: Pink, ‘ovaloid’, slightly convex, approximately 10.2 mm in
length, scored on both sides,
embossed ‘Є261’ on one side and blank on the other side. The
tablet can be divided into equal halves.
200 mg: Pink, ‘ovaloid’, slightly convex, approximately 15.2 mm in
length, scored on both sides,
embossed ‘Є262’ on one side and blank on the other side. The
tablet can be divided into equal halves.
400 mg: Pink, ‘ovaloid’, slightly convex, approximately 18.2 mm in
length, scored on both sides,
embossed ‘Є263’ on one side and blank on the other side. The
tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Inovelon is indicated as adjunctive therapy in the treatment of
seizures associated with
Lennox-Gastaut syndrome (LGS) in patients 1 year of age and older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with rufinamide should be initiated by a physician
specialised in paediatrics or neurology
with experience in the treatment of epilepsy.
Inovelon oral suspension and Inovelon film-coated tablets may be
interchanged at equal doses.
Patients should be monitored during the switch over period.
3
Posology
_USE IN CHILDREN FROM 1 YEAR TO LESS THAN 4 YEARS OF AGE_
_Patients not receiving valproate:_
Treatment should be initiated