Inovelon 40mgml oral suspension

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Rufinamide

Disponibil de la:

Eisai Ltd

Codul ATC:

N03AF03

INN (nume internaţional):

Rufinamide

Dozare:

40mg/1ml

Forma farmaceutică:

Oral suspension

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: ; GTIN: 5036519000588

Prospect

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
INOVELON 40 MG/ML ORAL SUSPENSION
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 over 4 years 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:
-
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 limited information on the
use of rufinamide in this
group, so the dose of your medicine may need to

Caracteristicilor produsului

OBJECT 1
INOVELON ORAL SUSPENSION
Summary of Product Characteristics Updated 25-Jan-2017 | Eisai Ltd
1. Name of the medicinal product
Inovelon 40 mg/ml oral suspension
2. Qualitative and quantitative composition
Each ml of oral suspension contains 40 mg rufinamide.
1 bottle of 460 ml contains 18400 mg rufinamide.
Excipients with known effect:
Each ml of oral suspension contains:
1.2 mg methyl parahydroxybenzoate (E218),
0.3 mg propyl parahydroxybenzoate (E216),
250 mg sorbitol (E420)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral suspension.
White, slightly viscous suspension.
4. Clinical particulars
4.1 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.
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.
Posology
_Use in children four years of age or older and less than 30 kg_
Patients <30 kg not receiving valproate:
Treatment should be initiated at a daily dose of 200 mg (5 ml dosing
suspension given as two 2.5 ml
doses, one in the morning and one in the evening). According to
clinical response and tolerability, the
dose may be increased by 200 mg/day increments, as frequently as every
two days, up to a maximum
recommended dose of 1000 mg/day (25 ml/day). Doses of up to 3600
mg/day (90 ml/day) have been
studied in a limited number of patients.
Patients <30 kg also receiving valproate:
As valproate significantly decreases clearance of rufinamide, a lower
maximum dose of Inovelon is
recommended for patients <30 kg being co-administered valproate.
Treatment should be initiated at a
daily dose of 200 mg. According to clinical response and tolerability,
after a minimum of 2 days