Raxone

Země: Evropská unie

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktivní složka:

idebenone

Dostupné s:

Chiesi Farmaceutici S.p.A

ATC kód:

N06BX13

INN (Mezinárodní Name):

idebenone

Terapeutické skupiny:

Other psychostimulants and nootropics, Psychoanaleptics,

Terapeutické oblasti:

Optic Atrophy, Hereditary, Leber

Terapeutické indikace:

Raxone is indicated for the treatment of visual impairment in adolescent and adult patients with Leber’s Hereditary Optic Neuropathy (LHON).

Přehled produktů:

Revision: 9

Stav Autorizace:

Authorised

Datum autorizace:

2015-09-08

Informace pro uživatele

19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET: INFORMATION FOR THE USER
RAXONE 150 MG FILM-COATED TABLETS
idebenone
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Raxone is and what it is used for
2.
What you need to know before you take Raxone
3.
How to take Raxone
4.
Possible side effects
5.
How to store Raxone
6.
Contents of the pack and other information
1.
WHAT RAXONE IS AND WHAT IT IS USED FOR
Raxone contains a substance called idebenone.
Idebenone is used to treat vision impairment in adults and adolescents
with an eye disease called
Leber’s Hereditary Optic Neuropathy (LHON).
-
This eye problem is inherited – this means it runs in families.
-
It is caused by a problem with your genes (called a “genetic
mutation”) that affects the ability of
cells in the eye to produce the energy they need to work normally, so
they become inactive.
-
LHON can lead to loss of eyesight due to the inactivity of cells
responsible for vision.
Treatment with Raxone can restore the ability of cells to produce
energy and so allow inactive eye
cells to work again. This can lead to some improvement in lost
eyesight.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAXONE
DO NOT TAKE RAXONE
-
if you are allergic to idebenone or any of the other ingredients of
this medicine (listed in
section 6).

Charakteristika produktu

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Raxone 150 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg idebenone.
Excipients with known effect
Each film-coated tablet contains 46 mg of lactose (as monohydrate) and
0.23 mg of sunset yellow FCF
(E110).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Orange, round, biconvex film-coated tablet of 10 mm diameter, engraved
with the Santhera logo on
one side and ‘150’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Raxone is indicated for the treatment of visual impairment in
adolescent and adult patients with
Leber’s Hereditary Optic Neuropathy (LHON) (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Treatment should be initiated and supervised by a physician with
experience in LHON.
Posology
_ _
The recommended dose is 900 mg/day idebenone (300 mg, 3 times a day).
Data regarding continuous treatment with idebenone for up to 24 months
are available as part of a
Natural History controlled open label clinical trial (see section
5.1).
Special populations
_ _
_Elderly _
No specific dose adjustment is required for the treatment of LHON in
elderly patients.
_ _
_Hepatic or renal impairment _
Patients with hepatic or renal impairment have been investigated.
However, no specific posology
recommendations can be made. Caution is advised in treatment of
patients with hepatic or renal
3
impairment, since adverse events have resulted in temporary
interruption or discontinuation of
treatment (see section 4.4).
In the absence of sufficient clinical data, caution should be
exercised in patients with renal
impairment.
_ _
_Paediatric population _
The safe