RAXONE IDEBENONE

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

IDEBENONE

Διαθέσιμο από:

MEGAPHARM LTD

Φαρμακολογική κατηγορία (ATC):

N06BX13

Φαρμακοτεχνική μορφή:

FILM COATED TABLETS

Σύνθεση:

IDEBENONE 150 MG

Οδός χορήγησης:

PER OS

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

SANTHERA PHARMACEUTICALS (SWITZERLAND) AG., SWITZERLAND

Θεραπευτική περιοχή:

IDEBENONE

Θεραπευτικές ενδείξεις:

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

Ημερομηνία της άδειας:

2022-07-31

Φύλλο οδηγιών χρήσης

Patient Package leaflet in accordance with the Pharmacists
’Regulations (Preparations) 1986
The dispensing of this medicine requires a physician’s prescription
Raxone Idebenone
Film-coated tablets
Composition :
Active ingredient :
Idebenone 150 mg
Each tablet contains 48 mg lactose
For the complete list of the inactive ingredients and allergic
substances, please see section
2
“
Important information
about some of the drug ingredients ”and section 6
“ Additional Information .”
Read the entire leaflet carefully before using this medicine .
This leaflet contains concise information about the
medicine. If you have further questions, please consult your physician
or pharmacist.
This medicine has been prescribed for the treatment of your condition;
do not pass it on to others. It may harm them
even if you think their medical condition is similar to yours.
This medicine is intended for adults and adolescents over the age of
12 .
1.What is this medicine intended for?
Raxone Idebenone
contains an active substance called Idebenone. Idebenone is intended
for the treatment of visual
impairment in adolescents and adults with Leber’s Hereditary Optic
Neuropathy (LHON).
Therapeutic group :
This medicine affects the nervous system.
LHON is a hereditary disease that passes in the family from one
generation to another .
This disease is caused by a mutation that affects the ability of eye
cells to produce the energy they need in order to
function properly, which causes these cells not to function .
This disease may cause vision loss due to the inactivity of the eye
cells responsible for vision .
Treatment with
Raxone Idebenone
may restore the activity of energy-producing eye cells, which enables
inactive cells
to function again and improve vision .
2.Before using this medicine
Do not use the medicine if:
You are sensitive (allergic) to the active substance Idebenone or to
any of the other ingredients this medicine contains
(please see section 6 "Additional Information") .
Special warnings regarding the use of this med

Αρχείο Π.Χ.Π.

1.
NAME OF THE MEDICINAL PRODUCT
Raxone Idebenone
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 IDEBENONE 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).
No data regarding a continuous treatment with idebenone beyond 6
months is available from
controlled clinical trials.
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 not been investigated.
Caution is advised in
treatment of patients with hepatic or renal impairment (see section
4.4).
_ _
_Paediatric population _
_ _
The safety and efficacy of RAXONE IDEBENONE in LHON patients under 12
years of age have not
yet been established. Currently available data are described in
sections 5.1 and 5.2, but no
recommendation on posology can be made.
_ _
Method of administration
RAXONE IDEBENONE film-coated tablets should be swallowed whole with
water. The tablets
should not be broken or chewed. RAXONE IDEBENONE should be
administered with food because
food increases the bioavailability of idebenone.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS