Fenoxa 0,5 mg, harde capsules

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

FINGOLIMODHYDROCHLORIDE 0,6 mg/stuk SAMENSTELLING overeenkomend met ; FINGOLIMOD 0,5 mg/stuk

Beschikbaar vanaf:

Zaklady Farmaceutyczne POLPHARMA Joint-Stock Company Pelplinska 19 83 200 STAROGRAD GDANSKI (POLEN)

INN (Algemene Internationale Benaming):

FINGOLIMODHYDROCHLORIDE 0,6 mg/stuk SAMENSTELLING overeenkomend met ; FINGOLIMOD 0,5 mg/stuk

farmaceutische vorm:

Capsule, hard

Samenstelling:

GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; TRIKALIUMCITRAAT 1-WATER, GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; KALIUMCITRAAT 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2020-06-19

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
FENOXA 0,5 MG, HARDE CAPSULES
fingolimod
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 Fenoxa is and what it is used for
2.
What you need to know before you take Fenoxa
3.
How to take Fenoxa
4.
Possible side effects
5.
How to store Fenoxa
6.
Contents of the pack and other information
1
WHAT FENOXA IS AND WHAT IT IS USED FOR
WHAT FENOXA IS
The active substance of Fenoxa is fingolimod.
WHAT FENOXA IS USED FOR
Fenoxa is used in adults and in children and adolescents (10 years of
age and above) to treat relapsing-
remitting multiple sclerosis (MS), more specifically in:
-
Patients who have failed to respond despite treatment with an MS
treatment.
or
-
Patients who have rapidly evolving severe MS.
Fenoxa does not cure MS, but it helps to reduce the number of relapses
and to slow down the
progression of physical disabilities due to MS.
WHAT IS MULTIPLE SCLEROSIS
MS is a long-term condition that affects the central nervous system
(CNS), comprised of the brain and
spinal cord. In MS inflammation destroys the protective sheath (called
myelin) around the nerves in
the CNS and stops the nerves from working properly. This is called
demyelination.
Relapsing-remitting MS is characterised by repeated attacks (relapses)
of nervous system symptoms
that reflect inflammation within the CNS. Symptoms vary from patient
to patient but typically involve
walking difficulties, numbness, vision problems or disturbed balance.
Symptoms of a relapse may
disappear completely when t

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fenoxa 0,5 mg,
harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains fingolimod hydrochloride equivalent to 0.5 mg
fingolimod.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Hard gelatine capsule of 16 mm (size 3), with a white opaque body and
yellow opaque coloured cap.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fenoxa is indicated as single disease modifying therapy in highly
active relapsing remitting multiple
sclerosis for the following groups of adult patients and paediatric
patients aged 10 years and older:
-
Patients with highly active disease despite a full and adequate course
of treatment with at least
one disease modifying therapy (for exceptions and information about
washout periods see
sections 4.4 and 5.1).
or
-
Patients with rapidly evolving severe relapsing remitting multiple
sclerosis defined by 2 or more
disabling relapses in one year, and with 1 or more Gadolinium
enhancing lesions on brain MRI
or a significant increase in T2 lesion load as compared to a previous
recent MRI.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The treatment should be initiated and supervised by a physician
experienced in multiple sclerosis.
Posology
In adults, the recommended dose of Fenoxa is one 0.5 mg capsule taken
orally once daily.
In paediatric patients (10 years of age and above), the recommended
dose is dependent on body weight:
-
Paediatric patients with body weight ≤40 kg: one 0.25 mg capsule
taken orally once daily. Other
fingolimod-containing medicinal products are available in a lower
strength (as 0.25 mg capsules)
from other pharmaceutical companies.
-
Paediatric patients with body weight >40 kg: one 0.5
mg capsule taken orally once daily.
Paediatric patients who start on 0.25 mg capsules and subsequently
reach a stable body weight above
40 kg should be switched to 0.5 mg capsules.
When switching from a 0.25 mg to a 0.5 mg daily dose, it is
recommended to repeat th