Fimodigo 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:

Vipharm S.A. ul. A. i F. Radziwillow 9 05-850 OZARÓW MAZOWIECKI (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

M1.3.1_03.FGD.hcl.cap.100.04.NL.4803.02
PACKAGE LEAFLET: INFORMATION FOR THE USER
FIMODIGO 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 FIMODIGO is and what it is used for
2.
What you need to know before you take FIMODIGO
3.
How to take FIMODIGO
4.
Possible side effects
5.
How to store FIMODIGO
6.
Contents of the pack and other information
1
WHAT FIMODIGO IS AND WHAT IT IS USED FOR
WHAT FIMODIGO IS
The active substance of FIMODIGO is fingolimod.
WHAT FIMODIGO IS USED FOR
FIMODIGO 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.
FIMODIGO 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

Productkenmerken

M1.3.1_01.FGD.hcl.cap.100.04.NL.4803.02
SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAME OF THE MEDICINAL PRODUCT
FIMODIGO 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
FIMODIGO 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 FIMODIGO 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