Chantico 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:

G.L. Pharma GmbH Schlossplatz 1 A-8502 LANNACH (OOSTENRIJK)

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 (E 332), 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:

1900-01-01

Bijsluiter

M1.3.1_03.FGD.hcl.cap.105.04.NL.4801.02
PACKAGE LEAFLET: INFORMATION FOR THE USER
CHANTICO 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 Chantico is and what it is used for
2.
What you need to know before you take Chantico
3.
How to take Chantico
4.
Possible side effects
5.
How to store Chantico
6.
Contents of the pack and other information
1
WHAT CHANTICO IS AND WHAT IT IS USED FOR
WHAT CHANTICO IS
Chantico contains the active substance fingolimod.
WHAT CHANTICO IS USED FOR
Chantico 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.
Chantico 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 disturbe

Productkenmerken

Common Technical Document
Fingolimod (as hydrochloride) 0.5 mg
Capsules
M1.3.1_01.FGD.hcl.cap.105.04.Core
Page 1 of 27
1.3.1
Summary of Product Characteristics - Core
1.
NAAM VAN HET GENEESMIDDEL
Chantico 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
[Product name] 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 [Product name] 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.
Common Technical Document
Fingolimod (as hydrochloride) 0.5 mg
Capsules
M1.3.1_01.FGD