Gilenya
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
15-09-2023
Charakterystyka produktu
(SPC)
15-09-2023
Sprawozdanie z oceny publicznego
(PAR)
18-12-2018
Składnik aktywny:
fingolimod hydrochloride
Dostępny od:
Novartis Europharm Limited
Kod ATC:
L04AA27
INN (International Nazwa):
fingolimod
Grupa terapeutyczna:
Immunosuppressants
Dziedzina terapeutyczna:
Multiple Sclerosis
Wskazania:
Gilenya 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).orPatients 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.
Podsumowanie produktu:
Revision: 36
Status autoryzacji:
Authorised
Data autoryzacji:
2011-03-17
Ulotka dla pacjenta
61
B. PACKAGE LEAFLET
62
PACKAGE LEAFLET: INFORMATION FOR THE USER
GILENYA 0.25 MG HARD CAPSULES
GILENYA 0.5 MG HARD 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 Gilenya is and what it is used for
2.
What you need to know before you take Gilenya
3.
How to take Gilenya
4.
Possible side effects
5.
How to store Gilenya
6.
Contents of the pack and other information
1.
WHAT GILENYA IS AND WHAT IT IS USED FOR
WHAT GILENYA IS
Gilenya contains the active substance fingolimod.
WHAT GILENYA IS USED FOR
Gilenya 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.
Gilenya 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 distu
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Gilenya 0.25 mg hard capsules
Gilenya 0.5 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gilenya 0.25 mg hard capsules
Each 0.25 mg capsule contains 0.25 mg fingolimod (as hydrochloride).
Gilenya 0.5 mg hard capsules
Each 0.5 mg capsule contains 0.5 mg fingolimod (as hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Gilenya 0.25 mg hard capsules
Capsule of 16 mm with ivory opaque cap and body, with black radial
imprint “FTY 0.25mg” on cap
and black radial band on body.
Gilenya 0.5 mg hard capsules
Capsule of 16 mm with bright yellow opaque cap and white opaque body;
imprint with black ink,
“FTY0.5 mg” on cap and two radial bands imprinted on the body with
yellow ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gilenya 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.
3
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 fingolimod 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.
-
Paediatric patients with body
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