Fingolimod Remedica 0.5 mg hard capsules

Země: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Dostupné s:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC kód:

L04AA27

INN (Mezinárodní Name):

FINGOLIMOD 0.5 mg

Léková forma:

HARD CAPSULE

Složení:

FINGOLIMOD 0.5 mg

Druh předpisu:

POM

Terapeutické oblasti:

IMMUNOSUPPRESSANTS

Stav Autorizace:

Authorised

Datum autorizace:

2024-01-16

Informace pro uživatele

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FINGOLIMOD REMEDICA 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 Fingolimod Remedica is and what it is used for
2.
What you need to know before you take Fingolimod Remedica
3.
How to use Fingolimod Remedica
4.
Possible side effects
5.
How to store Fingolimod Remedica
6.
Contents of the pack and other information
1.
WHAT FINGOLIMOD REMEDICA
IS AND WHAT IT IS USED FOR
WHAT FINGOLIMOD REMEDICA
IS
Fingolimod Remedica contains the active substance fingolimod.
WHAT FINGOLIMOD REMEDICA
IS USED FOR
Fingolimod Remedica 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.
Fingolimod Remedica 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

Charakteristika produktu

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_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Fingolimod Remedica 0.5 mg hard capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains fingolimod hydrochloride equivalent to 0.5
mg fingolimod.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Hard capsules.
Hard capsules of 15.9 mm, with white to off-white body and yellow cap,
with ‘C886’
marking in black ink on the cap.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fingolimod Remedica 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 fingolimod is one 0.5 mg capsule
taken orally once
daily.
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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 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,