Fingolimod Genthon 0.5 mg, hard capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FINGOLIMOD

Available from:

Genthon BV Microweg 22, 6545 CM NIJMEGEN, Netherlands

ATC code:

L04AA27

INN (International Name):

FINGOLIMOD 0.5 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

FINGOLIMOD 0.5 mg

Prescription type:

POM

Therapeutic area:

IMMUNOSUPPRESSANTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Withdrawn

Authorization date:

2020-07-10

Patient Information leaflet

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

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fingolimod Genthon 0.5 mg, hard 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
Fingolimod Genthon 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 Genthon 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.
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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