Fingolimod MSN 0.5 mg hard capsules

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Fingolimod

Prieinama:

MSN Labs Europe Limited

ATC kodas:

L04AA27

INN (Tarptautinis Pavadinimas):

Fingolimod

Vaisto forma:

Capsule, hard

Gydymo sritis:

fingolimod

Autorizacija statusas:

Not marketed

Leidimo data:

2020-11-27

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FINGOLIMOD MSN 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 MSN is and what it is used for
2.
What you need to know before you take Fingolimod MSN
3.
How to take Fingolimod MSN
4.
Possible side effects
5.
How to store Fingolimod MSN
6.
Contents of the pack and other information
1.
WHAT FINGOLIMOD MSN IS AND WHAT IT IS USED FOR
WHAT FINGOLIMOD MSN IS
Fingolimod MSN contains the active substance fingolimod.
WHAT FINGOLIMOD MSN IS USED FOR
Fingolimod MSN is used in adults 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 MSN 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.
Fingolimod is also authorised for use in children aged 10 years and
older. A fingolimod containing
drug product from a different company is registered in the European
Union. Ask your doctor or
pharmacist if you have further questions.
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 characterized by repeated att

Prekės savybės

Health Products Regulatory Authority
10 August 2022
CRN00CWP7
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fingolimod MSN 0.5 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
Capsule, hard
Hard capsules, size 3, with a white cap imprinted "0.5 mg" and a white
body imprinted "MF" with black ink. The capsules
contain a white to off-white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fingolimod MSN is indicated as single disease modifying therapy in
highly active relapsing remitting multiple sclerosis for the
following groups of adult patients:

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.
For paediatric patients aged 10 years and older a fingolimod
containing drug product from a different company is registered in
the European Union.
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 MSN is one 0.5 mg
capsule taken orally once daily.
The same first dose monitoring as for treatment initiation is
recommended when treatment is interrupted for:

1 day or more during the first 2 weeks of treatment.

more than 7 days during weeks 3 and 4 of treatment.

more than 2 weeks after one month of treatment.
If the treatment interruption is of shorter duration than the above,
the treatment should be continued with the next dose as
planned (see sect