Fingolimod 0.5 mg hard capsules

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Fingolimod

Dostopno od:

Rowa Pharmaceuticals Limited

Koda artikla:

L04AA27

INN (mednarodno ime):

Fingolimod

Odmerek:

0.5 milligram(s)

Farmacevtska oblika:

Capsule, hard

Terapevtsko območje:

fingolimod

Status dovoljenje:

Not marketed

Datum dovoljenje:

2020-08-14

Navodilo za uporabo

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FINGOLIMOD 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 is and what it is used for
2.
What you need to know before you take Fingolimod
3.
How to take Fingolimod
4.
Possible side effects
5.
How to store Fingolimod
6.
Contents of the pack and other information
1.
WHAT FINGOLIMOD IS AND WHAT IT IS USED FOR
WHAT FINGOLIMOD IS
The active substance of Fingolimod 0.5 mg Capsules is fingolimod.
WHAT FINGOLIMOD IS USED FOR
Fingolimod 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 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 disturbed b

Lastnosti izdelka

Health Products Regulatory Authority
01 July 2021
CRN00C5TD
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fingolimod 0.5 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0.5 mg fingolimod (as hydrochloride).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule
Hard gelatine capsule size "3" with a yellow opaque cap and a white
opaque body.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fingolimod 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 Fingolimodis 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 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, it is
recommended to repeat the same first dose monitoring as for
treatment initiation.
The same first dose monitoring as for treatme