Fingolimod Pharmathen 0.5 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fingolimod

Available from:

Pharmathen S.A.

ATC code:

L04AA27

INN (International Name):

Fingolimod

Dosage:

0.5 milligram(s)

Pharmaceutical form:

Capsule, hard

Therapeutic area:

fingolimod

Authorization status:

Not marketed

Authorization date:

2021-04-09

Patient Information leaflet

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

Summary of Product characteristics

Health Products Regulatory Authority
27 January 2023
CRN00CV5Q
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fingolimod Pharmathen 0.5 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 0.5 mg fingolimod (as hydrochloride).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule
White to off-white powder in a yellow opaque cap and white opaque body
size No 3 hard gelatin capsule with length 15.9 ±
0.3 mm, imprinted with "0.5 mg" on the cap with black ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fingolimod Pharmathen is indicated as single disease modifying therapy
in highly active relapsing-remitting multiple sclerosis
(MS) 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 Pharmathen is one 0.5 mg
hard capsule once daily.
In paediatric patients (10 years of age and above), the recommended
dose is dependent on body weight:
In paediatric patients with body weight > 40 kg, the recommended dose
of Fingolimod Pharmathen is one 0.5 mg hard capsule
once daily.
Other pharmaceutical strengths are more appropriate for administration
to paediatric patients 10 years of age and above with
body weight ≤ 40 kg.
The same first dose monitoring as for treatment initiation is
recommended when treatment is inte