Fingolimod Tillomed 0.5 mg hard capsules

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Fingolimod

Tilgængelig fra:

Tillomed Pharma GmbH

ATC-kode:

L04AA27

INN (International Name):

Fingolimod

Dosering:

0.5 milligram(s)

Lægemiddelform:

Capsule, hard

Terapeutisk område:

fingolimod

Autorisation status:

Not marketed

Autorisation dato:

2021-04-01

Indlægsseddel

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

Produktets egenskaber

Health Products Regulatory Authority
10 October 2023
CRN00DL9P
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fingolimod Tillomed 0.5 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains fingolimod hydrochloride corresponding to
0.5 mg fingolimod.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule,
Hard capsule, 15.8 mm in length with bright yellow opaque cap
imprinted with HP334 in black ink and white opaque body.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fingolimod Tillomed 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.
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.
Fingolimod Tillomed 0.5 mg hard capsules are not suitable for
paediatric patients with body weight ≤40 kg.
Other fingolimod-containing medicinal products are available in a
lower strength (as 0.25 mg capsules).
- Paediatric patients with body weight > 40 kg: one 0.5 mg capsule
taken orally once daily.
Paediatric patients who s