Fingolimod Denk 0.5 mg hard capsules

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

FINGOLIMOD

Prieinama:

Denk Pharma GmbH & Co. KG Prinzregentenstrasse 79 81675 München , Germany

ATC kodas:

L04AA27

INN (Tarptautinis Pavadinimas):

FINGOLIMOD 0.5 mg

Vaisto forma:

HARD CAPSULE

Sudėtis:

FINGOLIMOD 0.5 mg

Recepto tipas:

POM

Gydymo sritis:

IMMUNOSUPPRESSANTS

Produkto santrauka:

Licence number in the source country: NOT APPLICAPABLE

Autorizacija statusas:

Authorised

Leidimo data:

2021-02-18

Pakuotės lapelis

PAGE 1 OF 12
PACKAGE LEAFLET: INFORMATION FOR THE USER
FINGOLIMOD DENK 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 Denk is and what it is used for
2.
What you need to know before you take Fingolimod Denk
3.
How to take Fingolimod Denk
4.
Possible side effects
5.
How to store Fingolimod Denk
6.
Contents of the pack and other information
1.
WHAT FINGOLIMOD DENK IS AND WHAT IT IS USED FOR
WHAT FINGOLIMOD DENK IS
Fingolimod Denk contains the active substance fingolimod.
WHAT FINGOLIMOD DENK IS USED FOR
Fingolimod Denk 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 Denk 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 di

Prekės savybės

PAGE 1 OF 26
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fingolimod Denk 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
Capsule of 15.9 mm with yellow opaque cap and white opaque body;
imprinted with black ink “FD
0.5 mg” on cap.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Fingolimod Denk 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: 0.25 mg fingolimod
taken orally once daily.
(For these patients appropriate strengths and/or dosage forms from
other pharmaceutical
companies are available.)
-
Paediatric patients with body weight >40 kg: 0.5 mg fingolimod taken
orally once daily.
PAGE 2 OF 26
Paediatric patients who start on 0.25 mg fingolimod and subsequently
reach a stable body weight
above 40 kg should be switched to 0.5 mg fingolimod.
When switching from a 0.25 mg to a 0.5 mg daily dose, it is
recomme