Fingolimod Teva 0.5 mg hard capsules

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Fingolimod

Saadav alates:

Teva B.V.

ATC kood:

L04AA27

INN (Rahvusvaheline Nimetus):

Fingolimod

Annus:

0.5 milligram(s)

Ravimvorm:

Capsule, hard

Terapeutiline ala:

fingolimod

Volitamisolek:

Not marketed

Loa andmise kuupäev:

2020-11-20

Infovoldik

2
PACKAGE LEAFLET: INFORMATION FOR THE USER
[PRODUCT NAME] 0.25 MG HARD CAPSULES
[PRODUCT NAME] 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 [Product name] is and what it is used for
2.
What you need to know before you take [Product name]
3.
How to take [Product name]
4.
Possible side effects
5.
How to store [Product name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
WHAT [PRODUCT NAME] IS
The active substance of [Product name] is fingolimod.
WHAT [PRODUCT NAME] IS USED FOR
[Product name] 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.
[Product name] 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 in

Toote omadused

Health Products Regulatory Authority
20 November 2020
CRN0093G2
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fingolimod Teva 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
Gelatin capsules of approximately 14 mm imprinted in black, with "TEVA
7820" on the yellow capsule cap and "TEVA 7820" on
the white opaque capsule body.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fingolimod Teva 0.5 mg hard capsules 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 Teva 0.5 mg hard
capsules 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.
-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, i