Fingolimod Krka 0.5 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FINGOLIMOD HYDROCHLORIDE

Available from:

KRKA, d.d., Novo mesto

ATC code:

L04AA27

INN (International Name):

FINGOLIMOD HYDROCHLORIDE

Dosage:

0.5 milligram(s)

Pharmaceutical form:

Capsule, hard

Therapeutic area:

fingolimod

Authorization status:

Not marketed

Authorization date:

2021-02-12

Patient Information leaflet

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

Summary of Product characteristics

Health Products Regulatory Authority
09 November 2023
CRN00DQQM
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fingolimod Krka 0.5 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains fingolimod hydrochloride equivalent to 0.5
mg fingolimod.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule (capsule)
Capsule cap is brown-yellow with black mark F 0.5 mg and with black
company logo. Capsule body is white. Capsule content is
white or almost white powder. Capsule length: 15 – 17 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fingolimod Krka 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.

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