Fingolimod Clonmel 0.5 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fingolimod

Available from:

Clonmel Healthcare Ltd

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:

2021-01-29

Patient Information leaflet

Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE USER
FINGOLIMOD CLONMEL 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 Clonmel is and what it is used for
2. What you need to know before you take Fingolimod Clonmel
3. How to take Fingolimod Clonmel
4. Possible side effects
5. How to store Fingolimod Clonmel
6. Contents of the pack and other information
1. WHAT FINGOLIMOD CLONMEL IS AND WHAT IT IS USED FOR
WHAT FINGOLIMOD CLONMEL IS
The active substance of Fingolimod Clonmel is fingolimod.
WHAT FINGOLIMOD CLONMEL IS USED FOR
Fingolimod Clonmel is used in adults, adolescents and children aged 10
years and older and with a body
weight > 40 kg 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 Clonmel 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

Summary of Product characteristics

Health Products Regulatory Authority
22 April 2021
CRN00C767
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fingolimod Clonmel 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
Hard gelatine capsule of 13.53 mm with a yellow opaque cap and a white
opaque body.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fingolimod Clonmel 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 and with a body weight > 40 kg:
-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)
-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 0.5 mg taken orally
once daily.
In paediatric patients (10 years of age and above), the recommended
dose is dependent on body weight:

In paediatric patients with a body weight > 40 kg: the recommended
dose is 0.5 mg taken orally once daily.

In paediatric patients with body weight ≤ 40 kg: Fingolimod Clonmel
is not suitable. Other fingolimod-containing
medicinal products are available in a lower strength (as 0.25 mg
capsules).
When switching from a 0.25 mg to a 0.5 mg daily dose, it is
recommended to repeat the same first dose monitoring as for
treatment initiation.
The same first dose monitoring as