Gilenya 0.5mg Hard Capsule

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Fingolimod hydrochloride

Available from:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International Name):

Fingolimod hydrochloride

Units in package:

28capsule Capsules; 7capsule Capsules; 98capsule Capsules

Manufactured by:

NOVARTIS PHARMA STEIN AG

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (PIL)_
GILENYA
®
HARD CAPSULES
Fingolimod 0.25 mg & 0.5 mg
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Gilenya is used for
2.
How Gilenya works
3.
Before you use Gilenya
4.
How to use Gilenya
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Gilenya
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT GILENYA IS USED FOR
Gilenya is a prescription medicine taken
orally, and is used in adults, children and
adolescents (10 years of age and above)
to treat relapsing forms of multiple
sclerosis (MS).
Gilenya does not cure MS, but it helps to
reduce the number of relapses that occur
and to slow the build-up of physical
problems due to MS (disability
progression).
HOW GILENYA WORKS
Gilenya can alter the way the body’s
immune system works, and help to fight
against attacks of the immune system by
affecting the ability of some white blood
cells to move freely within the body and
by stopping the cells that cause
inflammation from reaching the brain.
This reduces nerve damage caused by
MS. Gilenya may also have a direct and
beneficial effect on certain brain cells
(neural cells) involved in repairing or
slowing down the damage caused by MS.
In clinical studies Gilenya has been
shown to cut down the number of attacks
(by slightly more than half in adults and
by slightly more than three quarters in
children/adolescents) and as a
consequence, to reduce the number of
severe relapses and relapses that must be
treated in hospital, to prolong the time
without relapses and to slow the
progression of disability (by about a third
in adults and by about three quarters in
children/adolescents).
If you have any questions about how
Gilenya works or why this medicine has
been prescribed for you or your child,
ask your doctor.
BEFORE YOU USE GILENYA
-
_When you must not use it _
Do not take Gilenya if you:

have had a heart attack, unstable
angina, stroke or mini-stroke
(transient ischemic attack or TIA) or
certain type

Summary of Product characteristics

Novartis
Page 2
Malaysia Package Insert
06-Jun-2019
Gilenya
GILENYA
®
Immunomodulator
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Gilenya is available as:

0.25 mg hard capsules with an ivory opaque body and cap, with black
radial imprint “FTY
0.25mg” on the cap and a black radial band on the capsule body.

0.5 mg hard capsules with a white opaque body and bright yellow cap
imprinted with “FTY
0.5 mg” on the cap and 2 radial bands imprinted on the capsule body
with yellow ink.
ACTIVE SUBSTANCE
0.25 mg hard capsules: Each capsule contains 0.25 mg fingolimod (as
hydrochloride).
0.5 mg hard capsules: Each capsule contains 0.5 mg fingolimod (as
hydrochloride).
Fingolimod hydrochloride is a synthetic analogue of sphingosine. The
chemical designation is 2-
amino-2[2-(4-octylphenyl)ethyl]propane-1,3-diol
hydrochloride.
Its
molecular
formula
is
C
19
H
33
NO
2
-HCl and it has a molecular weight of 343.93.
Fingolimod hydrochloride is a white to almost white powder which is
freely soluble in water.
ACTIVE MOIETY
Fingolimod
EXCIPIENTS
0.25
mg
hard
capsules:
mannitol,
hydroxypropylcellulose,
hydroxypropylbetadex,
magnesium
stearate, gelatin, titanium dioxide, iron oxide yellow.
0.5 mg hard capsules: mannitol, magnesium stearate, gelatin, titanium
dioxide, iron oxide yellow.
Pharmaceutical formulations may vary between countries.
INDICATIONS
Gilenya is indicated for the treatment of adult patients and pediatric
patients of 10 years of age and
above
with
relapsing
forms
of
multiple
sclerosis
(MS)
to
reduce
the
frequency
of
clinical
exacerbations and to delay the accumulation of physical disability.
DOSAGE AND ADMINISTRATION
ASSESSMENT PRIOR TO INITIATING GILENYA
Cardiac Evaluation
Obtain a cardiac evaluation in patients with certain preexisting
conditions (see WARNINGS &
PRECAUTIONS).
Prior to starting treatment, determine whether patients are taking
drugs that could slow heart rate or
atrioventricular
(AV)
conduction
[see
DOSAGE
AND
ADMINISTRATIONS
&
DRUG
INTERACTIONS)
Complete Blood Count (CBC)
Novartis
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