Gilenya, Hard Gelatin Capsules 0.5 mg

Country: Jordan

Language: English

Source: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Active ingredient:

Fingolimod 0.5 mg

Available from:

شركة مستودع الأدوية الأردني - The Jordan Drugstore Co

ATC code:

L04AA27

INN (International Name):

Fingolimod 0.5 mg

Dosage:

0.5 mg

Units in package:

28

Manufactured by:

NOVARTIS PHARMA STEIN AG /SWI (سويسرا)

Patient Information leaflet

GILENYA
®
COMPOSITION
_Active substances _
Fingolimod as fingolimod hydrochloride
_Excipients _
0.25 mg capsules:
0.25 mg fingolimod as fingolimod hydrochloride, mannitol,
hydroxypropylcellulose, hydroxypropylbetadex, magnesium stearate,
gelatin,
titanium dioxide, yellow iron oxide, shellac, black iron oxide,
propylene
glycol, 28% ammonia solution.
0.5 mg capsules:
0.5
mg
fingolimod
as
fingolimod
hydrochloride,
mannitol,
magnesium
stearate, yellow iron oxide, titanium dioxide, gelatin, shellac,
isopropyl
alcohol, butyl alcohol, propylene glycol, purified water, 28% ammonia
solution, potassium hydroxide, black iron oxide, dimethicone.
PHARMACEUTICAL FORM AND QUANTITY OF ACTIVE SUBSTANCE PER UNIT
_Hard capsules_ containing 0.25 mg fingolimod (as hydrochloride).
_Hard capsules_ containing 0.5 mg fingolimod (as hydrochloride).
INDICATIONS/POTENTIAL USES
Gilenya is indicated for the treatment of adults, adolescents and
children aged
10 years and over with relapsing-remitting multiple sclerosis (MS) to
reduce
the frequency of relapses and delay the progression of disability.
DOSAGE/ADMINISTRATION
_General populations _
_Dosage _
In adults the recommended dose of Gilenya is one 0.5 mg capsule taken
orally
once daily with or without food.
In children and adolescents (aged 10 years and over) the recommended
dose
depends on body weight:
- Children and adolescents with a body weight of 40 kg or under: one
0.25 mg
capsule taken orally once daily.
- Children and adolescents with a body weight of over 40 kg: one 0.5
mg
capsule taken orally once daily.
“THE STRENGTH 0.25MG SUPPORTING THE AGE GROUP BETWEEN 10 AND 18
YEARS
OLD WITH BODY WEIGHT OF 40KG OR UNDER IS NOT REGISTERED”
Children and adolescents who receive 0.25 mg capsules at the start of
treatment should be switched to 0.5 mg capsules once a stable body
weight of
over 40 kg has been reached.
If a dose is missed, treatment should be continued with the next dose
as
planned.
For recommendations on switching patients from other disease-modifying
therapies or other immu