GILENYA 0.5 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FINGOLIMOD AS HYDROCHLORIDE

Available from:

NOVARTIS ISRAEL LTD

ATC code:

L04AA27

Pharmaceutical form:

HARD CAPSULE

Composition:

FINGOLIMOD AS HYDROCHLORIDE 0.5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

Therapeutic group:

FINGOLIMOD

Therapeutic area:

FINGOLIMOD

Therapeutic indications:

Gilenya is indicated for the treatment of patients with relapsing forms of multiple sclerosis ( MS ) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.

Authorization date:

2016-03-31

Patient Information leaflet

ةيئاودلا ةعرجلا لوانت لبق بلقلل
يئابرهكلا طيطختلا صحف
∙
ةيئاودلا ةعرجلا لوانت دعب ةعاس لك مدلا
طغضو ضبنلا صوحف
∙
ةيئاودلا ةعرجلا لوانت نم تاعاس 6 دعب
بلقلل يئابرهكلا طيطختلا صحف
∙
جلاعلا نع فقوتلا
.بيبطلا ةيصوت بسح جلاعلا ىلع ةبظاوملا
بجي
نسحت أرط ولو ىتح ،بيبطلا ةراشتسإ نودب
ءاودلاب جلاعلا نع فقوتلا زوجي لا
.ةيحصلا كتلاح ىلع
رظنأ ـ مقافتتو دوعت دق ددعتملا بلصتلا
ضارعأ نإف ،ءاودلا لوانت نع تفقوت اذإ
ةرقف يف »اينيليﭼ نع فقوتلا دعب
ددعتملا بلصتلا ضرم يف ديدش مقافت«
دنبلا
.ةيبناجلا ضارعلأا ةعرجلا نم دكأتلاو ءاودلا عبﺎط صيخشت
بجي
!
ةمتعلا يف ةيودلأا لوﺎﻨتت لا
.
ءاود ﺎهيف لوﺎﻨتت
ةرم لك يف
ةيئاودلا
.
كلذ رملأا مزل اذإ ةيبطلا تارﺎظﻨلا
عض وأ بيبطلا رشتسإ ،ءاودلا لﺎمعتسإ لوح
ةيفﺎضإ ةلئسأ كيدل ترفوت اذإ
.يلديصلا
ةيبنﺎجلا ضارعلأا )4
.نيلمعتسملا ضعب دنع ةيبناج
ً
اضارعأ ببسي دق اينيليﭼ لامعتسإ نإ
،ءاود لكب امك
.اهنم
ً
ايأ يناعت لاأ زئاجلا نم ،ةيبناجلا
ضارعلأا ةمئاق نم شهدنت لا
:لمشت ،ةيدج ةيبنﺎج
ً
ﺎضارعأ ﺎيﻨيليﭼ ببسي دق ءدب دﻨع )bradyarrythmia وأ bradycardia( ءيطب بلق
مظن
∙
ﺎيﻨيليﭼ كلوﺎﻨت
ةيئاودلا ةعرجلا كلوانت دعب ةصاخ ،كبلق
مظن ؤطابت ىلإ يدؤت نأ اينيليﭼ ناكمإب
اذإ ىفشتسم برقأ يف ئراوطلا ةفرغ ىلإ وأ
كبيبط ىلإ
ً
اروف هجوت .ىلو�

Summary of Product characteristics

GIL API NOV23 V 10.1
Page 1 of 22
USPI Aug.2023, EU SmPC Dec.2022
PRESCRIBING INFORMATION
1
NAME OF THE MEDICINAL PRODUCT
Gilenya 0.5 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
GILENYA is provided as 0.5 mg hard gelatin capsules for oral use.
Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride,
equivalent to 0.5 mg of fingolimod.
For the full list of excipients, see section 12.
3
PHARMACEUTICAL FORM
Hard capsule.
Hard capsules with a white opaque body and bright yellow opaque cap;
radial imprint in black ink
“FTY 0.5 mg”
on the cap and 2 radial bands imprinted on the capsule body with
yellow ink.
Fingolimod hydrochloride is a white to almost white crystalline
powder.
PATIENT/CAREGIVER GUIDE AND PREGNANCY REMINDER CARD
The marketing of Gilenya 0.5 mg is subject to a risk management plan
(RMP) including a 'Patient/Caregiver guide'
and a 'Pregnancy reminder card'.
These materials emphasize important safety information that the
patient should be aware of before and during
treatment.
Please explain to the patient the need to review these materials
before starting treatment.
PHYSICIAN'S CHECKLIST
This product is marketed with a 'physician's checklist' providing
important safety information.
Please ensure you are familiar with this material as it contains
important safety information.
4
THERAPEUTIC INDICATIONS
Gilenya is indicated for the treatment of patients with relapsing
forms of multiple sclerosis (MS) to reduce the frequency
of clinical exacerbations and to delay the accumulation of physical
disability.
5
DOSAGE AND ADMINISTRATION
GENERAL TARGET POPULATION
The recommended dose of Gilenya is one 0.5 mg capsule taken orally
once daily, which can be taken with or without
food.
If a dose is missed, treatment should be continued with the next dose
as planned.
Before initiating treatment with Gilenya, a recent complete blood
count (CBC) (i.e. within 6 months or after
discontinuation of prior therapy) should be available. Assessments of
CBC are also recommended periodically during
treatment, at month