MAYZENT 0.25 MG

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

SIPONIMOD AS FUMARIC ACID

Tilgængelig fra:

NOVARTIS ISRAEL LTD

ATC-kode:

L04AA42

Lægemiddelform:

FILM COATED TABLETS

Sammensætning:

SIPONIMOD AS FUMARIC ACID 0.25 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

Terapeutisk område:

SIPONIMOD

Terapeutiske indikationer:

Mayzent is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease, and active secondary progressive disease, in adults.

Autorisation dato:

2020-10-26

Indlægsseddel

If you have any side effects, talk to your doctor, pharmacist or
nurse.
This includes any possible side effects not listed in the package
leaflet.
6 Tozeret Haaretz street, P.O.Box 7126, Tel Aviv Tel: [phone], Fax:
03-9229230
RMP 2023-007 ENG
_PATIENT AND _
_CAREGIVER GUIDE_
_IMPORTANT THINGS TO REMEMBER ABOUT _
_YOUR MAYZENT (SIPONIMOD) TREATMENT_
REPORTING ADVERSE EVENTS
Adverse events can be reported to the Ministry of Health via:
https://sideeffects.health.gov.il
You may also report to the registration holder,
Novartis Israel LTD. at: [e-mail]
This guide was approved according to the guidelines of the ministry of
health on
27
th
October 2023
®
2
3
_CONTENTS:_
Introduction............................................................................................................................................4
What is MS (multiple
sclerosis).........................................................................................................4
What is Mayzent and how it
works....................................................................................................4
Before you take Mayzent
...................................................................................................................5
The first time you take
Mayzent........................................................................................................6
Starting your treatment with
Mayzent.............................................................................................6
Mayzent medication
schedule...........................................................................................................7
During treatment with
Mayzent.........................................................................................................7
Side effects and important
risks..................................................................................................8-10
Female
patients.............................................................................................

Produktets egenskaber

MAY API AUG23 V6
Page 1 of 23
EU SmPC Jul.2023
1.
NAME OF THE MEDICINAL PRODUCT
Mayzent 0.25 mg
Mayzent 2 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mayzent 0.25 mg, film-coated tablets
Each film-coated tablet contains siponimod fumaric acid equivalent to
0.25 mg siponimod.
_Excipient with known effect _
Each tablet contains 62.197 mg lactose monohydrate and 0.092 mg
lecithin (soya).
Mayzent 2 mg, film-coated tablets
Each film-coated tablet contains siponimod fumaric acid equivalent to
2 mg siponimod.
_Excipient with known effect _
Each tablet contains 60.251 mg lactose monohydrate and 0.092 mg
lecithin (soya).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Film-coated tablet
Mayzent 0.25 mg, film-coated tablets
Pale red, unscored, round, biconvex, bevelled-edged film-coated tablet
of approximately 6.1 mm
diameter with company logo on one side and
“
T
”
on the other side.
Mayzent 2 mg, film-coated tablets
Pale yellow, unscored, round, biconvex, bevelled-edged film-coated
tablet of approximately 6.1 mm
diameter with company logo on one side and
“
II
”
on the other side.
4.
CLINICAL
PARTICULARS
Patient/Caregiver Guide and Pregnancy Reminder Card
The marketing of Mayzent is subject to a risk management plan (RMP)
including
‘
Patient/Caregiver Guide
’ and ‘
Pregnancy Reminder C
ard’. These cards emphasize important
safety information that the patient should be aware of before and
during treatments. Please
explain to the patient the need to review the card/s before starting
treatment.
PHYSICIAN’S CHECKLIST
This product is marketed with
Physician’s
Checklist providing important safety information.
Please ensure you are familiar with this material as it contains
important safety information.
4.1
THERAPEUTIC INDICATIONS
Mayzent is indicated for the treatment of relapsing forms of multiple
sclerosis (MS), to include
relapsing-remitting disease, and active secondary progressive disease,
in adults.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with siponimod should