Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
SIPONIMOD AS FUMARIC ACID
NOVARTIS ISRAEL LTD
L04AA42
FILM COATED TABLETS
SIPONIMOD AS FUMARIC ACID 0.25 MG
PER OS
Required
NOVARTIS PHARMA STEIN AG, SWITZERLAND
SIPONIMOD
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.
2020-10-26
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: 03-9201111, 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: safetydesk.israel@novartis.com 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............................................................................................. Olvassa el a teljes dokumentumot
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 Olvassa el a teljes dokumentumot