Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Ondansetron
Novartis Ireland Limited
A04AA; A04AA01
Ondansetron
4 milligram(s)
Oral lyophilisate
Product subject to prescription which may not be renewed (A)
Serotonin (5HT3) antagonists; ondansetron
Marketed
1998-07-13
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ZOFRAN® ZYDIS 4 MG AND 8 MG ORAL LYOPHILISATE ondansetron READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions about your illness or your medicine, ask your doctor, nurse or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1 What Zofran Zydis is and what it is used for 2 What you need to know before you take Zofran Zydis 3 How to take Zofran Zydis 4 Possible side effects 5 How to store Zofran Zydis 6 Contents of the pack and other information 1. WHAT ZOFRAN ZYDIS IS AND WHAT IT IS USED FOR Zofran Zydis contains a medicine called ondansetron. This belongs to a group of medicines called anti-emetics. Zofran Zydis is a special type of Zofran tablet that dissolves very quickly when put on top of the tongue. Zofran Zydis is used for: • preventing nausea and vomiting caused by chemotherapy or radiotherapy for cancer in ADULTS • preventing nausea and vomiting after surgery in ADULTS • preventing nausea and vomiting caused by chemotherapy for cancer in CHILDREN AND ADOLESCENTS aged 6 months to 17 years Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses. Zofran Zydis should start to work within one or two hours of taking a dose. You must talk to a doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOFRAN ZYDIS DO NOT TAKE ZOFRAN ZYDIS IF: • if you are taking apomorphine (used to treat Parkinson’s Disease) • you are allergic (hypersensitive) to ondansetron or any of the other ingredients in Zofran Zydis (listed in Section 6). If you are not sure, t Прочитајте комплетан документ
Health Products Regulatory Authority 17 June 2022 CRN00CV6M Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zofran Zydis 4 mg oral lyophilisate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Zofran Zydis oral lyophilisate contains ondansetron 4 mg Excipients with known effect: Each 4 mg Oral Lyophilisate contains 625 micrograms of aspartame (E951), 56 micrograms sodium methyl parahydroxybenzoate (E219) 6.9 micrograms of sodium propyl parahydroxybenzoate (E217). 0.031 mg Ethanol For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral lyophilisate. White round tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULTS Zofran Zydis is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Zofran Zydis is also indicated for the prevention of post-operative nausea and vomiting. PAEDIATRIC POPULATION Orally administered Zofran is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy in children and adolescents aged from 6 months to 17 years. No studies have been conducted in children on the use of orally administered Zofran in the prevention or treatment of post-operative nausea and vomiting; IV injection may be recommended for this purpose. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Zofran is also available for parenteral and rectal use to allow the route of administration and dosing to be flexible. Place the Zofran Zydis on top of the tongue, where it will disperse within seconds, then swallow. CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING (CINV AND RINV): The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The selection of dose regimen should be determined by the severity of the emetogenic challenge. _CINV AND RINV IN ADULTS:_ The recommended oral dose is 8mg taken 1-2 hours before chemotherapy or radiation treatment, followed by 8mg orally every 12 hours for a maximum of 5 days. H Прочитајте комплетан документ