Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Ondansetron
IMED Healthcare Ltd.
A04AA; A04AA01
Ondansetron
4 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Serotonin (5HT3) antagonists; ondansetron
Authorised
2012-06-22
PACKAGE LEAFLET: INFORMATION FOR THE USER ZOFRAN 4MG FILM-COATED TABLETS 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. See section 4. WHAT IS IN THIS LEAFLET: 1. What Zofran tablets are and what they are used for 2. What you need to know before you take Zofran tablets 3. How to take Zofran tablets 4. Possible side effects 5. How to store Zofran tablets 6. Contents of the pack and other information 1. WHAT ZOFRAN TABLETS ARE AND WHAT THEY ARE USED FOR Zofran tablets contain a medicine called ondansetron. This belongs to a group of medicines called anti-emetics. Zofran tablets are 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 tablets 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 TABLETS DO NOT TAKE ZOFRAN TABLETS 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 tablets (listed in Section 6). If you are not sure, talk to your doctor, nurse or pharmacist before taking Zofran table Pročitajte cijeli dokument
Health Products Regulatory Authority 24 November 2019 CRN0096QZ Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zofran 4 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains ondansetron 4mg as ondansetron hydrochloride dihydrate. Excipient with known effect: lactose For a full list of exciptents, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from Poland_ Yellow, oval, biconvex tablets GXET3 on the face and plain on the other face 4 CLINICAL PARTICULARS As per PA0896/036/005 5 PHARMACOLOGICAL PROPERTIES As per PA0896/036/005 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Core Lactose Anhydrous Microcrystalline cellulose Pregelatanised maize starch Magnesium stearate Film Coating Hypromellose Titanium dioxide (E171) Iron oxide yellow (E172) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the container and outer carton of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Health Products Regulatory Authority 24 November 2019 CRN0096QZ Page 2 of 2 Do not store above 30°C. 6.5 NATURE AND CONTENTS OF CONTAINER Zofran film-coated tablets are available in blister packs containing 10 tablets in an over-labelled outer carton. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT Swallow whole with a glass of water. 7 PARALLEL PRODUCT AUTHORISATION HOLDER IMED Healthcare Ltd. Unit 625 Kilshane Avenue Northwest Business Park Ballycoolin Dublin 15 Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1463/062/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 nd June 2012 10 DATE OF REVISION OF THE TEXT November 2019 Pročitajte cijeli dokument