Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Ondansetron
IMED Healthcare Ltd.
A04AA; A04AA01
Ondansetron
Film-coated tablet
Serotonin (5HT3) antagonists; ondansetron
2022-03-25
PACKAGE LEAFLET: INFORMATION FOR THE USER ZOFRAN ® 4 MG FILM-COATED T ABLETS ZOFRAN ® 8 MG FILM-COATED T ABLETS 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 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 Les hele dokumentet
Health Products Regulatory Authority 11 April 2023 CRN00DHVS Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zofran 8 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 8 mg ondansetron (as hydrochloride dihydrate). Excipient(s) with known effect: lactose anhydrous For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from Greece_ Yellow, oval, biconvex tablets engraved GXET5 on one face and plain on the other face. 4 CLINICAL PARTICULARS As per PA0711/327/004 5 PHARMACOLOGICAL PROPERTIES As per PA0711/327/004 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Core Lactose anhydrous Microcrystalline cellulose Pregelatinised maize starch Magnesium stearate Film Coating Hypromellose Opaspray Yellow M-1-8429 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the blister and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store below 30°C. 6.5 NATURE AND CONTENTS OF CONTAINER Health Products Regulatory Authority 11 April 2023 CRN00DHVS Page 2 of 2 Blister packs of PVC/aluminium containing 15 film-coated tablets. 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 PPA1463/158/003 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 th March 2022 10 DATE OF REVISION OF THE TEXT April 2023 Les hele dokumentet