Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Ondansetron
Originalis B.V.
A04AA; A04AA01
Ondansetron
4 milligram(s)
Oral lyophilisate
Product subject to prescription which may not be renewed (A)
Serotonin (5HT3) antagonists; ondansetron
2018-12-21
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, talk to your doctor, nurse or pharmacist before taking Zofran Zydis. WARNINGS AND PRECAUTIONS Check with your doctor or pharmacist before taking Zofran Zydis if: • you have ever had heart problems • you have an uneven heart beat (arrhythmias) • you are allergic to medicines similar to ondansetron, such as granisetron (known as ‘Kytril’) • you have liver problems • if you have a condition called phenylketonuria, which is an inability to break down amino acids • you have a blockage in your gut • you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium. If you are not sure if any of the above apply to you, talk to your Citiți documentul complet
Health Products Regulatory Authority 21 December 2018 CRN008N0L Page 1 of 2 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 4 mg ondansetron. Excipient(s) with known effect Each 4 mg oral lyophilisate contains aspartame (E951), sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral lyophilisate _Product imported from Spain_ White round oral lyophilisate. 4 CLINICAL PARTICULARS As per PA0896/036/007 5 PHARMACOLOGICAL PROPERTIES As per PA0896/036/007 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Gelatin Mannitol (E421) Aspartame (E951) Sodium methyl parahydroxybenzoate (E219) Sodium propyl parahydroxybenzoate (E217) Strawberry flavour (contains natural flavouring substances, artificial flavouring substances, propylene glycol (E1520)) 6.2 INCOMPATIBILITIES Not applicable. Health Products Regulatory Authority 21 December 2018 CRN008N0L Page 2 of 2 6.3 SHELF LIFE The shelf life expiry date of this product is the date shown on the blister and outer carton of the product as marketed in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30 °C. Store in the original package in order to protect from light and moisture. 6.5 NATURE AND CONTENTS OF CONTAINER Double foil blister packs. Blisters of 10 Zofran Zydis oral lyophilisate dosage units. 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 DO NOT attempt to push Zofran Zydis through the lidding foil. PEEL BACK the lidding foil of one blister and GENTLY remove the Zofran Zydis. Place the Zofran Zydis on top of the tongue, where it will disperse within seconds, then swallow. Any unused product should be disposed of in accordance with local requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER Citiți documentul complet