Nazione: Regno Unito
Lingua: inglese
Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ondansetron
Novartis Pharmaceuticals UK Ltd
A04AA01
Ondansetron
4mg
Oral lyophilisate
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000; GTIN: 5000123109043
Package Leaflet: Information for the User ZOFRAN ® MELT 4MG (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 symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. The name of this medicine is Zofran melt 4mg but will be referred to as Zofran melt throughout the remainder of this leaflet. WHAT IS IN THIS LEAFLET: 1. What Zofran melt is and what it is used for 2. What you need to know before you take Zofran melt 3. How to take Zofran melt 4. Possible side effects 5. How to store Zofran melt 6. Contents of the pack and other information Zofran melt contains a medicine called ondansetron. This belongs to a group of medicines called anti-emetics. Zofran melt is a special type of Zofran tablet that dissolves very quickly when put on top of the tongue. Zofran melt is used for: preventing nausea and vomiting caused by chemotherapy (in adults and children) or radiotherapy for cancer (adults only) preventing nausea and vomiting after surgery (adults only). Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses. DO NOT TAKE ZOFRAN MELT 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 melt (listed in Section 6). If you are not sure, talk to your doctor, nurse or pharmacist before taking Zofran melt. WARNINGS AND PRECAUTIONS Check with your doctor, nurse or pharmacist before taking Zof Leggi il documento completo
OBJECT 1 ZOFRAN MELT 4MG Summary of Product Characteristics Updated 13-Oct-2017 | Novartis Pharmaceuticals UK Ltd 1. Name of the medicinal product Zofran Melt 4 mg Zofran Melt 8 mg 2. Qualitative and quantitative composition Zofran Melt 4 mg Each Melt contains ondansetron 4 mg. Excipients with known effect: Each 4 mg Melt contains 625 micrograms of aspartame (E951), 56 micrograms sodium methyl para-hydroxybenzoate (E219) and 6.9 micrograms of sodium propyl para- hydroxybenzoate (E217). Zofran Melt 8 mg Each Melt contains ondansetron 8 mg. Excipients with known effect: Each 8 mg Melt contains 1.25 mg of aspartame (E951), 110 micrograms sodium methyl para hydroxybenzoate (E219) and 14 micrograms of sodium propyl para hydroxybenzoate (E217). For a full list of excipients, see section 6.1. 3. Pharmaceutical form Oral lyophilisate. White, round, plano-convex, freeze dried, fast dispersing oral dosage form. 4. Clinical particulars 4.1 Therapeutic indications _Adults:_ Zofran Melt is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Zofran Melt is indicated for the prevention of post-operative nausea and vomiting (PONV). For treatment of established PONV, administration by injection is recommended. _Paediatric Population:_ Zofran is indicated for the management of chemotherapy-induced nausea and vomiting (CINV) in children aged ≥6 months No studies have been conducted on the use of orally administered ondansetron in the prevention and treatment of PONV in children aged ≥1 month, administration by IV injection is recommended for this purpose. 4.2 Posology and method of administration Place the Melt on top of the tongue, where it will disperse within seconds, then swallow. Chemotherapy and radiotherapy induced nausea and vomiting. _Adults:_ 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 cha Leggi il documento completo