Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ondansetron hydrochloride dihydrate
Novartis Pharmaceuticals UK Ltd
A04AA01
Ondansetron hydrochloride dihydrate
8mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000; GTIN: 5000123105182
www.perigord-as.com Artwork creator: Printing colours: Print enhancements: Technical colours: Cutting Artwork Order No. AW identifier No. New: Artwork Order description: Packaging site: Dimension: Tech. Drawing No.: Live text: Condensed font: Font type: Minimum font size body text: Variable data prefixes font size: Braille: AW identifier No. Old: Creation date: Proof No.: Perigord 03 Aug 2022 1 300032512 LEAFLET_ZOFRAN_FCT_ALL_GB 300032512-GB N/A CM, DE, BAD OLDESLOE, ASPEN (IM) Frutiger LT Pro 8 pt N/A N/A Yes Yes No No Both BE12_170x297_V04 170 X 297 MM Dimensions Black N/A www.perigord-as.com ! P L E A S E T U R N O V E R P R I N T I N G O N ! 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER ZOFRAN ® TABLETS 4 MG AND 8 MG ONDANSETRON (AS HYDROCHLORIDE DIHYDRATE) 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. 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 (in adults and children) or radiotherapy for cancer (adults only) • preventing nausea Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zofran Tablets 8 mg. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains ondansetron 8 mg (as hydrochloride dihydrate). Excipient(s) with known effect: Contains lactose (anhydrous) 163.75 mg (see section 4.4). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Yellow, oval, film-coated tablet engraved with "GX ET5" on one face and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults: _ Zofran tablets are indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Zofran tablets are 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 Posology Chemotherapy and radiotherapy induced nausea and vomiting (CINV and RINV) _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 challenge. _Emetogenic Chemotherapy and Radiotherapy: _Zofran can be given either by rectal, oral (tablets or syrup), intravenous or intramuscular administration. The recommended oral dose is 8mg taken 1 to 2 hours before chemotherapy or radiation treatment, followed by 8 mg every 12 hours for a maximum of 5 days to protect against delayed or prolonged emesis. _For highly emetogenic chemotherapy_ a single dose of up to 24 mg Zofran taken with 12 mg oral dexamethasone sodium phosphate, 1 to 2 hou Izlasiet visu dokumentu