Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ondansetron hydrochloride dihydrate
Waymade Healthcare Plc
A04AA01
Ondansetron hydrochloride dihydrate
8mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000
ZOFRAN ® 4 MG TABLETS ZOFRAN ® 8 MG TABLETS (ondansetron hydrochloride dihydrate) PATIENT INFORMATION LEAFLET 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 your medicine is Zofran 4mg Tablets or Zofran 8mg Tablets but will be referred to as Zofran tablets throughout 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 (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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOFRAN TABLETS DO NOT TAKE ZOFRAN TABLETS 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 tablets. WARNINGS AND PRECAUTION Perskaitykite visą dokumentą
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). Excipients 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 "GXET5" 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 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 challenge. _Emetogenic Chemotherapy and Radiotherapy:_ Zofran can be given either by rectal, oral (tablets or syrup), intravenous or intramuscular administration. For oral administration: 8mg taken1 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 hours before chemotherapy, may be used. Perskaitykite visą dokumentą