Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ondansetron hydrochloride dihydrate
Milpharm Ltd
A04AA01
Ondansetron hydrochloride dihydrate
4mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000; GTIN: 8901175017096 8901175017102
WHAT IS IN THIS LEAFLET: 1. What Ondansetron is and what it is used for 2. What you need to know before you take Ondansetron 3. How to take Ondansetron 4. Possible side effects 5. How to store Ondansetron 6. Contents of the pack and other information Ondansetron belongs to a group of medicines called anti-emetics, drugs against feeling sick (nausea) or being sick (vomiting). This medicine is used for: • preventing nausea (feeling sick) and vomiting (being sick) caused by chemotherapy (in adults and children) or radiotherapy for cancer (adults only), • preventing nausea and vomiting after surgery (adults only). DO NOT TAKE ONDANSETRON • if you are taking apomorphine, a medicine used to treat Parkinson's disease, • if you are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Ondansetron: • if you have ever had heart problems (e.g. congestive heart failure which causes shortness of breath and swollen ankles), • if you have an uneven heart beat (arrhythmias), • if you are allergic to medicines similar to ondansetron, such as granisetron or palonosetron, • if you have liver problems, • if you suffer from any blockage in your gut or if you have severe constipation, • if your blood levels of potassium or magnesium are reduced, • if you are having your tonsils out. OTHER MEDICINES AND ONDANSETRON Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Ondansetron 4 mg / 8 mg Film-coated Tablets can affect the way some medicines work. Also some other medicines can affect the way Ondansetron 4 mg / 8 mg Film-coated Tablets works. In particular, tell your doctor or pharmacist: • if you are taking phenytoin, carbamazepine PACKAGE LEAFLET: INFORMATION FOR THE PATIENT (used to treat epilepsy or other illnesses), or rifampicin (used to treat c Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ondansetron 4 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains ondansetron hydrochloride dihydrate equivalent to 4 mg ondansetron. Excipients with known effect: Each film-coated tablet contains 74.25 mg of lactose (as anhydrous and as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Yellow, oval shaped, plain on both sides 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults: Management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Prevention of post-operative nausea and vomiting (PONV). For treatment of established PONV, administration by injection is recommended. Paediatric population: 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_ _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: Ondansetron can be given either by rectal, oral (tablets or syrup), intravenous or intramuscular administration. For oral administration: 8 mg 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 ondansetron tablet taken with 12 mg oral dexamethasone sodium phosphate, 1 to 2 hours before chemotherapy, may be used. To protect against delayed or prolonged emesis Perskaitykite visą dokumentą