Country: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ondansetron hydrochloride dihydrate
Sandoz Ltd
A04AA01
Ondansetron hydrochloride dihydrate
8mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000
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 Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ondansetron 8 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains ondansetron 8mg (as ondansetron hydrochloride dihydrate). Excipients :Each tablet contains 146.5 mg lactose as lactose anhydrous lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet. Yellow, film coated oval shaped tablets, plain on both sides 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults: Management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, Prevention and treatment of post-operative nausea and vomiting (PONV). Paediatric Population: Management of chemotherapy-induced nausea and vomiting in children aged ≥ 6 months. Prevention and treatment of post-operative nausea and vomiting in children aged ≥ 1 month. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral use. _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 route of administration and dose of ondansetron should be flexible in the range of 8-32 mg a day and selected as shown below. Emetogenic Chemotherapy and Radiotherapy: Ondansetron can be given either by rectal, oral (tablets or syrup), intravenous or intramuscular administration. For oral administration: 8mg 1-2 hours before treatment, followed by 8mg 12 hours later. To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with ondansetron should be continued for up to 5 days after a course of treatment. The recommended dose for oral administration is 8mg twice daily. Highly Emetogenic Chemotherapy: For patients receiving highly emetogenic chemotherapy, e.g. high-dose cisplatin, ondansetron can be given by intravenous administration. To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with ondansetron should be continu Aqra d-dokument sħiħ