Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ondansetron
Aristo Pharma Ltd
A04AA01
Ondansetron
4mg
Orodispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000; GTIN: 4251575902336
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 1. What Ondansetron is and what it is used for This medicine contains Ondansetron, which belongs to a group of medicines called anti-emetics which help to stop you feeling or being sick. Ondansetron is used to treat nausea (feeling sick) and vomiting (being sick) caused by some medical treatments, such as chemotherapy or radiotherapy for cancer (in adults and children). It is also used to prevent nausea and vomiting in patients following an operation (adults only). 2. What you need to know before you take Ondansetron Do not take Ondansetron • if you are allergic to ondansetron, benzyl alcohol, sulphites or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”) • if you are taking apomorphine (a medicine used to treat Parkinson’s disease). Do not give the tablets to children with a body surface area of less than 0.6 m 2 or weighing up to 10 kg. Warnings and precautions Talk to your doctor or pharmacist before taking Ondansetron • if you are allergic to medicines (5-HT 3 antagonists) similar to ondansetron • if you are due to have surgery to the adenoids or tonsils • if you have heart problems including irregular heartbeat (arrhythmia) • if you are taking certain medicines to treat depression and/or anxiety (selective serotonin reuptake inhibitors [SSRIs] such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram and escitalopram or selective noradrenaline reuptake inhibitors [SNRIs] such as venlafaxine or duloxetine) • if you have digestive problems • if you have liver problems, in which case your doctor will possibly reduce your ondansetron dose • if you have problems with salt levels in your blood (electrolyte disorders), e.g. potassium and magnesium. If you think any of the a Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ondansetron 4 mg orodispersible tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ One orodispersible tablet contains 4 mg ondansetron. Excipients with known effect: Each orodispersible tablet contains 9.5 mg lactose (as lactose monohydrate) and 3 mg aspartame (E951). This medicine contains up to 100 microgram benzyl alcohol in each orodispersible tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet. _ _ White to off-white, round tablets debossed with ‘5’ on one side and ‘E’ on the other side with an embossed circular edge 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults Ondansetron is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention and treatment of post-operative nausea and vomiting (PONV). Paediatric population Ondansetron is indicated for the management of chemotherapy-induced nausea and vomiting (CINV) in children aged ≥ 6 months, and for the prevention and treatment of PONV in children aged ≥ 1 month. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Chemotherapy and radiotherapy induced nausea and vomiting The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. Selection of the dose and dosing regimen must therefore be guided by the emetogenic potential. _ _ _Adults_ The recommended oral dose is 8 mg, taken 1-2 hours prior to chemotherapy or radiation, followed by 8 mg orally every 12 hours over a maximum of 5 days. In highly emetogenic chemotherapy, a single oral dose up to a maximum of 24 mg ondansetron can be given orally together with 12 mg dexamethasone-21-dihydrogen phosphate disodium salt or equivalent 1 to 2 hours prior to chemotherapy. After the first 24 hours, ondansetron treatment can be continued orally for up to 5 days after a course of treatment. The recommended dose is 8 mg twice daily. For Đọc toàn bộ tài liệu