Држава: Велика Британија
Језик: Енглески
Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ondansetron
A A H Pharmaceuticals Ltd
A04AA01
Ondansetron
8mg
Orodispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000; GTIN: 5025903008996
PACKAGE LEAFLET: INFORMATION FOR THE USER Ondansetron 4mg and 8mg Orodispersible Tablets Ondansetron 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, 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 signs of illness are the same as yours. • If you get any side effects, talk to 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 Ondansetron Orodispersible Tablets are and what they are used for 2. What you need to know before you take Ondansetron Orodispersible Tablets 3. How to take Ondansetron Orodispersible Tablets 4. Possible side effects 5. How to store Ondansetron Orodispersible Tablets 6. Contents of the pack and other information 1. What Ondansetron Orodispersible Tablets are and what they are used for Ondansetron Orodispersible Tablets contain a medicine called ondansetron. This belongs to a group of medicines called anti-emetics. Ondansetron Orodispersible Tablets are a special type of tablets that dissolves very quickly when put on top of the tongue. Ondansetron Orodispersible 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 Ondansetron Orodispersible Tablets Do not take Ondansetron Orodispersible Tablets if: • you are taking apomorphine (used to treat Parkinson’s disease), • 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, nurse or pharmacist Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ondansetron 8mg Orodispersible Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains ondansetron 8mg. Excipient with known effect Each orodispersible tablet contains 6mg aspartame. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablets. Round, white to off-white, flat, bevelled edged, tablets plain on both the surfaces, having strawberry odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults: _ Ondansetron orodispersible tablets are indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Ondansetron orodispersible 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:_ _ _ Ondansetron 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: _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 (as orodispersible tablet, 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 Прочитајте комплетан документ