দেশ: যুক্তরাজ্য
ভাষা: ইংরেজি
সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ondansetron
Healthcare Pharma Ltd
A04AA01
Ondansetron
8mg
Orodispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000; GTIN: 5060013779985
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, pharmacist or nurse. ! 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, pharmacist or nurse. 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 use 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 works by blocking signals in the brain that cause nausea and vomiting. Ondansetron Orodispersible Tablets are a special type of tablet 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, pharmacist or nurse 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 allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6) ! if you are taking apomorphine (used to treat Parkinson's disease). If you are not sure, talk to your doctor, pharmacist or nurse before taking Ondansetron Orodispersible সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ondansetron 4 mg orodispersible tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ One orodispersible tablet contains 8 mg ondansetron. Excipients with known effect: Each orodispersible tablet contains 19 mg lactose (as lactose monohydrate) and 6 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 t সম্পূর্ণ নথি পড়ুন