国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Granisetron hydrochloride
Alliance Healthcare (Distribution) Ltd
A04AA02
Granisetron hydrochloride
2mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000
PACKAGE LEAFLET: INFORMATION FOR THE USER GRANISETRON 1 MG FILM-COATED TABLETS GRANISETRON 2 MG FILM-COATED TABLETS 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 Granisetron Film-coated Tablets are and what they are used for 2. What you need to know before you take Granisetron Film-coated Tablets 3. How to take Granisetron Film-coated Tablets 4. Possible side effects 5. How to store Granisetron Film-coated Tablets 6. Contents of the pack and other information 1. WHAT GRANISETRON FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR Granisetron belongs to a group of medicines called ‘5-HT 3 receptor antagonists’ or ‘anti- emetics’. These tablets are only for use in adults. Granisetron Film-coated Tablets are used to prevent or treat nausea and vomiting (feeling and being sick) caused by other medical treatments, such as chemotherapy or radiotherapy for cancer. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GRANISETRON FILM-COATED TABLETS DO NOT TAKE GRANISETRON FILM-COATED TABLETS: • if you are allergic to granisetron, or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor, pharmacist or nurse before taking these tablets. WARNINGS AND PRECAUTIONS Check with your doctor, pharmacist or nurse before using these tablets, if you: • are having problems with your BOWEL MOVEMENTS because of a blockage of your gut (intestines) • have HEART PROBLEMS , are being treated for cancer with a medicine that is known to damage 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Granisetron 2 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2 mg granisetron (as the hydrochloride) Excipients with known effect: Each tablet contains 138.76 mg of lactose Sodium starch glycolate For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. Triangular white, biconvex, film-coated tablets with G2 engraved on one side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Granisetron film coated tablets are indicated in adults for the prevention and treatment of acute nausea and vomiting associated with chemotherapy and radiotherapy. Granisetron film coated tablets are indicated in adults for prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 1 mg twice a day or 2 mg once a day for up to one week following radiotherapy or chemotherapy. The first dose of Granisetron film coated tablets should be administered within 1 hour before the start of therapy. Dexamethasone has been used concomitantly at doses up to 20 mg once a day orally. _ _ _Paediatric population _ The safety and efficacy of granisetron tablets in children have not yet been established. No data are available. _ _ _Elderly and renal impairment_ There are no special precautions required for its use in either elderly patients or those patients with renal or hepatic impairment. _Hepatic impairment_ There is no evidence to date for an increased incidence of adverse events in patients with hepatic disorders. On the basis of its kinetics, whilst no dosage adjustment is necessary, granisetron should be used with a certain amount of caution in this patient group (see section 5.2). Method of administration The tablets should be swallowed whole with water. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As gra 完全なドキュメントを読む