国家: 马耳他
语言: 英文
来源: Medicines Authority
GRANISETRON HYDROCHLORIDE
Sigillata Limited (Ireland) Inniscarra, Main Street, Rathcoole, Co. Dublin D24 E029 , Ireland
A04AA02
GRANISETRON HYDROCHLORIDE 1 mg
FILM-COATED TABLET
GRANISETRON HYDROCHLORIDE 1 mg
POM
ANTIEMETICS AND ANTINAUSEANTS
Authorised
2009-03-16
1 PACKAGE LEAFLET: INFORMATION FOR THE USER GRANISETRON SIGILLATA 1 MG FILM-COATED TABLETS GRANISETRON SIGILLATA 2 MG, FILM-COATED TABLETS Granisetron 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. Do not pass it on to others. It may harm them, even if their symptoms 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. IN THIS LEAFLET : 1. What Granisetron Sigillata is and what it is used for 2. What you need to know before you take Granisetron Sigillata 3. How to take Granisetron Sigillata 4. Possible side effects 5. How to store Granisetron Sigillata 6. Contents of the pack and other information 1. WHAT GRANISETRON SIGILLATA IS AND WHAT IT IS USED FOR Granisetron Sigillata contains the active substance granisetron. This belongs to a group of medicines called ‘5-HT 3 receptor antagonists’ or ‘anti-emetics’. These tablets are only for use in adults. Granisetron Sigillata is 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 SIGILLATA DO NOT TAKE GRANISETRON SIGILLATA • if you are allergic (hypersensitive) to granisetron or any of the other ingredients of Granisetron Sigillata (listed in section 6: Further information and “Important Information about some of the ingredients of Granisetron Sigillata” below). If you are not sure, talk to your doctor, nurse or pharmacist before taking these tablets. WARNINGS AND PRECAUTIONS Talk to your doctor, nurse or pharmacist before using these tablets, especially if you: • are having problems with your bowel movements because of a blockage 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Granisetron Sigillata 1 mg film-coated tablets Granisetron Sigillata 2 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1 mg granisetron as granisetron hydrochloride. Each film-coated tablet contains 2 mg granisetron as granisetron hydrochloride. Excipients with known effect: Each tablet contains 69.38 mg of lactose. Each tablet contains 138.76 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Appearance: 1 mg tablets: triangular, white, biconvex, film-coated tablets embossed with “G1” on one side. 2 mg tablets: triangular, white, biconvex, film-coated tablets embossed with “G2” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Granisetron tablets are indicated in adults for the prevention and treatment of acute nausea and vomiting associated with chemotherapy and radiotherapy. Granisetron 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 Sigillata 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. _Older people and renal impairment _ There are no special precautions required for its use in either elderly patients or those patients with renal 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 阅读完整的文件