Maa: Malta
Kieli: englanti
Lähde: Medicines Authority
GRANISETRON HYDROCHLORIDE
Sigillata Limited
A04AA02
GRANISETRON HYDROCHLORIDE
FILM-COATED TABLET
GRANISETRON HYDROCHLORIDE 2.24 milligram(s)
POM
ANTIEMETICS AND ANTINAUSEANTS
Authorised
2009-03-16
Page 1 of 6 PACKAGE LEAFLET Page 2 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER GRANISETRON ACTAVIS 1 MG FILM-COATED TABLETS GRANISETRON ACTAVIS 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Granisetron Actavis is and what it is used for 2. What you need to know before you take Granisetron Actavis 3. How to take Granisetron Actavis 4. Possible side effects 5. How to store Granisetron Actavis 6. Contents of the pack and other information 1. WHAT GRANISETRON ACTAVIS IS AND WHAT IT IS USED FOR Granisetron Actavis contains a medicine called 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 Actavis 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 ACTAVIS DO NOT TAKE GRANISETRON ACTAVIS - if you are allergic to granisetron or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking Granisetron Actavis - if you are having problems with your bowel movements because of a blockage in your gut (intestines) - if you have heart problems, are being treated for cancer with a medicine that is known to damage your heart or have problems with levels of salts, such as potassium, sodium or calcium, in your bo Lue koko asiakirja
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 9 1. NAME OF THE MEDICINAL PRODUCT Granisetron Actavis 1 mg film-coated tablets Granisetron Actavis 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. Excipient with known effect: Lactose (69.38 mg per film-coated tablet) (138.76 mg per tablet) 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 embossedwith “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 Actavis 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. Page 3 of 9 _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 Lue koko asiakirja