Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Granisetron hydrochloride
Atnahs Pharma Netherlands B.V.
A04AA; A04AA02
Granisetron hydrochloride
2 milligram(s)
Film-coated tablet
Serotonin (5HT3) antagonists; granisetron
Marketed
1998-05-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER KYTRIL 1 MG FILM-COATED TABLETS KYTRIL 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, nurse or pharmacist. - 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET : 1. What Kytril is and what it is used for 2. What you need to know before you take Kytril 3. How to take Kytril 4. Possible side effects 5. How to store Kytril 6. Contents of the pack and information 1. WHAT KYTRIL IS AND WHAT IT IS USED FOR Kytril 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. Kytril 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 KYTRIL DO NOT TAKE KYTRIL TABLETS • if you are allergic (hypersensitive) to granisetron or any of the other ingredients of Kytril (listed in section 6: Further information and “Important Information about some of the ingredients Kytril 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 of your gut (intestines) • 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 Prečítajte si celý dokument
Health Products Regulatory Authority 23 March 2021 CRN009X9N Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Kytril 2mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2mg granisetron (as the hydrochloride). Excipients with known effect: Each tablet contains 138.76 of lactose monohydrate Sodium starch glycolate For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. The tablets are white to almost-white, triangular, biconvex tablets imprinted with ‘K2’ on one side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kytril film-coated tablets are indicated in adults for the prevention and treatment of acute nausea and vomiting associated with chemotherapy and radiotherapy. Kytril 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 Kytril 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 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 Prečítajte si celý dokument