Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
gefitinib
AstraZeneca AB
L01XE02
gefitinib
Antineoplastic agents
Carcinoma, Non-Small-Cell Lung
Iressa is indicated for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer with activating mutations of epidermal-growth-factor-receptor tyrosine kinase.
Revision: 16
Authorised
2009-06-24
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IRESSA 250 MG FILM-COATED TABLETS gefitinib 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 IRESSA is and what it is used for 2. What you need to know before you take IRESSA 3. How to take IRESSA 4. Possible side effects 5. How to store IRESSA 6. Contents of the pack and other information 1. WHAT IRESSA IS AND WHAT IT IS USED FOR IRESSA contains the active substance gefitinib which blocks a protein called ‘epidermal growth factor receptor’ (EGFR). This protein is involved in the growth and spread of cancer cells. IRESSA is used to treat adults with non-small cell lung cancer. This cancer is a disease in which malignant (cancer) cells form in the tissues of the lung. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IRESSA DO NOT TAKE IRESSA if you are allergic to gefitinib or any of the other ingredients of this medicine (listed in section 6, ‘What IRESSA contains’). if you are breast-feeding. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking IRESSA if you have ever had any other lung problems. Some lung problems may get worse during treatment with IRESSA. if you have ever had problems with your liver. 32 CHILDREN AND ADOLESCENTS IRESSA is not indicated in children and adolescents under 18 years. OTHER MEDICINES AND IRESSA Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, tell your doctor or pharm Aqra d-dokument sħiħ
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT IRESSA 250 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 mg of gefitinib. Excipients with known effect: Each tablet contains 163.5 mg of lactose (as monohydrate). Each tablet contains 3.86 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets (tablet). Tablets are brown, round, biconvex, impressed with “IRESSA 250” on one side and plain on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS IRESSA is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (see section 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with IRESSA should be initiated and supervised by a physician experienced in the use of anti-cancer therapies. Posology The recommended posology of IRESSA is one 250 mg tablet once a day. If a dose is missed, it should be taken as soon as the patient remembers. If it is less than 12 hours to the next dose, the patient should not take the missed dose. Patients should not take a double dose (two doses at the same time) to make up for a forgotten dose. _Paediatric population_ The safety and efficacy of IRESSA in children and adolescents aged less than 18 years has not been established. There is no relevant use of gefitinib in the paediatric population in the indication of NSCLC. _Hepatic impairment_ Patients with moderate to severe hepatic impairment (Child-Pugh B or C) due to cirrhosis have increased plasma concentrations of gefitinib. These patients should be closely monitored for adverse events. Plasma concentrations were not increased in patients with elevated aspartate transaminase (AST), alkaline phosphatase or bilirubin due to liver metastases (see section 5.2). _Renal impairment_ No dose adjustment is required in patients with impaired renal function at creatinine clearance > 20 ml/min. Onl Aqra d-dokument sħiħ