Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Letrozole
Medipha Sante SN
L02BG; L02BG04
Letrozole
2.5 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Aromatase inhibitors; letrozole
Not marketed
2011-02-25
_ _ PACKAGE LEAFLET: INFORMATION FOR THE USER LETROZOLE MEDIPHA SANTÉ 2.5 MG FILM-COATED TABLETS Letrozole 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 Letrozole Medipha Santé is and what it is used for 2. What you need to know before you take Letrozole Medipha Santé 3. How to take Letrozole Medipha Santé 4. Possible side effects 5. How to store Letrozole Medipha Santé 6. Contents of the pack and other information 1. WHAT LETROZOLE MEDIPHA SANTÉ IS AND WHAT IT IS USED FOR WHAT LETROZOLE MEDIPHA SANTÉ IS AND HOW IT WORKS Letrozole Medipha Santé contains an active substance called letrozole. It belongs to a group of medicines called aromatase inhibitors. It is an hormonal (or “endocrine”) breast cancer treatment. Growth of breast cancer is frequently stimulated by oestrogens which are female sex hormones. Letrozole Medipha Santé reduces the amount of oestrogen by blocking an enzyme (“aromatase”) involved in the production of oestrogens and therefore may block the growth of breast cancer that needs oestrogens to grow. As a consequence tumour cells slow or stop growing and/or spreading to other parts of the body. WHAT LETROZOLE MEDIPHA SANTÉ IS USED FOR Letrozole Medipha Santé is used to treat breast cancer in women who have gone through menopause i.e cessation of periods. It is used to prevent cancer from happening again. It can be used as first treatment before breast cancer surgery in case immediate surgery is not suitable or it can be used as first treatment after breast can Prečítajte si celý dokument
Health Products Regulatory Authority 14 October 2019 CRN009DDN Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Letrozole Medipha Sante 2.5mg film coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.5 mg letrozole. Each tablet contains 61.5 mg of lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Film-coated tablet, yellow, round, biconvex. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer. - Extended adjuvant treatment of hormone-dependent invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 years. - First-line treatment in postmenopausal women with hormone_-_dependent advanced breast cancer. - Advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status, who have previously been treated with anti-oestrogens. - Neo-adjuvant treatment of postmenopausal women with hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery not indicated. Efficacy has not been demonstrated in patients with hormone receptor negative breast cancer. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adult and elderly patients_ The recommended dose of letrozole is 2.5 mg once daily. No dose adjustment is required for elderly patients. In patients with advanced or metastatic breast cancer, treatment with letrozole should continue until tumour progression is evident. In the adjuvant and extended adjuvant setting, treatment with Letrozole Medipha Santé should continue for 5 years or until tumour relapse occurs, whichever is first. In the adjuvant setting a sequential treatment schedule (letrozole 2 years followed by tamoxifen 3 years) could also be considered (see sections 4.4 and 5.1). In the neoadjuvant setting, tr Prečítajte si celý dokument