Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
LETROZOLE
Galenicum Health, S.L.U Calle Sant Gabriel, 50 Esplugues de Llobregat 08950 Barcelona, Spain
L02BG04
LETROZOLE 2.5 mg
FILM-COATED TABLET
LETROZOLE 2.5 mg
POM
ENDOCRINE THERAPY
Withdrawn
2013-07-25
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER LETROZOLE GALENICUM 2,5MG FILM-COATED TABLETS (letrozole) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. ‐ Keep this leaflet. You may need to read it again. ‐ If you have further questions, please 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 symptoms 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. WHAT IS IN THIS LEAFLET 1 What Letrozole Galenicum is and what it is used for 2 What you need to know before you take Letrozole Galenicum 3 How to take Letrozole Galenicum 4 Possible side effects 5 How to store Letrozole Galenicum 6 Contents of the pack and other information 1 WHAT LETROZOLE GALENICUM IS AND WHAT IT IS USED FOR WHAT LETROZOLE GALENICUM IS AND HOW IT WORKS Letrozole Galenicum contains an active substance called letrozole. It belongs to a group of medicines called aromatase inhibitors. It is a hormonal (or “endocrine”) breast cancer treatment. Growth of breast càncer is frequently stimulated by oestrogens which are female sex hormones. Letrozole Galenicum reduces the amount of oestrogen y blocking an enzyme (“aromatase”) involved in the production of oestrogens and therefore may block the growth of breast càncer 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 GALENICUM IS USED FOR Letrozole Galenicum is used to preventbreast 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 immedi Citiți documentul complet
Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Letrozole Galenicum 2.5mg, film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: 4, 4'-[(1H-1, 2, 4-triazol-1-yl)-methylene]bis-benzonitrile (INN/USAN = letrozole). Each film-coated tablet contains 2.5 mg letrozole. For a full list of excipients, see section 6.1 List of excipients 3. PHARMACEUTICAL FORM Film-coated tablets. Yellow, circular, biconvex, film coated tablets plain on both sides. 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 ADULT AND ELDERLY PATIENTS Posology _Adult and elderly patients _ The recommended dose of Letrozole Galenicum 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 Galenicum should continue until tumour progression is evident. In the adjuvant and extended setting, treatment with Letrozole Galenicum should continue for 5 years or until tumour r Citiți documentul complet